A B S T R ACT S

KURZ IMPLANTS, PRECISION INSTRUMENTS, VENTILATION TUBES

NOVEMBER 2018

MIDDLE EAR INTELLIGENCE

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T T P -VA R I AC SYS T E M 5

T T P -VA R I O SYS T E M 6

T T P -T U E B I N G E N T Y P E P R O S T H E S I S 6

DUESSELDORF TYPE PROSTHESIS 7

M N P M A L L E U S N OTC H P R O S T H E S I S 9

O M E GA C O N N E CTO R 9

M R P M A L L E U S R E P L AC E M E N T P R O S T H E S I S 10

C L I P PA R T I A L F L E X I B A L 10

C L I P PA R T I A L P R O S T H E S I S D R E S D E N T Y P E 11

ANGULAR CLIP PROSTHESIS 12

R E G E N S B U R G T Y P E TOTA L P R O S T H E S I S 13

NITIFLEX 13

M AT R I X 13

K- P I S TO N 14

SOFT CLIP 14

C L I P P I S TO N À W E N G E N 16

C L I P P I S TO N M V P 17

NITIBOND 18

S TA P E S P R O S T H E S E S 19

K U R Z P R E C I S E CA R T I L AG E K N I F E 20

CA R T I L AG E P U N C H 21

TENS ION 22

TOTA L A N D PA R T I A L R E C O N S T R U CT I O N 23

TITANIUM AND OTHER MATER IALS 24

MRI 27

COUPLING OS S ICULOPL ASTY 27

VENTIL ATION TUBES 28

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 ABSTRACTS
KURZ IMPLANTS, PRECISION INSTRUMENTS, VENTILATION TUBES
MIDDLE EAR SURGERY

T T P -VA R I A C SY S T E M Titanium implants in middle ear surgery were introduced in the late 90s
and are now frequently used in middle ear surgery. However, long-term
studies of patient outcome are few and have only been published in sub-
Middle Ear Reconstruction Using the Titanium groups of patients. We report the long-term effect of titanium middle ear
Kurz Variac Partial Ossicular Replacement Prosthesis implants for ossicular reconstruction in chronic ear disease investigated in
a Norwegian tertiary otological referral centre. Retrospective chart reviews
Meulemans J., Wuyts F. L., Forton G. E. J. were performed for procedures involving 76 titanium implants between
2000 and 2007. All patients who underwent surgery using the Kurz Vario
Published: JAMA Otolaryngol Head Neck Surg. 2013 Oct titanium implant were included in the study. Audiological parameters using
139(10):1017-25. DOI: 10.1001/jamaoto.2013.4751 four frequencies, 0.5, 1, 2, and 3 kHz, according to AAO-HNS guidelines,
was assessed pre and postoperatively. Otosurgical procedures, complica-
Importance: Satisfactory functional results following ossicular chain re- tions, revisions, and extrusion rates were analyzed. The study had no drop-
construction mainly depend on a stable connection between the tympanic outs. The partial ossicular replacement prosthesis (PORP) was used in 44
membrane and the stapes, which is in turn dependent on the type of prosthe- procedures and the total ossicular replacement prosthesis (TORP) in 32
sis used. Knowledge about the safety and functional outcome of the com- procedures, respectively. Mean follow-up was 5.2 years (62 months). The
mercially available middle ear prostheses is therefore of great importance. ossiculoplasties were performed as staging procedures or in combination
with other chronic ear surgery. The same surgeon performed all the proce-
Objective: To evaluate the efficacy and safety of the Kurz TTP-Variac dures. A postoperative air-bone gap of ≤ 20 dB was obtained in 74 % of
System partial ossicular replacement prosthesis (PORP) in ossiculoplasty. the patients, 82 % for the Bell (PORP) prosthesis, and 63 % for the Arial
(TORP) prosthesis. The extrusion rate was 5 %.
Design, Setting and Participiants: Retrospective review of all ossicu-
loplasties performed by 1 surgeon at a secondary referral center from Au- We conclude that titanium ossicular implants give stable and excellent long-
gust 2006 through July 2012. Participants were patients with cholesteato- term hearing results.
ma, chronic otitis media, or ossicular chain disruption in the absence of
inflammatory disease who underwent ossicular reconstruction.
Variable length titanium prostheses for
Exposure: Ossiculoplasty using a Kurz TTP-Variac System PORP. type III tympanoplasty. Intraoperative length adjustment
and fixation of the cartilage overlay
Main Outcome and Measures: Mean preoperative and postoperative
air-bone gaps (ABGs) and improvements in ABG were analyzed for each Zenner H.-P., Zimmermann R., Steinhardt U., Maassen M. M.
frequency by means of a 4-frequency pure-tone average. Successful post-
operative hearing was defined as postoperative ABG smaller than 20 dB. Published: HNO 01 Apr 2006, 54(4):298-302 (German)
DOI: 10.1007/s00106-006-1391-x
Results: Eighty-nine ears in 83 patients aged 7 to 85 years were included.
Transmeatal tympanoplasty was performed in 17 ears (19%). Seven ears Introduction: For type III tympanoplasty by partial ossicular replacement
(8%) underwent tympanoplasty with canal wall-down mastoidectomy, and prosthesis (PORP) or total ossicular replacement prosthesis (TORP), the
65 ears (73%) underwent canal wall-up (combined approach) tympano- length of the prosthesis must match the individual intraoperative anatomical
plasty with mastoidectomy. The study population comprised 61 primary and physiological characteristics.
tympanoplasties (69%) and 28 revision cases (31%). Mean follow-up was
13 months. Overall, the ABG significantly improved from a mean (SD; Materials and Methods: Databanks were used to determine the necessary
range) of 26.19 (11.53; 3.75-51.25) dB to 15.58 (9.80; 0-48.75) dB (P < sizer length of the sizer disc. The measurement template for the size of the
.01 for all frequencies). Mean ABG improvement was 10.62 dB. Success- cartilage to overlay the prosthesis headplate was derived from the headplates
ful postoperative hearing was obtained in 65 ears (73%). Revision surgery, of the Tuebinger titanium prostheses (TTP®) and the Dresdener titanium
especially in ears with ossicular chain disruption without inflammatory prostheses. Finally all functions were integrated into a synthetic plate.
disease, was associated with poorer functional outcome, whereas pres-
ervation of the malleus was associated with a better functional outcome Results: The result was a simple and reasonably priced disposable multi-
(P < .05). There were few complications (1 prosthesis extrusion, 2 pros- functional instrument (Tuebinger sizer disc TSD) which allowed an exact
thesis dislocations, 2 reperforations, 3 cases of residual cholesteatoma, and measurement for every prosthesis in TORP and PORP. For the TTP®-
3 of light sensorineural hearing loss). Variac, the TSD enabled the simple intraoperative production of prostheses with
the length desired by the surgeon. For PORP the TSD enabled an adaptation of
Conclusion and Relevance: The titanium Kurz TTP-Variac System PORP the diameter of the prosthesis foot for TTP®, TTP®-Vario and TTP®-Variac
is an effective prosthesis to reconstruct the ossicular chain. Complications and provided a template for the size determination of the cartilage overlay of
are rare, illustrating the safety of the prosthesis. the titanium prosthesis head. The sizers and the resulting prostheses were used
for initial tympanoplastic operations. Audiometric investigations carried out
6 weeks postoperatively gave results corresponding to those previously ob-
Long-term hearing result using Kurz titanium ossicular implants tained in a study with TTP® and TTP®-Vario using the old instrumentation.

Hess-Erga J., Møller P., Vassbotn F. S. Conclusions: The new instrumentation leads to an improvement of the
intraoperative practicability and a simplification. The audiological results
Published: European Archives of Oto-Rhino-Laryngology, May 2013 remain the same.
DOI: 10.1007/s00405-012-2218-x

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Ossiculoplasty with KURZ titanium prosthesis Published: 24th Politzer Meeting 31 August – 4 September 2003, Amster-
dam, the Netherlands: Selected Abstracts
Nguyen D.-Q., Morel N., Dumas G., Troussier J., Lavieille J.-P.,
Schmerber S. Titanium has been an accepted prosthetic material for decades in cra-
niofacial and orthopaedic surgery. The last decennium, studies were
Published: Ann Otolaryngol Chir Cervicofac. 2005 Sep;122(4):187-93. published reporting the results of titanium prostheses used for ossicu-
(French) loplasty. The new. lightweight titanium prostheses are designed to maxi-
mize visualization of the capitulum and footplate region. Mechanical-
Objectives: Report the functional and anatomic results of ossicular recon- ly they are characterized by a high degree of rigidity and low weight.
struction by titanium prosthesis. Acoustically they have low sound damping, low acoustic impedance,
and a second resonance that might increase to broadband frequen-
Materials and Methods: Retrospective chart reviews were performed for cy transmission. These characteristics suggest the possibility of im-
111 patients who had undergone titanium ossicular implants between No- proved signal transfer in the main speech frequencies at around 2 kHz.
vember 1998 and 2002 (61 PORP, 50 TORP). The anatomical and audio- A prospective clinical study was started to evaluate the efficacy of the vari-
metric data were analyzed on average at 3 and 20 months. able (= adjustable length) Tübingen titanium prosthesis (TTP-Vario). Twen-
ty patients were evaluated. A canal wall up procedure was performed in 3
Results: At 20 months, the improvement of air-bone-gap mean was 12.7 cases, a canal wall down procedure in 17 cases. A postoperative air bone gap
dB with better results at low frequencies. The global success rate was 66% of < 20 dB was obtained in 60% of bell prosthesis patients and < 25dB in
(PORP 77%, TORP 52%). It decreased significantly in the open techniques. all bell prosthesis patients. The pure-tone average air-bone gap for the aerial
Extrusion rate was low (2/111) and the labyrinthization rate was 3.6%. prosthesis was < 20 dB in 43%, < 25 dB in 64% and < 30 dB in 85% at 1
Twenty patients required a surgical revision (18%). In 9 patients, the pros- month. The results were stable or improved for later time intervals. To date
thesis was too short. At long-term follow-up, the gains were stable in 60 there have been no extrusion. The surgeon finds the prosthesis easy to han-
patients, improved in 32 patients and worsened in 19 patients. dle and the open head of the prosthesis facilitates correct placement on the
capitulum of the stapes or on the footplate. From a surgical point of view,
Conclusion: The success rate is higher in the group of the PORP with the the Kurz titanium prosthesis is an excellent middle ear prosthesis due to the
closed technique. The stability of the TORP in open technique still remains design and the possibility of individual adjustment. The hearing results are
problematic. In all cases, the risk of extrusion requires a large cartilage graft good. Further studies are needed to confirm long-term efficacy.
recovering the plate of the prosthesis. The high rate of luxation (9/111 pros-
thesis too short) has led us to increase slightly the length of the prosthesis
(+1.22 mm mean).
T T P -T U E B I N G E N T Y P E P R O S T H E S I S

T T P -VA R I O SY S T E M Ossiculoplasty With Titanium Prosthesis

Martins J., Silva H., Certal V. F., Amorim H., Carvalho C. F.

Synchronous ossiculoplasty with titanium prosthesis
during canal wall down surgery for advanced cholesteatoma: Published: Acta Otorrinolaringológica Española. Accepted 27 February 2011
anatomical and hearing outcomes DOI: 10.1016/j.otoeng.2011.02.004

Iseri M., Ustundag E., Ulubil S. A., Ozturk M., Bircan O. Objectives: The goal of this study was to make a review of the patients who
underwent Ossicular chain reconstruction with titanium prosthesis during
Published: The Journal of Laryngology & Otology (2012), 126, 131–135. an 8-year period in our Department.
DOI: 10.1017/S0022215111002520
Methods: A retrospective study was made on the ossiculoplasty cases
Objective: To analyse patients with cholesteatoma undergoing canal over a period of eight years in a Public Hospital District. The information
wall down mastoidectomy together with ossicular reconstruction with a was extracted by clinical process consultation. Between 1999 and 2008,
titanium prosthesis, in order to identify factors associated with hearing 124 ossiculoplasties using Kurz® titanium prosthesis for chronic otitis
outcomes. media were performed (78 partial ossicular chain reconstructions and 46
total Ossicular chain reconstructions). The single stage, staged and revi-
Study Design: Retrospective review of 97 cases undergoing single-stage sion ossicular chain reconstruction were included in the analysis. All pa-
surgical management. tients had a minimum of 6-month postoperative follow-up (mean 3 years
and 4 months). Comparisons of preoperative and postoperative pure tone
Methods: All patients underwent canal wall down mastoidectomy. Kurz averages were performed. Air-bone gap and implant extrusion rates were
titanium ossicular prostheses were used for ossicular chain reconstruction. measured. The success of the reconstruction was defined as a postopera-
Pre-operative and post-operative air conduction and bone conduction hear- tive air-bone gap (ABG) of 20 dB or better.
ing thresholds were obtained at 500, 1000, 2000 and 3000 Hz.
Results: Successful ossiculoplasty was obtained in 73.1% of partial ossicu-
Results: The mean pure tone average improved from 46.02 ± 14.54 dB lar chain reconstructions and 30.4% of total ossicular chain reconstructions
pre-operatively to 29.32 ± 14.64 dB postoperatively, for both total and (P < 05). The postoperative pure-tone average air-bone gaps was 16 dB in
partial ossicular replacement prosthesis groups combined. The mean air– partial reconstructions and 26.7 dB in total reconstructions (P < 05). There
bone gap improved from 30.38 ± 11.12 dB pre-operatively to 15.62 ± 9.65 were five cases of prosthesis extrusion.
dB post-operatively, for both groups combined.
Conclusions: The majority of the ossiculoplasties improved the hearing sta-
Conclusion: Reconstruction with a titanium prosthesis offers good func- tus satisfactorily. There was no difference in hearing results in one-stage and
tional results when performed during canal wall down surgery for ad- two-stage partial ossicular chain reconstruction, but there were better hearing
vanced cholesteatoma as a single-stage procedere. results in the cases of two-stage total Ossicular chain reconstruction.

Preliminary ossiculoplasty results using the Kurz® titanium Hearing results with the titanium ossicular
middle ear implants replacement prostheses

Heylbroeck Ph., De Vel E., Dhooge I. Schmerber S., Troussier J., Dumas G., Lavieille J.-P., Nguyen D. Q.

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Published: Eur Arch Otorhinolaryngol (2006) 263: 347-354. Open Tuebingen Titanium Prostheses for Ossiculoplasty:
DOI: 10.1007/s00405-005-1002-6 A Prospective Clinical Trial

The purpose was to study the hearing results in patients receiving a Kurz Zenner H. P., Stegmaier A., Lehner R., Baumann I.,
titanium Bell partial ossicular replacement prosthesis (PORP) or an Aerial Zimmermann R.
total ossicular replacement prosthesis (TORP). The study was a retrospective
chart review in a tertiary otologic referral center. A computerized otologic Published: Otology & Neurotology 2001, 22:582-589
database was used to identify 111 patients implanted with either a PORP or
TORP prosthesis. Audiograms were reviewed and air-bone gaps were calcu- Objective: The overall purpose of the study was the evaluation of the effi-
lated for each patient. The improvement of the average air-bone gap (ABG) cacy of Tübingen titanium prostheses (TTPs) for ossiculoplasty.
was 10.2 and 12.7 dB at 3 and 20 months after ossiculoplasty, respectively.
Sixty-six percent of patients (73/111) had a postoperative air-bone gap of Study Design: A two-part clinical study of 216 patients undergoing ossic-
20 dB or less. The ABG for the titanium PORP prosthesis was 14.3+/-9.7 uloplasty was performed. The first part was a prospective study using TTPs
dB, compared with 25.2+/-13.7 dB for the TORP prosthesis (P < 0.05). The (n = 114). The second part involved study of historical control patients (n =
ABG to within 20 dB or less was obtained in the PORP group in 77% of the 102) with gold and ceramic prostheses. Interventions: All patients under-
cases, versus 52% of the cases in the TORP group ( P < 0.05). Two extrusions went ossiculoplasty.
of the prostheses were observed at 17 and 20 months after surgery (1.8%).
Revision procedures for functional failure were carried out in 20 patients Main Outcome Measures: Measures included median air conduction
(18%). The rate of sensorineural hearing loss was 3.6%. The major factors thresholds and air-bone gaps.
influencing good audiometric results were the surgical procedure preserving
the external auditory canal and the presence of the stapes. The best hearing Results: All patients were per-protocol patients. When the air-bone gap
results were achieved when a PORP was used in an intact canal wall (ICW) “gold standard” (i.e., ≤ 10 dB) was investigated in the main speech spec-
procedure, and the worst hearing results were achieved when a TORP was trum, partial TTPs reached this level at 2 kHz in 44% (n = 22) and at 3 kHz
used in a canal wall down (CWD) procedure. The titanium Kurz prosthesis in 38% (n = 19). Gold and ceramics revealed significantly lower values.
has been an effective implant at our institution for ossicular reconstruction. Similar results were obtained for total prostheses. Differences for TTPs and
ceramics were statistically significant (Mann-Whitney U test, α = 5%).

Accoustomechanical properties of open Conclusion: The use of TTPs for ossiculoplasty is an efficient treatment method.
TTP® titanium middle ear prostheses

Zenner H.P., Freitag H.- G., Linti C., Steinhardt U., Rodriguez
J. J., Preyer S., Mauz P.-S., Sürth M., Plank H., Baumann I., DUESSELDORF TYPE PROSTHESIS
Lehner R., Eiber A.

Published: Hearing Research. 2004 Jun;192(1-2):36-46. Ossiculoplasty with titanium prostheses

DOI: 10.1016/j.heares.2004.02.004
Romer M., Vorburger M., Huber A.
Objective: The purpose of the study was to identify acoustcomechanical
properties of various biostable and biocompatible materials to create a Published: MEMRO 2006, 4th International Symposium on Middle Ear
middle ear prosthesis with the following properties: (i) improved handling Mechanics in Research and Otology: Selected Abstracts
including a good view of the head of the stapes or footplate and adjust-
able length, (ii) improved acoustical characteristics that are adequate for Objective: To determine the hearing results and the complication rate one
ossiculoplastic. The identified material should serve to build CE and FDA year after ossiculoplasty with the Kurz titanium system.
approved prostheses for clinical use in patients.
Material and Methods: A retrospective chart review of 82 procedures in 77
Methods: Test models made of Teflon, polyetheretherketone, polyethylen- patients. Included in the study were 36 Aerial-TORP and 46 Bell-PORP be-
terephtalate, polysulfone, gold, Al2O3 ceramics, carbon and titanium were tween October 2001 and October 2004. The air and bone conduction thresh-
investigated for their potential to fulfill the requirements. Acoustical prop- olds as well as the complication ratewere evaluated.
erties were investigated by laser Doppler velocimetry (LDV) in mechan-
ical middle ear models (MMM). Measured data were fed in to a recently Results: The mean preoperative air bone gap (ABG) was 32,9 (+/-13,4) dB.
created computer model of the middle ear (multibody systems approach, 16 (+/-7,2) months postoperatively the average ABG was 17,6 (+/-11,8) dB.
MBS). Using computer-aided design (CAD) measured and computed data The extrusion rate was 3/82 (3,7%). In one case (1,2%) the prosthesis per-
allowed creation and fine precision of titanium prostheses (Tubingen Tita- forated the stapes footplate and was dislocated into the vestibule without
nium Protheses, TTP). Their handling was tested in temporal bones. Acous- significant sensorineural hearing loss. The tympanic membrane reperfora-
tomechanical properties were investigated using the MBS and mechanical tion rate and the cholesteatoma recurrence rate was 3/82 (3,7%) and 1/82
middle ear models. (1,2%) respectively.

Main Outcome Measures: Input impedance, mass, stiffness, and geometry Conclusion: The Kurz titanium prosthesis system provides hearing success
of test models and prostheses were determined. Furthermore, their influence comparable with current ossiculoplasty studies and low complication rate.
on the intraprosthetic transfer functions and on coupling to either tympanic
membrane or stapes was investigated.
Results with Titanium Ossicular Reconstruction Prostheses
Results: Final results were FDA- and CE-approved filigreed titanium pros-
theses with an open head that fulfilled the four requirements detailed above. Gardner E. K., Jackson C. G., Kaylie D. M.
The prostheses (TTP) were developed in defined lengths of between 1.75
and 3.5 mm (partial) and 3.0 and 6.5 mm (total) as well as in adjustable Published: Laryngoscope 2004 Jan;114(1): 65-70.
lengths (TTP-Vario). DOI: 10.1097/00005537-200401000-00011

Conclusions: The results suggest acoustomechanical advantages of TTPs Objectives /Hypothesis: Despite the enthusiasm of recent short-term re-
because they combine a significantly low mass with high stiffness. In con- views, no center in the United States has published results meeting Amer-
trast to closed prostheses, the open head and filigreed design allow an ex- ican Academy of Otolaryngology-Head and Neck Surgery guidelines with
cellent view of the prosthesis foot during coupling to the head or footplate titanium-based prostheses. The purpose of the study was threefold. The first
of stapes, contributing to an improved intraoperative reliability of prosthesis purpose was to review results with a titanium prosthesis system in cases
coupling. meeting American Academy of Otolaryngology-Head and Neck Surgery

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reporting guidelines. The second was to compare these results with previ- Reconstruction of the ossicular chain with titanium implants.
ously published results using non-titanium-based prostheses. The third was Results of a multicenter study
to examine the authors’ results for any evidence of a “learning curve.”
Begall K., Zimmermann H.
Study Design: Retrospective chart review was performed for the period
from February 2000 to August 2001 and for the period from July 2002 to Published: Laryngo-Rhino-Otol 2000, 79 (3):139-145. (German)
February 2003. DOI: 10.1055/s-2000-298

Methods: Of 313 cases, 130 consecutive cases were identified in the Background: For decades, oto-surgeons have been trying to find suitable
first period and 65 in the second time period. One hundred two patients alloplastic materials for replacing ossicles in the case of morphological and
had adequate follow-up for published guidelines. All cases were per- functional disorders in the middle ear. The focus of attention has been on
formed by the senior author (c.g.j.). Comparison data were obtained tissue tolerance and functionality.
from a previous publication involving the senior author.
Patients: A retrospective analysis of the implantation of titanium prostheses
Results: Successful rehabilitation (≤ 20 dB pure-tone average air-bone gap) is presented (Type "Duesseldorf", Heinz Kurz GmbH, Dusslingen, Germa-
of conductive hearing loss was obtained in 70% of partial ossicular chain ny) in 528 patients operated in 14 ENT hospitals. The hospitals involved
reconstructions and 44% of total ossicular chain reconstructions when tita- are ENT hospitals with different fields of specialization presenting a repre-
nium prostheses were used. Comparison data revealed successful rehabili- sentative cross-section of surgical ENT treatment. Evaluated were healing
tation in 48% and 21% of non-titanium-based partial and total reconstruc- results, hearing gain and surgical handling of the implants.
tions, respectively. Postoperative pure-tone average air-bone gaps were not
significantly different when compared with results in the period from July Results: Despite pathological middle ear conditions, the tissue-implant
2002 to February 2003. healing rate was very high. In 4.4% of the patients the implants were reject-
ed. In the case of partial ossicular reconstruction, an average hearing gain
Conclusion: Newer titanium-based ossicular reconstruction devices rep- between 10 and 20 dB was achieved. Total reconstruction of the ossicular
resent an improvement over previously used non-titanium-based prosthe- chain showed even better audiological results (15 to 20 dB on average).
ses. The authors think that this improvement is realized rapidly because no
learning curve existed in their data. Conclusion: Due to the good morphological and functional results achieved,
titanium implants have proven their worth for middle ear micro-surgery.
Their advantages are their light weight and delicate structure, facilitating
Preliminary Ossiculoplasty Results using the Kurz Titanium very good micro-surgical handling. It is advisable to place a thin layer of
Prostheses cartilage between the prosthesis headplate and the tympanic membrane. In
this manner, the number of material extrusions can be safely reduced, how-
Krueger W. W., Feghali J. G., Shelton C., Green J. D., Beatty ever, extrusions cannot completely be avoided.
C.W., Wilson D. F., Thedinger B. S., Barrs D. M., McElveen J. T.

Published: Otology & Neurotology 23: 836-839 (2002) Replacement of ear ossicles with titanium prostheses
DOI: 10.1097/00129492-200211000-00004
Stupp C. H., Stupp H. F., Grün D.
Objective: Limitations in biocompatibility and hearing improvement with
ossicular chain reconstruction prostheses are addressed with new, light- Published: Laryngorhinootologie. 1996 Jun;75(6):335-7. (German)
weight titanium prostheses designed to maximize visualization of the ca- DOI: 10.1055/s-2007-997590
pitulum and footplate regions. The effectiveness of these new prostheses is
being tested in a prospective multicenter study. Background: Titanium has been a well established implant material for
many years. New material processing techniques now permit the manufac-
Study Design: Prospective case series. Setting: Multicenter (8 sites), pri- ture of small implants for ossicular chain reconstruction.
marily tertiary private practice or academic otologic clinics.
Methods: Between November 1994 and September 1995, 100 titanium
Patients: A convenience sample of 31 patients undergoing ossiculoplasty, middle ear implants (55 PORP, 45 TORP) were used for reconstruction of
with 16 partial ossicular chain reconstructions using the Bell prosthesis and the ossicular chain. A range of five different sizes for partial and total proth-
15 total reconstructions using the Aerial prosthesis. eses suits all implantation needs. The shape of the implants can be altered by
bending. Time consuming intraoperative shaping and trimming is avoided.
Intervention: Ossiculoplasty using new Kurz titanium prostheses.
Cartilage was interposed between the tympanic membrane and the Results: At a follow-up time of three months (33 patients) and six months
prosthesis. (17 patients), no adverse reactions or extrusions occurred. Biologic fixation
between the foot of the partial prothesis and the head of the stapes was
Main Outcome Measures: Air-bone gap for pure tone average and 3,000 found eight months after implantation. A hearing result of 0-20 dB residual
and 4,000 Hz, assessed preoperatively and 3 months, 6 months, and 12 air-bone gap was achieved in 79%.
months postoperatively; percent of patients obtaining an air-bone gap of
≤ 20 dB; high-frequency average (1,000, 2,000, and 4,000 Hz) to evaluate Conclusion: Titanium middle ear implants show good bio-compatibility and
sensorineural hearing loss; and extrusion rate. are readily integrated into the ossicular chain. Although delicate in shape, they
offer excellent mechanical properties in respect to sound conduction and im-
Results: A postoperative air-bone gap of </=20 dB was obtained in 81% of plantation. Initial results show Titanium to be a perfect implant material
Bell prosthesis patients and 67% of Aerial prosthesis patients at 3 months. for middle ear prostheses, although long-term results are not yet available.
The results were stable to improved for later time intervals. High-frequen-
cy gaps were similar to the pure tone average gap. To date, there have
been no instances of extrusion, and all the surgeons found the prostheses Three years experience with titanium implants in the middle ear
easy to use and thought that the design characteristics facilitated accurate
placement. Stupp C. H., Dalchow C., Grün D., Stupp H. F., Wustrow J.

Conclusions: Initial evaluation of the Kurz titanium prostheses produced Published: Laryngorhinootologie 1999 Jun;78(6):299-303. (German)
low extrusion rates (none to date) with excellent hearing results, including DOI: 10.1055/s-2007-996875
good high-frequency conduction. Good visualization and accurate place-
ment were easy to achieve. Further studies are needed to confirm long-term Background: In continuation of our previously published report on initial
efficacy. experience with titanium implants in the middle ear [13], we now present

8
the results of routine use over a three year period. designed to sit under the tympanic membrane. Previously, the author had
designed titanium prostheses with a malleus notch extension at the head
Methods: From November 1994 to November 1997, 661 titanium implants plate. The present study aimed to assess whether these customised prosthe-
(Dusseldorf model) were implanted in the authors’ clinics (355 PORP, 306 ses were user-friendly, compared with conventional prostheses. Fourteen
TORP). There was no preselection of patients. Five hundred eighty-two follow surgeons were recruited to examine the user-friendliness of several ossicu-
up examinations were performed with a medium follow up time of 11.6 months. lar prostheses. They performed ossiculoplasties on temporal bones and rat-
ed the user-friendliness of the malleus notch prosthesis against that of some
Results: The good initial results of the previous study with respect to bio- of the more popular conventional ossicular prostheses. For malleus-stapes
compatibility and functional hearing results were confirmed in the long assembly, eight out of 13 surgeons preferred the malleus notch prosthesis
term follow-up. The average air-bone gap was calculated over the frequen- to the Düsseldorf and Goldenberg designs. For malleus-footplate assembly,
cies 0.5, 1, 2, and 4 kHz. Closure to within 20 dB was achieved in 72% six out of 10 surgeons preferred the malleus notch prosthesis to the Düssel-
of cases. The air-bone gap tended to decrease with increasing time of im- dorf and Richards designs. Most of the surgeons stated that the reconstruc-
plantation. Adverse reaction to the prostheses did not occur. Extrusion oc- tion was more stable using the malleus notch prosthesis.
curred in one case of complete middle ear atelectasis with resorption of the
interposed cartilage. Insufficient improvement of hearing was attributable
to a short implant in 12 cases (1.8%). In three cases (0.5%) insufficient sta- OMEGA CONNECTOR
bility of the PORP was attributable to eroded stapes suprastructure, and in
three others (0.5%) a dislocation was responsible for a poor hearing result.
Middle ear fibrosis with impairment of sound transmission was seen in 3 Results of chain reconstruction with missing stapes
patients (0.5%). superstructure using a jointed coupling module
(Omega connector) with titanium total prostheses
Conclusion: The superior acoustic properties of the delicate yet rigid low-
weight titanium implants combined with excellent biocompatibility lead to Fischer M.
a good hearing result if a meticulous surgical technique is employed. The
easy handling makes it a pleasure to work with these protheses. Published: German Society for Oto-, Rhino-, Laryngology, Head and Neck
Surgery. 86th Annual Meeting of the German Society for Oto-, Rhino-, Lar-
yngology, Head and Neck Surgery e.V. Berlin, May 13-16, 2015. Düssel-
dorf: German Medical Science GMS Publishing House; 2015. March 26,
MNP MALLEUS NOTCH PROSTHESIS 2015. Poster Abstract (German) DOI: 10.3205/15hnod336

Introduction: The Omega connector, a jointed coupling module for chain

reconstruction with missing stapes superstructure, has been available for
An Optimal Partial Ossicular Prosthesis Should Connect some years. The literature contains only two studies reporting the results of
Both to the Tympanic Membrane and Malleus: the implantation with 14 and 17 patients.
A Temporal Bone Study Using Laser Doppler Vibrometry
Methods: Retrospective evaluation of audiological results with 56 consec-
Niklasson A., Gladiné K., Rönnblom A., von Unge M., utive operations conducted by the author using the Omega connector. The
Dirckx, J., Tano K. Omega connector has always been placed where it could be securely posi-
tioned on the footplate when used with chain reconstruction in the presence
Published: Otology & Neurotology: 03/ 2018 - vol 39 - Issue 3 - p 333–339 of a defect of the stapes superstructure.
DOI: 10.1097/MAO.0000000000001699
Results: 56 operations using the Omega connector have been registered
Objective: To compare stapes vibrations in different partial ossicular since 2009. The data of preoperative and postoperative audiograms for 48
replacement prosthesis (PORP) applications. patients were available for analysis. They covered mostly male patients
(68%) and left ears (62%). The preoperative conductive hearing loss (air-
Methods: Stapedial vibrations were measured on fresh frozen human tem- bone-gap, average of distances between air and bone conduction threshold
poral bones with laser Doppler vibrometry. Eight different types of common at 500 Hz, 1kHz, 2 kHz and 3 kHz) was on average (SD) 35.36 dB (13.24),
ossiculoplasty methods were compared regarding recovery of stapes vibra- after the operation the residual conductive hearing loss was on average
tions in relation with the normal ossicular chain. The PORPs were divided 24.54 dB (8.67). 41.67% of patients reach the „criterion for success“ of a
into three groups: 1) PORPs with the lateral contact only with the tympanic residual conductive hearing loss of a maximum of 20 dB. The postoperative
membrane, 2) PORPs with lateral contact only to the malleus handle, and 3) results were analyzed with reference to different influence factors.
PORPs with lateral contact with both the malleus handle and the tympanic
membrane. Conclusions: The Omega connector in combination with titanium total
prostheses shows promising results, even in the absence of stapes super-
Results: The PORPs with lateral contact only to the malleus handle per- structure. Ventilation malfunctions are often the cause of lack of success. A
formed better than the PORPs with lateral contact to the tympanic mem- two-stage procedure should be considered in the case of CWD operations
brane only at 2 kHZ, but the best recovery was found in the group with with cholesteatoma.
contact both to the malleus handle and the tympanic membrane.

Conclusion: The best sound transmission might be achieved by placing a Ossiculoplasty with Total Ossicular Replacement
PORP in contact with both the tympanic membrane and the handle of the Prosthesis and Omega connector: Early Clinical Results
malleus. and Functional Measurements

Mantei T., Chatzimichalis M., Sim J. H., Schrepfer T.,

Titanium prosthesis with malleus notch: Vorburger M., Huber A. M.
a study of its “user-friendiness”
Published: Otology & Neurotology 09/2011: 32(7):1102-7
Yung M. DOI: 10.1097/MAO.0b013e3182267e3b

Published: The Journal of Laryngology & Otology (2007), 121,938-942. Objective: Among other difficulties, achieving a stable position of a total
DOI: 10.1017/S0022215107005944 ossicular replacement prosthesis (TORP) is demanding because of a lim-
ited view on the TORP-footplate interface and individual angles between
‘‘User-friendliness’’ is an important factor in the choice of ossicular pros- the footplate and tympanic membrane. The Kurz Omega Connector aims
thesis. The current titanium prostheses have a flat, open head plate and are at a simplified insertion of the TORP. The performance of total ossicular

9
reconstruction using the Omega Connector was evaluated. Vincent R., Bittermann A. J. N., Wenzel G. Oates J., Sperling
N., Lenarz T., Grolman W.
Study Design: Prospective cohort study and experimental measurements
with a fresh human temporal bone. Setting: Tertiary referral center. Published: Otol Neurotol. 2013; 34 (1): 83-90
DOI: 10.1097/MAO.0b013e318277a2bd
Patients: Seventeen consecutive patients receiving total ossicular recon-
struction were included. Historical control group composed of 36 patients. Objectives: To present the preliminary results of new malleus replacement
Interventions: Total ossicular reconstruction using the Omega Connector. prosthesis combined with a total ossicular prosthesis in middle ear recon-
struction in patients missing the malleus and stapes.
Main outcome Measures: (a) Handling of the TORP and Omega Con-
nector intraoperatively, (b) functional short-term results compared with a Study Design: Prospective experimental and nonrandomized clinical
historical control group, (c) sound transmission properties with 3 different study. Setting: Tertiary referral center.
connective positions between the TORP and the Omega Connector.
Methods: An original titanium malleus replacement prosthesis (MRP) was
Results: Placing the Omega Connector on the footplate and coupling the designed to be inserted into the external auditory canal and to replace a
Omega Connector to the TORP was straightforward in 65% of cases. A missing malleus for various middle ear pathologies. The MRP was tested
stable final position of the TORP was obtained in 88% of cases. Mean (SD) experimentally and clinically. The vibratory properties of the new prosthe-
preoperative and postoperative air-bone gaps were 36.00 (11.05) and 25.29 sis were measured using laser Doppler vibrometry. Ninety patients with
(12.25) dB and were almost identical with those in the historical control group missing malleus and stapes, undergoing 92 ossicular reconstructions were
(p = 0.9). In the experimental measurements, functional outcomes with enrolled in this study from September 1994 to March 2012. Comparative
"partial connection" showed almost the same results as those with "full analyses were made between a group of 34 cases of ossicular reconstruc-
connection." tions with total prosthesis (TORP) positioned from the tympanic mem-
brane to the stapes footplate (TM-to-footplate assembly) and a group of
Conclusions: The Omega Connector provides easy handling of the TORP. 58 cases of ossicular reconstructions with TORP positioned from a newly
The short-term functional results were comparable to those achieved pre- designed malleus replacement prosthesis (MRP) to the stapes footplate
viously without the Omega Connector. The temporal bone measurement (MRP-to-footplate assembly). Preoperative and postoperative audiometric
supports tolerance in connective position between the TORP and the evaluation using conventional audiometry, that is, air-bone gap (ABG),
Omega Connector. bone-conduction thresholds (BC), and air-conduction thresholds (AC)
were assessed.

The Ω Connector - A Module for Jointed Coupling of Results: Experimentally, the vibratory properties of the MRP are promising
Titanium Total Prostheses in the Middle Ear and remain very good even when the MRP is cemented into the bony canal
wall mimicking its complete osseous-integration, if this were to occur. This
Schmid G., Steinhardt U., Heckmann W. finding supports the short-term clinical results as in the TM-to-footplate
group; the 3-month postoperative mean ABG was 23.3 dB compared with
Published: Laryngo-Rhino-Otologie 2009, vol. 88, no (12), pp. 782-788 12.5 dB in the MRP-to-footplate group (difference, 10.8; 95% confidence
DOI: 10.1055/s-0029-1231047 interval, 4.0 - 17.6); 37.0% of patients from the TM-to-footplate group had
a postoperative ABG of 10 dB or less, and 48.1% of patients had a postop-
Background: Hearing improvement after reconstruction of a defect os- erative ABG of 20 dB or less, as compared with 58.1% and 79.1%, respec-
sicular chain depends on material, design and - crucially - coupling of the tively, in the MRP-to-footplate group. The average gain in AC was 11.0 dB
prosthesis. Coupling a total ossicular replacement prosthesis to the stapes in the TM-to-footplate group as compared with 21.3 dB in the MRP-to-
footplate can be problematic and lead to prosthesis instability. In order to footplate group (difference, -10.3; 95% confidence interval, -18.2 to - 2.4).
solve this problem, the Ω Connector was developed, a module allowing
the middle ear surgeon to couple a titanium total prosthesis to the stapes Conclusion: The results of this study indicate that superior postoperative
footplate in a flexible, angle-variable manner. hearing thresholds could be achieved using a MRP-to-footplate assem-
bly, compared with a TM-to-footplate assembly in patients with an absent
Material and Method: The Ω Connector is made of pure titanium and malleus undergoing ossiculoplasty. The postoperative AC thresholds, after
consists of three components: head, neck and base plate. The head allows 3 months and 1 year, are significantly lower in patients treated with the
a jointed coupling to the steam of a titanium total prosthesis. Positioned MRP-to-footplate assembly.
between the remnants of the stapes crura, the bas plate proves for a stable
connection with the stapes footplate.

Results: The Ω Connector was implanted during 14 revisions surgeries. In C L I P PA R T I A L F L E X I B A L

10 of these surgeries a total ossicular replacement prosthesis was removed
which was implanted at an earlier date and which was fixed and no longer
functioning. In all 14 cases it was possible intraoperatively to position the Ω Long-term hearing results and patient satisfaction after
Connector correctly and to couple it to a titanium total prosthesis. The post- tympanoplasty with Titanium-CliP Prostheses
operative hearing gain was between 10 to 25 dB, with an average of 18 dB.
Wolferts G., Schicke D., Delank K.W.
Conclusion: For the first time, the Ω Connector offers to the surgeon the
option to couple a titanium total prosthesis via a micro ball joint. Hearing Published: 86th Annual Meeting of the German Society for Oto-, Rhino-,
results achieved so far are satisfying. The results confirm the advantages of Laryngology, Head and Neck Surgery. Berlin, May 13-16, 2015. Düsseldorf:
the Ω Connector during implantation of a titanium total prosthesis. For a German Medical Science GMS Publishing House; 2015. Doc15hnod526,
final evaluation, long-term studies have yet to be made. March 26, 2015. Poster Abstract (German). DOI: 10.3205/15hnod526

Introduction: Titanium-CliP® Prostheses (Dresden or FlexiBal® type,

Kurz) have been in use for reconstruction of the ossicle chain for several
MRP MALLEUS REPLACEMENT PROSTHESIS years. So far only a few studies of the long-term audiological and otologi-
cal results have been published. The quality of life of patients has not been
analyzed.
Ossiculoplasty in Missing Malleus and
Stapes Patients: Experimental and Preliminary Clinical Methods: From 2003-2013 140 patients received a tympanoplasty with im-
Results With a New Malleus Replacement Prosthesis With the plantation of a Titanium-CliP® Prosthesis in this hospital. We conducted a
Otology-Neurotology Database retrospective, monocentric study with prospective follow-up of up to eleven

10
years after the initial procedure. Otological microscope findings and audio- Objective: To describe a new titanium clip prosthesis for partial ossicular
logical measurement data were evaluated for the analysis. The quality of life reconstruction with a micro ball joint in the headplate for compensation of
was evaluated based on the Glasgow Benefit Inventory. The objective of the tympanic membrane displacements.
study was to find information on the long-term hearing results (air-bone gap
before and after operation), the seating of the prosthesis, the rate of revision Patients: Laboratory experiments followed by 18 consecutive patients.
operations, protrusions and extrusions, and patient satisfaction.
Interventions: A micro ball joint was implemented into a headplate of ti-
Results: 30 patients were recruited and the average follow-up was 64 tanium middle ear prosthesis. First, the new prosthesis was tested in the
months. The validated analysis of quality of life showed an improvement; laboratory in temporal bone experiments. Second, the new prosthesis was
protrusions or extrusions were documented in isolated cases. The sound clinically installed in 18 patients.
transmission component - measured over frequencies 0.5-4 kHz - was re-
duced pantonally from an average of 21 dB to 10.2 dB. Outcome Measures: Results of laser Doppler vibrometry and force mea-
surements in the laboratory experiments, analysis of a questionnaire, and
Conclusion: This study demonstrates that the results remain stable over preoperative and postoperative pure tone audiometry.
the long term and in contrast to other methods of chain reconstruction the
sound conduction component is reliably reduced. This was also the first Results: The frictional resistance in the joint was measured to be 12 mN
time that a validated measurement procedure could be used to show that that should allow for adequate mobility under physiologic conditions. The
the subjective quality of life of patients is positively affected over the long effective sound transmission of the prosthesis was demonstrated by laser
term. Reconstruction of the ossicle chain with titanium CliP® Prostheses Doppler vibrometry. Intraoperatively, the installation of the prosthesis was
is now an established procedure. always straightforward with headplate prosthesis shaft angles between 60
and 90 degrees. Postoperatively, pure tone audiometry revealed satisfying
hearing results with a remaining average air-bone gap of 18.2 dB over the
Experience With the Use of a Partial frequencies 500, 1,000, 2,000, and 3,000 Hz. No signs of prosthesis disloca-
Ossicular Replacement Prosthesis With a Ball-and-Socket tion were discovered within the follow-up period of approximately 6 months.
Joint Between the Plate and the Shaft
Conclusion: The experimental data show that the new modified prosthesis
Birk S., Brase C., Hornung J. headplate fulfills the requirements necessary for sound transmission. The
joint allows the plate to follow movements of the tympanic membrane. This
Published: Otol Neurotol 2014; 35(7) :1248-1250 characteristic in conjunction with the proven clip design ensure for optimal
DOI: 10.1097/MAO.0000000000000383 prosthesis placement and effectiveness.

Background: In the further development of alloplastic prostheses for use in

middle ear surgery, the Dresden and Cologne University Hospitals, working
together with a company, introduced a new partial ossicular replacement C L I P PA R T I A L P R O S T H E S I S D R E S D E N T Y P E
prosthesis in 2011. The ball-and-socket joint between the prosthesis and the
shaft mimics the natural articulations between the malleus and incus and be-
tween the incus and stapes, allowing reaction to movements of the tympanic Short and Long-Term Outcomes of Titanium Clip Ossiculoplasty
membrane graft, particularly during the healing process.
Kahue Ch. N., O’Connnell B. P., Dedmon M. M.,
Study Design: Retrospective evaluation Haynes D. S., Rivas A.

Methods: To reconstruct sound conduction as part of a type III tym- Published: Otolo Neurotol 2018; 39(6): e453-e460
panoplasty, partial ossicular replacement prosthesis with a ball-and-socket DOI: 10.1097/MAO.0000000000001795
joint between the plate and the shaft was implanted in 60 patients, with
other standard partial ossicular replacement prosthesis implanted in 40 Objective: To report short (~4 mo) and long-term (>12 mo) audiometric
patients and 64 patients. Pure-tone audiometry was carried out, on av- outcomes following ossiculoplasty using a titanium clip partial ossicular
erage, 19 and 213 days after surgery. Results of the partial ossicular reconstruction prosthesis.
replacement prosthesis with a ball-and-socket joint between the plate
and the shaft were compared with those of the standard prostheses. Methods: Case series at a single tertiary referral center reviewing 130 pe-
diatric and adult patients with conductive hearing loss (CHL) secondary to
Results: Early measurements showed a mean improvement of 3.3 dB in the chronic otitis media (n = 121, 93%) or traumatic ossicular disruption (n = 9,
air-bone gap (ABG) with the partial ossicular replacement prosthesis with a 7%) who underwent partial ossiculoplasty from January 2005 to December
ball-and-socket joint between the plate and the shaft, giving similar results 2015 with the CliP prosthesis.
than the standard implants (6.6 and 6.0 dB, respectively), but the differences
were not statistically significant. Later measurements showed a statistically Results: At both short and long-term follow-up, postoperative air-bone
significant improvement in the mean ABG, 11.5 dB, compared with 4.4 dB gap (ABG) was significantly improved (18 dB HL, IQ range 13–26,
for one of the standard partial ossicular replacement prosthesis and a ten- p < 0.0001 and 18 dB HL, IQ range 13–29, p = 0.0002, respectively)
dency of better results to 6.9 dB of the other standard prosthesis. when compared with preoperative values (29 dB HL, IQ range 19–37). No
significant change in ABG was noted when comparing short and long-term
Conclusions: In our patients, we achieved similarly good audiometric intervals (18 versus 18 dB HL, p = 0.44). Fifty seven percent of cases
results to those already published for the partial ossicular replacement (51/89) achieved a long-term ABG less than or equal to 20 dB at the time
prosthesis with a ball-and-socket joint between the plate and the shaft. of their last follow-up. The extrusion and displacement rates were 1.5%
Intraoperative fixation posed no problems, and the postoperative com- (2/130), and 0.8% (1/130), respectively. There were no cases of iatrogenic
plication rate was low. sensorineural hearing loss.

Conclusions: Partial ossiculoplasty with the titanium CliP produces good

Titanium Clip Ball Joint: hearing outcomes with a favorable safety profile. At long-term follow-up
A Partial Ossicular Reconstruction Prosthesis (minimum of 12 mo), median ABG was 18 dB and remained stable when
compared with short-term follow-up. The majority of patients had success-
Beutner D., Luers J. C., Bornitz M., Zahnert T., ful long-term results, with 57% of patients achieving an ABG is less than or
Hüttenbrink K.-B. equal to 20 dB. Low rates of extrusion (1.5%) and prosthesis displacement
off the stapes (0.8%) support the long-term stability of the CliP prosthesis
Published: Otol Neurotol. 2011; 32 (4) : 646-9 in the middle ear.
DOI: 10.1097/MAO.0b013e318213867a

11
Coupling problems in middle ear reconstruction Conclusion: This study demonstrates that the results remain stable over
the long term and in contrast to other methods of chain reconstruction the
Zahnert T. sound conduction component is reliably reduced. This was also the first
time that a validated measurement procedure could be used to show that the
Published: MEMRO 2006, 4th International Symposium on Middle Ear subjective quality of life of patients is positively affected over the long term.
Mechanics in Research and Otology: Selected Abstracts. Reconstruction of the ossicle chain with Titanium-CliP® Prostheses is now
an established procedure.
The normal and reconstructed middle ear can be considered as a mechani-
cal vibrating system. After the implementation of tympanoplasty as a stan-
dardized surgical technique various reconstruction techniques and implants Titanium CliP Prosthesis
were suggested for the reconstruction of the tympanic membrane and the
ossicular chain. Laser–Doppler-vibrometry and model calculations have Hüttenbrink K.-B., Zahnert T., Wüstenberg E.G., Hofmann G.
given new insight into the vibration modes of the normal and reconstruct-
ed middle ear during the recent years. Nowadays it can be concluded, that Published: Otology & Neurotology 25:436-42 (2004)
not only material properties of implants but also coupling factors have an
important influence on good hearing results. We investigated coupling fac- Objective: Prostheses for the reconstruction of a defective ossicular chain
tors between tympanic membrane and the surrounding bone, between the should be stable and firmly anchored to the ossicular remnants. This will
tympanic membrane and middle ear implants and between the prosthesis prevent a defective connection from causing diminished sound transmission
and the ossicular chain using model calculations and temporal bone exper- efficiency and will keep the prosthesis from tilting or even losing contact,
iments. The quality of the tympanic membrane, which can be considered which would result in a sound transmission block. Through temporal bone
as the “motor of the middle ear”, has the most important impact on the experimentation, we have consequently developed a very lightweight titani-
sound transfer to the inner ear. Ventilation and mucosa problems can damp um prosthesis, which is fastened onto the stapes head with a clip mechanism.
the tympanic membrane vibrations as well as the reconstruction techniques
or the mechanical properties of transplants. The coupling of the tympanic Methods: When temporal bone experiments using laser Doppler vibrometry
membrane to either the surrounding bone or the cartilage transplants has confirmed that the prosthesis functioned well acoustically and when luxation
an influence on the stiffness. The contact of the tympanic membrane to the experiments proved that it could be safely used without the risk of stapes
malleus handle is of importance in order to allow good sound conduction dislocation, the prosthesis was used in a clinical application within an obser-
to middle ear prostheses in the high frequency range. Furthermore the con- vational study. The University of Dresden Otorhinolaryngological Hospital
tact of prostheses to the stapes head or the footplate may influence hearing as well as seven surgeons from five other hospitals participated in the study.
results. In our investigations the angle of prostheses towards the tympanic
membrane and the stiffness of coupling plays an important role. Concerning Results: The results of 133 operations showed that, in over 90% of the
the angle it is of importance to distinguish between the x and y – direction. cases, the prosthesis could be implemented without problems and with good
An absolutely stiff contact between malleus and stapes can reduce the sound mechanical stability. The first acoustical results obtained during the first
transfer and increase the risk of prosthesis dislocation or even damage of year from 49 patients showed a sound transmission improvement range
the annular ligament. Even nowadays modern middle ear reconstructions from 12 dB to 14 dB.
can only simulate the simple function of a columella. In future it may be
important to invent middle ear implants which will be able to fulfil both Conclusion: With the clip prosthesis, it seems possible to further improve
required middle ear functions – the sound transfer and the compensation of defective middle ear function, which would allow the patient to regain so-
atmospheric pressure changes. It can be assumed that hearing results may cial hearing after middle ear reconstruction. The reliability of the fasten-
improve due to an unstressed coupling of middle ear prostheses by taking ing is an innovation. Revision operations showed a stable prosthesis-stapes
the above mentioned techniques and findings into consideration. complex in the middle of a recurring cholesteatoma and the prosthesis could
always be easily pulled from the stapedial suprastructure.

Long-term hearing results and patient satisfaction after

tympanoplasty with Titanium-CliP Prostheses

Wolferts G., Schicke D., Delank K.W. ANGULAR CLIP PROSTHESIS

Published: 86th Annual Meeting of the German Society for Oto-, Rhino-,
Laryngology, Head and Neck Surgery. Berlin, May 13-16, 2015. Düssel- Titanium Angular Clip: A New Prosthesis for
dorf: German Medical Science GMS Publishing House; 2015. Doc15h- Reconstruction of the Long Process of the Incus
nod526, March 26, 2015. Poster Abstract (German)
DOI: 10.3205/15hnod526 Hüttenbrink K.-B., Luers J.C., Beutner D.

Introduction: Titanium-CliP® Prostheses (Dresden or FlexiBal® type, Kurz) Published: Otology & Neurotology 30(8):1186-1190, December 2009
have been in use for reconstruction of the ossicle chain for several years. So DOI: 10.1097/MAO.0b013e3181b287f2
far only a few studies of the long-term audiological and otological results
have been published. The quality of life of patients has not been analyzed. Objective: To describe a new titanium angular clip prosthesis for bridging
the incudostapedial joint in the event of an isolated lesion of the distal end
Methods: From 2003-2013 140 patients received a tympanoplasty with im- of the long process of the incus.
plantation of a Titanium-CliP® Prosthesis in this hospital. We conducted a
retrospective, monocentric study with prospective follow-up of up to eleven Study Design: Clinical retrospective study.
years after the initial procedure. Otological microscope findings and audio-
logical measurement data were evaluated for the analysis. The quality of life Methods: We retrospectively reviewed the course of 22 patients with iso-
was evaluated based on the Glasgow Benefit Inventory. The objective of the lated defects of the long process of the incus where the ossicular chain was
study was to find information on the long-term hearing results (air-bone gap reconstructed by a titanium angular clip prosthesis.
before and after operation), the seating of the prosthesis, the rate of revision
operations, protrusions and extrusions, and patient satisfaction. Results: The placement of the prosthesis was successful in all patients,
and no complication was encountered during its installation. At the first
Results: 30 patients were recruited and the average follow-up was 64 months. follow-up visit after 3 weeks, the mean air-bone gap (ABG) was reduced
The validated analysis of quality of life showed an improvement; protru- by around 10 dB from a mean of 26 dB preoperatively to 16 dB postop-
sions or extrusions were documented in isolated cases. The sound trans- eratively. The mean postoperative hearing result of patients with a Type A
mission component - measured over frequencies 0.5-4 kHz - was reduced tympanogram (7-dB ABG) was consistently better than for patients with a
pantonally from an average of 21 dB to 10.2 dB. Type B or a Type C tympanogram (19-dB ABG in both).

12
Conclusion: Despite the limited number of patients, this preliminary study Conclusion: When considering the limited experience, the NiTiFLEX Sta-
demonstrates the effectiveness of the angular clip prosthesis in recon- pes Prosthesis is a promising development of the (Soft) Clip technique. The
structing the ossicular chain. In cases of a normal aeration of the tympanic audiological results of the small series of cases are very satisfactory and
cavity, this reliable reconstruction of the biological chain offers a near-to- comparable with other prostheses. However, long-term results with a great-
normal hearing restoration. er number of cases are still necessary.

Initial experience with the NiTiFLEX® Stapes Prosthesis

R E G E N S B U R G T Y P E T O TA L P R O S T H E S I S at the ENT Hospital Erlangen

Brase C., Pohmer S., Stockmayer N., lro H., Hornung J.

A Micro-Computed Tomographic Study: Determination of the
Angle Between the Tympanic Membrane and Stapes Footplate Published: 86th Annual Meeting of the German Society for Oto- Rhino-
in a Total Ossicular Reconstruction Prosthesis Reconstruction Laryngology, Head and Neck Surgery. Berlin, May 13-16, 2015. (German)
DOI: 10.3205/15hnod316
Herkenhoff S., Fischer B., Gleich O., Strutz J., Kwok P.
Introduction: One of the most important steps in stapes surgery is fixing
Published: Otol Neurotol. 2011 Jun;32(4):610-5. the stapes prosthesis to the long process of the incus. In recent times great
DOI: 10.1097/MAO.0b013e318213af4d efforts have been made to simplify this step with “self-fixing” prostheses.
This paper reports on our initial experience with the Kurz NiTiFLEX Stapes
Objectives: To examine the anatomical relationship of the angles between Prosthesis.
tympanic membrane and stapes footplate and the variation of these angles
among different temporal bones in order to characterize the optimal shape Material and Methods: A total of 16 NiTiFLEX prostheses was implanted
of total ossicular reconstruction prostheses (TORPs). between 8/2014 and 11/2014. All operations were performed under full an-
esthesia. The preoperative air-bone gap at 0.5, 1, 2 and 4 kHz was compared
Methods: Ten specimens of human temporal bones were prepared for with the postoperative air-bone gap after an average of one month and after
examination with microcomputed tomography. Five of the 10 temporal about 3 months.
bones were implanted with 3 types of TORPs before subjecting them to
micro-computed mography. The angles between tympanic membrane Results: During the operation it was shown that the prosthesis was not well
and stapes footplate were determined. The contact of the TORPs to these attached to all processes of the incus. In three cases the prosthesis could
structures was assessed. not be fixed during the operation due to the thickness of the process of the
incus and had to be removed. The audiological results for the patients in
Results: The angle between the stapes footplate and the tympanic mem- whom the prosthesis could be fixed were comparable with those of other
brane was, on average, 25.9 degrees in a plane along the transverse axis of self-fixing prostheses.
the stapes footplate and 24.6 degrees in a plane along the longitudinal axis
of the stapes footplate. Consideration of these angles in TORPs resulted in Conclusion: The NiTiFLEX Stapes Prosthesis can be fixed without diffi-
an optimal contact with the tympanic membrane and stapes footplate, espe- culties to normally shaped processes of the incus and yields good postop-
cially for theses with a large foot. erative audiological results. As a development of the well-known SoftClip
prosthesis with superelastic material, the NiTiFLEX prosthesis should be
Conclusion: TORPs should be adjusted in shape before insertion into the suitable for a wide range of processes of the incus. However, due to the
middle ear. Further developments should consider prostheses with pread- relatively small prosthesis eyelet, it cannot be used for every anatomical
justed angles or appliances for the exact modification of the prostheses variation of the long process of the incus.
during surgery.

M AT R I X
NITIFLEX

Initial experiences with the Matrix Type Stapes Prosthesis

Initial experience with the NiTiFLEX® Stapes Prosthesis
Rösch S., Moser G., Töth M., Rasp G.
Zirkler J., Rahne T., Plontke S.
Published: Austrian Annual Meeting of ENT, 2015. Poster Abstract (German)
Published: 86th Annual Meeting of the German Society for Oto-, Rhino-, Lar- DOI:10.1097/MAO. 0b013e3182a43619
yngology, Head and Neck Surgery. Berlin, May 13-16, 2015. Poster Abstract
(German) DOI: 10.3205/15hnod534 Introduction and Question: A new prosthesis joined the wide range of
prostheses available for stapedioplasty about two years ago, the Kurz Matrix
Introduction: The attachment to the long process of the incus is the most Type. This report describes our initial experience with this prosthesis with the
important part of stapes surgery. We report here on our initial experience postoperative audiology results and the handling during the operation.
with the new NiTiFLEX Stapes Prosthesis, a development of the Soft
CliP® Stapes Prosthesis (Kurz). The clip is now made of nitinol, a nickel- Method: Retrospective data analysis using the ENTstatistics Digital database.
titanium alloy. The contact pressure on the long process of the incus has
been further reduced and the attachment to the long process of the incus Results: A total of 22 patients received the Kurz Matrix Type Stapes Pros-
should be simplified. theses on one side (n=22) during a primary stapes operation from Septem-
ber 2014 to May 2015. A test of the 0.5, 1.0, 2.0 and 4.0 kHz frequencies
Method: A stapedioplasty was done in 11 patients (6f, 5m) (a revision showed an average improvement of the air-bone gap of approximately
operation).The average age of the patients was 45 years. The footplate was 15 dB. The postoperative follow-up for all patients was less than 12 months.
perforated by a CO2 laser (scanning mode).
Discussion/ Conclusion: The initial analysis of the experience with the
Results: The NiTiFLEX Stapes Prosthesis could be placed in all patients Matrix Type Stapes Prosthesis at our hospital appears to lead to good results
without complications. There was no significant change in bone conduc- in improving hearing. In particular, the handling of the prosthesis during the
tion after the operation. The sound conduction gap could be satisfactorily operation is satisfactory for the surgeon. The new design of the loop with a
reduced in all patients. (4PTA 0.5-4 preoperative on average 23.6, postopera- wider and perforated surface and the spiral shape seems to improve the crimp-
tive 6.3 dB). We considered the handling of the prosthesis to be very good. ing procedure in particular and the subsequent seating of the prosthesis on

13
the long process of the incus. Now comparative studies with other types of rithm had to be developed to simulate acoustical stimulation using electro-
prostheses and a longer follow-up are required to assess the long-term results. mechanical stimulation.

Results: Optimal tight crimping of the stapes piston revealed consistent

good sound transfer function ranging from 0 to 7 dB loss, and loss re-
K- P I S T O N mained, on average, at 2 dB. The mean transmission losses for conditions
of loose crimping and no crimping were surprisingly small (within 10 dB).
However, these unusual crimping conditions allowed a wide range of losses
Diagnostic Findings in Stapes Revision Surgery- up to 28 dB. A close coupling at least at two opposite points was obligatory
A Retrospective of 26 Years to obtain consistently good results.

Schimanski G., Schimanski E., Berthold M.R. Conclusions: Perfect hearing reconstruction necessitates ideal crimping of
a prosthesis to obtain consistently good results. However, the final function-
Published: Otology & Neurotology: April 2011 - 32(3): 373-383. al gain depends on many different intraoperative and postoperative factors.
DOI: 10.1097/MAO.0b013e3182096da1

Objectives: The aim of the study is to obtain a detailed overview of the Retrospective analysis of early postoperative hearing
revision findings after stapes operations and to draw conclusions on a stapes results obtained after stapedotomy with implantation of a
prosthesis that can be recommended. new titanium stapes prosthesis

Study Design: Retrospective case series. Setting: Tertiary otologic referral Zuur C. L., de Bruijn A. J. G., Lindeboom R., Tange R. A.
center.
Published: Otology & Neurotology 24:863-867 (2003)
Methods: Approximately 12,000 middle ear operations within a period of
26 years were evaluated. The findings of the revisions were classified into Objective: To evaluate the early postoperative hearing results of a new
surgeon related, prosthesis related, and other causes. titanium stapes prosthesis (K-Piston) implanted in patients with otosclerosis.

Results: Three hundred forty-three stapes revisions were done. Many differ- Study Design: A retrospective analysis of preoperative and early postopera-
ent prostheses were found: the most common were Schuknecht prostheses tive hearing thresholds. Setting: One tertiary referral and teaching hospital.
and Teflon platinum, gold, and titanium pistons. Polyethylene strut, Teflon Patients: Eighteen men and 40 women, mean age 47 years, with otosclero-
wire pistons, Shea (Teflon) pistons, and other techniques, such as columel- sis. Intervention: Primary stapedotomy.
la or malleovestibulopexy, were rarely found. There are specific findings
correlating to certain prostheses: Schuknecht prostheses were too short in Main Outcome Measure: Main outcome measures were the mean gains
50% of the revisions (surgeon related), Teflon platinum caused necrosis or in bone-conduction and air-conduction pure-tone thresholds, and pure-tone
arrosion of the long incudal process (prostheses related) in 69%, and gold averages for different frequency combinations. Success and failure of the
caused reparative granuloma sometimes combined with necosis of the incus individual cases were presented using Amsterdam Hearing Evaluation Plots.
in 70% (prostheses related). There was no specific diagnostic finding with
titanium pistons, neither surgeon nor material related. Results: The overall postoperative air-bone gap for the frequency combi-
nation 0.5-1-2-4 kHz was 8.4 (standard deviation: 5.2) dB. In 79% of the
Conclusion: An analysis of revision findings over an extended observation patients the postoperative air-bone gap was less than 10 dB. Air-conduction
period can enable middle-ear surgeons to improve their surgical techniques improved even in higher frequencies, while the Carhart effect was not seen
and to select the best suited prosthesis. Self-fabricated stapes prostheses in most cases. In three patients a deterioration of bone-conduction was ob-
(e.g., Schuknecht) do not conform to required quality standards and should served ranging from 11 to 16 dB sound pressure level (SPL), and in four
not be used. GoPi, which is no longer available, and TPlPi showed prosthe- patients the gain in air-conduction was insufficient (3-29 dB SPL) to close
sis-related diagnostic findings. The titanium prostheses used by the authors the preoperative air-bone gap to within 20 dB.
have proven to be excellently compatible and can therefore be recommend-
ed as safe stapes prostheses. Conclusion: The new low-weight, full-titanium stapes prosthesis with its
slight rough surface and its good mechanical stability and biocompatibility
can safely and successfully restore the function of the middle ear when im-
Stapes Prosthesis Attachment: The effect of Crimping on planted in patients with otosclerosis.
Sound Transfer in Otosclerosis Surgery

Huber A. M., Ma F., Felix H., Linder T.

SOFT CLIP
Published: Laryngoscope 2003 May;113(5):853-8. Poster Abstract (German)
DOI: 10.1097/00005537-200305000-00015
Experimental study on admissible forces at the
Objectives/Hypothesis: Although in stapes surgery successful hearing incudomalleolar joint
improvement may be achieved in the majority of patients, unsatisfactory
closure of the air-bone gap can be recorded. One of many reasons for unex- Lauxmann M., Heckeler C., Beutner D., Lüers J. C.,
pected failures of stapes surgery may be the insufficient crimping of a stapes Huettenbrink K.-B., Chatzimichalis M., Huber A., Eiber A.
prosthesis onto the incus. The objectives of the study were to assess the
amount of sound transmission loss in response to the quality of prosthesis Published: Otol Neurotol. 2012 Aug;33(6):1077-84
crimping and to identify a required loop attachment pattern to obtain good DOI: 10.1097/MAO.0b013e318259b34b
sound transmission results.
Hypothesis: The forces that cause rupture of the incudomalleolar joint
Study Design: Experimental. during the fixation of stapedial prostheses can be determined by means of
load-deflection measurements at the long process of the incus. As in other
Methods: A temporal bone model was developed to measure the sound tissues, 3 ranges of forces can be defined: micro rupture, rupture, and short-
transmission properties between incus and prosthesis on 17 fresh human term maximum.
temporal bones. The attachment of a titanium stapes piston was assessed
without crimping, followed by loose crimping and tight fixation to the Background: A crucial step in stapes surgery is the attachment of the stape-
incus, using scanning laser Doppler interferometry, endoscopic photogra- dial prosthesis to the long process of the incus. It is unknown which forces
phy, micro grinding technique, and scanning electron microscopy. An algo- occur during the crimping process that increase the risk of damage to the

14
incudomalleolar joint or incus luxation. The goal of this study was to assess Published: Laryngoscope, 2009 Dec; 119(12): 2421-7
the admissible range of forces at the long process of the incus that would DOI: 10.1002/lary.20641
be tolerable before damaging the structures and to compare them with the
forces occurring during surgery. Objectives/Hypothesis: The aim of the study was to gain the first clini-
cal experience with a new titanium clip prosthesis in stapes surgery, and to
Methods: Load-deflection curves in the lateral-medial and anterior-poste- compare this model with its predecessor. We placed particular emphasis on
rior direction were measured in 9 freshly frozen or fresh temporal bones. the practicability of fixing the prosthesis to the long process of the incus and
The force was measured with a load cell, and displacement was taken from on the postoperative improvement in hearing. Study Design: Retrospective
the encoder information of the electrically driven translation stage on which chart review.
the load cell was mounted. The long process of the incus was coupled to the
load cell via a customized needle. We also monitored with video recordings Methods: The study included 23 patients who had a CliP Piston à Wengen
for visual confirmation of findings. fitted and 21 patients with a Soft CliP Piston (both from Kurz Medizintech-
nik, Dusslingen, Germany). Air and bone conduction were tested preoper-
Results: The rupture force at which the middle ear was found to be severe- atively and 5 to 6 weeks after surgery in all patients, as well as after about
ly injured was 894 (724-1018) mN in the anterior-posterior direction and 1 year in a subgroup.
695 (574-771) mN in the lateral-medial direction. Micro-ruptures occurred
at forces around 568 (469-686) mN in the anterior-posterior direction and Results: We found a mean air-bone gap of 8.5 +/- 5.2 dB in the frequen-
in the lateral-medial direction at 406 (254-514) mN. Short-term maximum cies 0.5, 1, 2, and 3 kHz for the patients with a CliP Piston à Wengen at
forces of 1,321 (1,051-1,533) mN were measured in the anterior-posterior follow-up audiometry after an average of 31 days, and of 6.4 +/- 3.7 dB for
direction and 939 (726-1,132) mN in the lateral-medial direction. 11 patients after 412 days. The corresponding figures for patients with Soft
CliP Pistons were 8.9 +/- 4.1 dB after 44 days, and 6.3 +/- 5.6 dB for 10
Conclusion: Rupture forces of the incudomalleolar joint could be defined patients after 419 days. There were no statistically significant differences.
with high accuracy. These results were used to calculate risks of incus lux- All the prostheses were implanted without difficulty.
ation or subluxation during stapes surgery. Compared with the use of clip
and SMA prostheses, the risk of damage from a crimping procedure is sig- Conclusions: The two stapes prostheses studied gave good early audiometric
nificantly higher. results that showed no difference. After a short learning period, both could be
pushed onto the long process of the incus with similar ease, although subjec-
tively the new design of the Soft CliP seemed to adapt better to the different
Diagnostic Findings in Stapes Revision Surgery - diameters of the process and took up less space in the middle ear.
A Retrospective of 26 Years

Schimanski G., Schimanski E., Berthold M. R. Stapes surgery: First experiences with the
new Soft-CliP® Piston
Published: Otology & Neurotology: April 2011 - Volume 32(3): 373-383
DOI: 10.1097/MAO.0b013e3182096da1 Brase C., Zenk J., Wurm J., Schick B., Iro H., Hornung J.

Objectives: The aim of the study is to obtain a detailed overview of the Published: HNO 2009:57(509-513). (German)
revision findings after stapes operations and to draw conclusions on a stapes DOI: 10.1007/s00106-009-1899-y
prosthesis that can be recommended.
Background: The first hearing results with a new stapes prosthesis with
Study Design: Retrospective case series. Setting: Tertiary otologic referral clip function (Soft-CliP® piston) are presented.
center.
Patients and Methods: This new prosthesis was used in 15 patients (mean
Methods: Approximately 12,000 middle ear operations within a period of age 45.2 years; range 21-63 years) undergoing routine stapes surgery. Soft-
26 years were evaluated. The findings of the revisions were classified into CliP® piston prostheses with a shaft diameter of 0.4 mm and a length rang-
surgeon related, prosthesis related, and other causes. ing from 4.25 mm to 5.5 mm were used. Postoperative audiological testing
and measurement of the air-bone gap were performed after an average of
Results: Three hundred forty-three stapes revisions were done. Many differ- 47.3 days and compared with the preoperative values.
ent prostheses were found: the most common were Schuknecht prostheses
and Teflon platinum, gold, and titanium pistons. Polyethylene strut, Teflon Results: The median observed postoperative air-bone gap (ABG) was
wire pistons, Shea (Teflon) pistons, and other techniques, such as columel- 8.33 dB ±4.16 dB. All patients had less than 20 dB ABG and in 53.3% of
la or malleovestibulopexy, were rarely found. There are specific findings cases was less than 10 dB. The operating time showed a clear difference
correlating to certain prostheses: Schuknecht prostheses were too short in between the left (66.5 min ±37.79 min) and right ears (47.2 min ±11.08 min).
50% of the revisions (surgeon related), Teflon platinum caused necrosis or
arrosion of the long incudal process (prostheses related) in 69%, and gold Discussion: This new prosthesis design greatly facilitates a very difficult
caused reparative granuloma sometimes combined with necosis of the incus step in stapes surgery, the prosthesis fixation to the incus. The first postop-
in 70% (prostheses related). There was no specific diagnostic finding with erative hearing results are very promising but long-term results in a larger
titanium pistons, neither surgeon nor material related. group of patients are still pending.

Conclusion: An analysis of revision findings over an extended observation

period can enable middle-ear surgeons to improve their surgical techniques Development of a new CliP-Piston prosthesis for the Stapes
and to select the best suited prosthesis. Self-fabricated stapes prostheses
(e.g., Schuknecht) do not conform to required quality standards and should Schimanski G., Steinhardt U., Eiber A.
not be used. GoPi, which is no longer available, and TPlPi showed prosthe-
sis-related diagnostic findings. The titanium prostheses used by the authors Published: Proceedings of the 4th International Symposium. Zurich, Swit-
have proven to be excellently compatible and can therefore be recommend- zerland, 27 - 30 July 2006. Middle Ear Mechanics in Research and Otology:
ed as safe stapes prostheses. pp. 237-245. DOI: 10.1142/9789812708694_0032

275 inserted Clip-Pistons type “ à Wengen” within three years revealed dif-
First Experience With a New Titanium Clip Stapes Prosthesis ficulties in 14.5% of the cases. In those cases it was necessary to make ad-
and a Comparison With the Earlier Model Used in Stapes justments to the clip shape (plastic deformation) before insertion due to the
Surgery individual dimension of the long incudal process. During 100 middle ear
surgeries the cross sections of the long incudal processes where the clip is
Hornung J. A., Brase C., Bozzato A., Zenk J., Iro H. attached was measured. This resulted in data hitherto unknown. By virtue

15
of a Finite Element Model (FEM) these data were used for optimizing the fitted and 21 patients with a Soft CliP Piston (both from Kurz Medizintech-
clip shape. Design criteria were a minimal variation of the contact force nik, Dusslingen, Germany). Air and bone conduction were tested preoper-
for different cross-sections and to minimize the force necessary to slide the atively and 5 to 6 weeks after surgery in all patients, as well as after about
clip over the incudal process. The new clip has a lower stiffness and can 1 year in a subgroup.
therefore be applied onto different incus diameters. The lower contact force
reduces the risk of arrosion. Due to its optimized shape, the maximal stress Results: We found a mean air-bone gap of 8.5 +/- 5.2 dB in the frequen-
in the clip is lowered preventing plastic deformation during the application cies 0.5, 1, 2, and 3 kHz for the patients with a CliP Piston à Wengen at
procedure. The application force was decreased by up to 45% depending follow-up audiometry after an average of 31 days, and of 6.4 +/- 3.7 dB for
on the application points. This leads to easy and safe application reducing 11 patients after 412 days. The corresponding figures for patients with Soft
the risk of damaging the ossicular chain. CliP Pistons were 8.9 +/- 4.1 dB after 44 days, and 6.3 +/- 5.6 dB for 10
patients after 419 days. There were no statistically significant differences.
All the prostheses were implanted without difficulty.

CLIP PISTON À WENGEN Conclusions: The two stapes prostheses studied gave good early audio-
metric results that showed no difference. After a short learning period,
both could be pushed onto the long process of the incus with similar ease,
Diagnostic Findings in Stapes Revision Surgery - although subjectively the new design of the Soft CliP seemed to adapt bet-
A Retrospective of 26 Years ter to the different diameters of the process and took up less space in the
middle ear.
Schimanski G., Schimanski E., Berthold M.R.

Published: Otology & Neurotology: April 2011 - Volume 32(3): 373-383 CO2 laser-assisted stapedotomy
DOI: 10.1097/MAO.0b013e3182096da1 combined with à Wengen titanium clip stapes prosthesis:
superior short-term results
Objectives: The aim of the study is to obtain a detailed overview of the
revision findings after stapes operations and to draw conclusions on a stapes Forton G. E. J., Wuyts J., Floris L., Delsupehe K. G.,
prosthesis that can be recommended. Verfaillie J., Loncke R.

Study Design: Retrospective case series. Setting: Tertiary otologic referral Published: Otology & Neurotology: December 2009; 30(8):1071-8
center. DOI: 10.1097/MAO.0b013e3181a52ab4

Methods: Approximately 12,000 middle ear operations within a period of Objectives: To report on the short-term results of CO2-laser assisted stape-
26 years were evaluated. The findings of the revisions were classified into dotomy combined with the à Wengen titanium clip stapes prosthesis. A
surgeon related, prosthesis related, and other causes. comparison with published series using other prostheses and/or different
stapedotomy techniques is made.
Results: Three hundred forty-three stapes revisions were done. Many differ-
ent prostheses were found: the most common were Schuknecht prostheses Study Design: Retrospective case series.
and Teflon platinum, gold, and titanium pistons. Polyethylene strut, Teflon
wire pistons, Shea (Teflon) pistons, and other techniques, such as columel- Patients: Patients with a history and audiologic data matching stapes fix-
la or malleovestibulopexy, were rarely found. There are specific findings ation and computed tomographic imaging excluding other anomalies such
correlating to certain prostheses: Schuknecht prostheses were too short in as malleus fixation, dehiscent superior semicircular canal, and large vestib-
50% of the revisions (surgeon related), Teflon platinum caused necrosis or ular aqueduct that may mimic stapes fixation-like hearing loss.
arrosion of the long incudal process (prostheses related) in 69%, and gold
caused reparative granuloma sometimes combined with necosis of the incus Intervention: All patients underwent CO2 laser-assisted stapedotomy
in 70% (prostheses related). There was no specific diagnostic finding with (Lumenis Co. Israel CO2 laser, Acuspot 712, SurgiTouch 870 scanner) and
titanium pistons, neither surgeon nor material related. subsequent reconstruction by means of the àWengen titanium clip stapes
prosthesis by Heinz Kurz Medizintechnik GmbH (Germany).
Conclusion: An analysis of revision findings over an extended observation
period can enable middle-ear surgeons to improve their surgical techniques Outcome Measures: Comparison and statistical analysis of preoperative
and to select the best suited prosthesis. Self-fabricated stapes prostheses and postoperative audiologic data.
(e.g., Schuknecht) do not conform to required quality standards and should
not be used. GoPi, which is no longer available, and TPlPi showed prosthe- Results: Sixty-two stapedotomies were performed (61 patients) using the
sis-related diagnostic findings. The titanium prostheses used by the authors CO2 laser and àWengen titanium clip stapes prosthesis. The mean postop-
have proven to be excellently compatible and can therefore be recommend- erative air-bone gap 3 months postoperatively was 5.1 ± 0.5 dB (standard
ed as safe stapes prostheses. deviation [SD], 4.1 dB; 0.5, 1, 2, 4 kHz). Air-bone gap closure less than or
equal to 10 dB was achieved in 54 cases (87%). Air-bone gap closure less
than 20 dB was achieved in all cases. The average gain was 27.8 ± 1.5 dB
First Experience With a New Titanium (SD, 12 dB; 0.5, 1, 2, 4 kHz). The average bone-conduction threshold shift
Clip Stapes Prosthesis and a Comparison With the Earlier or “overclosure” on 2,000 Hz was 13.6 ± 1.3 dB (SD, 10 dB). There was
Model Used in Stapes Surgery no postoperative perceptive hearing loss exceeding 15 dB on any measured
frequency. The Amsterdam Hearing Evaluation Plots have also been used
Hornung J. A., Brase C., Bozzato A., Zenk J., Iro H. to evaluate our data. These data were statistically analyzed and compare
favorably to other published series.
Published: Laryngoscope, 2009 Dec;119(12):2421-7
DOI: 10.1002/lary.20641 Conclusion: The authors conclude that the combination of CO2 laser-as-
sisted stapedotomy and the àWengen titanium clip stapes prosthesis is a
Objectives/Hypothesis: The aim of the study was to gain the first clini- combination likely to yield superior results in experienced hands.
cal experience with a new titanium clip prosthesis in stapes surgery, and to
compare this model with its predecessor. We placed particular emphasis on
the practicability of fixing the prosthesis to the long process of the incus Development of a new CliP-Piston prosthesis for the Stapes.
and on the postoperative improvement in hearing. Study Design: Retro- Middle Ear Mechanics in Research and Otology
spective chart review.
Schimanski G., Steinhardt U., Eiber A.
Methods: The study included 23 patients who had a CliP Piston à Wengen

16
Published: Proceedings of the 4th International Symposium. Zurich, No more crimping: the new clip piston à Wengen.
Switzerland, 27 - 30 July 2006. Middle Ear Mechanics in Research and Visiting Professor at HNO-University Hospital Basel, Switzerland
Otology: pp. 237-245. à Wengen D.
DOI: 10.1142/9789812708694_0032
Published: 24th Politzer Meeting 31 August – 4 September 2003, Amster-
275 inserted Clip-Pistons type “ à Wengen” within three years revealed dif- dam, the Netherlands: Selected Abstracts
ficulties in 14.5% of the cases. In those cases it was necessary to make
adjustments to the clip shape (plastic deformation) before insertion due to Objective: Crimping of the stapes prosthesis might result in injury to the in-
the individual dimension of the long incudal process. During 100 middle ear cus. Attachment is often not tight. Facilitated fixation of a stapes prosthesis
surgeries the cross sections of the long incudal processes where the clip is could improve surgery and provide more stable results.
attached was measured. This resulted in data hitherto unknown. By virtue
of a Finite Element Model (FEM) these data were used for optimizing the Method: After development of a unique titanium clip over a seven year
clip shape. Design criteria were a minimal variation of the contact force period (Kurz AG, Dusslingen Germany) and reception of a CE-mark, the
for different cross-sections and to minimize the force necessary to slide the first implantation was performed in September 2000. Full FDA approval
clip over the incudal process. The new clip has a lower stiffness and can was received in June 2002. Up to May 2003 more than 2400 Clip Piston
therefore be applied onto different incus diameters. The lower contact force àWengen have been purchased in several countries around the world.
reduces the risk of arrosion. Due to its optimized shape, the maximal stress
in the clip is lowered preventing plastic deformation during the application Results: Only 60% of the circumference of the incus is touched by the clip
procedure. The application force was decreased by up to 45% depending on permitting adequate mucosal blood supply to the lenticular process. Appli-
the application points. This leads to easy and safe application reducing the cation of the prosthesis is quick and stable. There is no need for crimping
risk of damaging the ossicular chain. anymore. The clip holds precisely in the main axis of movement of the long
process of the incus.

First Experience with a New Stapes Clip Piston in Stapedotomy Conclusion: This new stapes prosthesis facilitates surgery and reduces OR-
time. There is no need for crimping anymore. Acoustic coupling is ideal due
Grolman W., Tange R. A. to the spring action of the self-retaining clip. Most surgeons have switched
entirely to this prosthesis. Long-term results will be needed to prove the
Published: Otology & Neurotology: 2005 July;26(4):595-8 reduction of incus necrosis. In the nearly three year period of observation
DOI: 10.1097/01.mao.0000178132.89353.54 since the first implantation there was no loosening of the clip.

Objecvtive: Hearing results after 23 implantations of a newly designed tita-

nium-clip stapes piston prosthesis (the à Wengen Clip Piston prosthesis) in
patients with otosclerosis were evaluated. This is a new type of stapes piston CLIP PISTON MVP
was designed to avoid the crimping onto the incus in stapedotomy. This one
clip fits all designs and enables solid fixation by clicking the prosthesis onto
the long process of the incus without crimping. A New Self-Fixing and Articulated Malleus Grip
Stapedectomy Prosthesis
Study Design: A retrospective pilot study was carried out by microcomput-
er of the preoperative and postoperative audiological results of patients in Häusler R., Steinhardt U.
whom the titanium-clip stapes piston prosthesis was implanted.
Published: Adv Otorhinolaryngol, (2007) Vol 65, 197-201
Setting: Ear, nose and throat department of Academic Medical Center, Uni- DOI: 10.1159/000098807
versity of Amsterdam, Amsterdam, The Netherlands.
A new prosthesis for malleus-grip stapedectomy is presented: the Clip®
Patients: 23 patients underwent a stapedotomy for hearing improvement Piston MVP according to Häusler. The titanium piston is equipped with a
suffering from otosclerosis. Implantations of a newly designed titanium-clip self-fixing clip mechanism for automatic fixation of the prosthesis on the
stapes piston prosthesis (the à Wengen Clip Piston prosthesis) in patients proximal malleus handle as well as a ball and socket articulation allowing
with otosclerosis were evaluated. easy introduction of the piston at an optimal angle into the oval window
as well as adjustment of the insertion depth. A first series of malleus-grip
Intervention(s): The stapedotomy was performed with the à Wengen Clip stapedectomies performed with the Clip® Piston MVP shows a hearing
Piston prosthesis. gain of 20 to 50 dB and a residual air-bone gap of ≥ 20 dB in all cases.
In one patient, revision surgery was necessary because of piston ejection
Main outcome measure(s): Pre and postoperative audiograms were used from the oval window. It appears that with the new Clip® Piston MVP
to evaluate the hearing gain improvement with the new stapes piston. Es- the previously difficult surgery of malleus-grip stapedectomy has become
pecially we looked at the airbone gap closure and the sensorineural hear- straight forward and technically simpler.
ing after the surgical procedure and compared these with the ones before
surgery.
Initial Experience with Titanium MVP Clip Prosthesis
Results: The hearing results showed a closure of the pure-tone average
air-bone gap to within 10 dB in 56.6% of cases (10 of 23 implantations) Singh P. P.
and to within 20 dB in 100% (23 of 23 implantations). A residual air-bone
gap of greater than 20 dB was seen in the present pilot study. Postoper- Published: MEMRO 2006, 4th International Symposium on Middle Ear
ative overclosure of bone-conduction thresholds was discovered only for Mechanics in Research and Otology: Selected Abstracts
the frequency of 2 kHz. Sensorineural hearing loss greater than 10% did
not occur, and there was no decline in the speech discrimination. Introduction: After introduction of stapes surgery malleovestibulopexy
(MVP) was the natural extention of this procedure. Although the hear-
Conclusions: The use of a newly designed titanium-clip stapes piston ing results of stapes surgery were usually excellent, the hearing results of
prosthesis with a diameter of 0.4 mm gives good results in cases of stape- MVP were quite variable. This probably resulted from poor understanding
dotomy for otosclerosis. The titanium-clip design is a new development of middle ear mechanics and usage of the same prosthesis as used for sta-
in the evolution of stapes piston prostheses. Surgical introduction, place- pes surgery. Modification of prosthesis design and technique has resulted
ment, and fixation are not always easy, depending on the anatomy of the in improved hearing outcomes after this procedure.
middle ear and the thickness of the fixation area on the long process of
the incus. Purpose: To evaluate the hearing outcomes of malleovestibulopexy using
titanium MVP clip prosthesis which has recently been introduced.

17
Material and Methods: Six patients undergoing exploratory tympanoto- Objectives/Hypothetis: To review hearing results and complications for
my for congenital conductve hearing loss or failed stapes surgery and requir- the NiTiBOND next generation shape memory prosthesis and compare
ing malleovestibulopexy are included in this study. Extended tympanomeatal them with results for the current shape memory prosthesis (SMart). Study
flap was employed for exposure of middle ear and upper malleus handle. The Design: Retrospective, multicenter chart review.
prosthesis was introduced and the clip was slipped on malleus handle. Minor
adjustments were required to attain the perpendicularity of the shaft and shaft Methods: Primary laser stapedotomy was performed using either a
insertion in the vestibule. Drilling of handle with diamond burr was required NiTiBOND or a SMart prosthesis. Ninety-two ears in 79 patients were
in half the cases to better adapt the clip on malleus handle. included in the study (67.4% female), 52 with the NiTiBOND prosthesis
and 40 with the SMart prosthesis. Data collected included demograph-
Results: The mean of air-bone gap averaged over speech frequencies was ic variables, pre- and postoperative pure-tone air and bone conduction
within 20 dB in all six cases and within 10 dB in four cases. No deteriora- thresholds, speech discrimination scores, complications, and the need for
tion of bone conduction threshold was observed. revision surgery. Pure-tone average (PTA) and PTA air-bone gap (ABG)
pre- and postoperative were computed. Success was defined as a postop-
Conclusions: The hearing resuts of malleovestibulopexy using newly in- erative ABG of ≤10 dB.
troduced titanium MVP clip prosthesis have been encouraging and almost
equal results of stapes surgery. The improved results seem to be consequent Results: There were no significant differences between groups in hear-
to the unique design of the prosthesis which factors in two key variables of ing results, including improvement in ABG, change in speech discrimina-
this procedure viz anchorage of prosthesis on malleus handle and perpen- tion, change in air or bone PTA, or change in high-frequency bone PTA.
dicularity of the prosthesis shaft in relation to stapes footplate. Short-term (mean = 4.4 and 4.9 weeks, respectively) success rates for the
NiTiBOND and SMart prostheses were 84.6% and 70.0%, respectively,
with this difference closing at the most recent test (83.7% and 80.0%,
Laser doppler vibrometry data of the Clip piston MVP respectively). No revision surgery took place in either group, and there
were no differences in complications such as dizziness, tinnitus, or taste
Arnold A., Stieger CH., Häusler R. disturbance, though the NiTiBOND group tended to have a lower rate of
transient or permanent vertigo.
Published: MEMRO 2006, 4th International Symposium on Middle Ear
Mechanics in Research and Otology: Selected Abstracts Conclusions: Compared with the SMart prosthesis, the NiTiBOND pros-
thesis is a safe prosthesis that achieves at least comparable hearing results
Background: A new malleus handle prosthesis for malleo-vestibulopexy and may offer some surgical advantages.
and revision stapedotomy has been developed at our departement and
successfully used during the last five years. The piston prosthesis bears
the CliP®-mechanism to facilitate attachment to the malleus handle and How to Avoid a Learning Curve in Stapedotomy:
length and position can easily be adjusted intraoperatively with a movable A Standardized Surgical Technique
hinge.
Kwok P., Gleich O., Dalles K, Mayr E., Jacob P., Strutz J.
Objective: The study was devised to determine if the special developed
hinge of the CliP Piston MVP causes a loss of sound transfer from the mal- Published: Otology & Neurotology 2017 Aug;38(7):931-937.
leus grip to the vestibulum. DOI: 10.1097/MAO.0000000000001475

Methods: A middle ear model was set up, consisting of a vibrator normally Objective: To evaluate, whether a learning curve for beginners in stapedoto-
used in an active implantable hearing device with a metal arm in shape and my can be avoided by using a prosthesis with thermal memory-shape attach-
dimension of an actual malleus handle, where the CliP Piston MVP was at- ment in combination with a standardized laser-assisted surgical technique.
tached with the hinge bend to an angle of about 120°. The piston end of the
prosthesis dipped in a hole of a plastic container filled with water simulating Study Design: Retrospective case review. Setting: Tertiary referral center.
a piston hole in the footplate. The excitation level corresponded to more than Patients: Fifty-eight ears were operated by three experienced surgeons and
110 dB SPL for frequencies between 100 Hz – 10000 Hz. With a laser dop- compared with a group of 12 cases operated by a beginner in stapedotomy.
pler vibrometer the movements were picked up at different spots in the area Intervention: Stapedotomy. Main Outcome Measures: Difference of pure-
of the clip, the hinge and the piston. tone audiometry thresholds measured before and after surgery.

Results: The overall characteristics of the transferfunction was practi- Results: The average postoperative gain for air conduction in the frequen-
cally identical (difference < 3dB). Additionally biphasic resonance peaks cies below 2 kHz was 20 to 25 dB and decreased for the higher frequen-
(5-10 dB) were observed around 1000 Hz. cies. Using the Mann-Whitney-U test for comparing mean gain between
experienced and inexperienced surgeons showed no significant difference
Discussion: Our results show very stable transfer properties over the fre- (p = 0.281 at 4 kHz and p > 0.7 for the other frequencies). A Spearman rank
quency band. The noticed resonance peaks of 5-10 dB are very probably correlation of the postoperative gain for air- and bone-conduction thresh-
below significance level in clinical pure tone audiometry. This is in accor- olds was obtained at each test frequency for the first 12 patients consecu-
dance with our experience from clinical practice. tively treated with a thermal memory-shape attachment prosthesis by two
experienced and one inexperienced surgeon. This analysis does not support
Conclusion: The CliP Piston MVP provides good transfer characteristics the hypothesis of a "learning effect" that should be associated with an im-
from the malleus handle to the vestibulum. proved outcome for successively treated patients.

Conclusion: It is possible to avoid a learning curve in stapes surgery by ap-

plying a thermal memory-shape prosthesis in a standardized laser-assisted
NITIBOND surgical procedure.

Next generation shape memory prosthesis (NiTiBOND) Early functional results using the NiTiBOND® prosthesis
for stapedotomy: Short-term results in stapes surgery

Green J.D. Jr, McElveen J.T. Jr. Canu G., Lauretani F., Russo F. Y., Ferrary E., Lamas G.,
Sterkers O., De Seta D., Bernardeschi D.
Published: Laryngoscope. 2017 Apr;127(4):915-920.
DOI: 10.1002/lary.26114 Published: Acta Otolaryngol. 2016 Nov 4:1-6
DOI 10.1080/00016489.2016.1247499

18
Conclusion: The NiTiBOND® prosthesis allows early results to be obtained Objective: Analysis of 12-month midterm clinical and audiometric data
similar to those with a manually crimped prosthesis fitted by experienced sur- of patients with otosclerosis who underwent stapedotomy using a newly
geons, thus reducing the learning curve in this critical step of the procedure. designed prosthesis made of nitinol, a shape memory alloy.

Objective: To analyze the 1-month results using the nitinol NiTiBOND® Patients: Fifty-five ears of 50 consecutive patients who underwent stape-
prosthesis in primary otosclerosis surgery and to compare the results with totomy between March 2010 and July 2011 were included. They met the
those obtained with fully fluoroplastic or fully titanium pistons. inclusion criteria of primary procedures, a clinical follow-up and absence
of nickel allergy.
Materials and Methods: Fifty consecutive cases operated on with the
NiTiBOND® prosthesis (nitinol group) were compared with 50 cases oper- Intervention: Stapedotomy and insertion of a newly designed stapes prosthesis.
ated on with a fully fluoroplastic piston (fluoroplastic group), and with 131
cases operated on with a fully titanium piston (first titanium group), and Main Outcome Measures: Preoperative and postoperative (3 and 12 mo)
also with 50 cases operated on with the same titanium piston just before air and bone conduction thresholds were recorded. Pure tone average and air
using the NiTiBOND® piston (last titanium group). Pure-tone and speech bone gap (difference of air and bone conduction thresholds) were calculated
audiometry was performed 1 month after surgery for the nitinol group. for 500, 1,000, 2,000, and 3,000 Hz. The occurrence of complications was
Comparison was made between the early hearing results of the four groups. assessed.

Results: The mean air-bone gap closure for the nitinol group was 16 ± 1.0 dB Results: Air conduction thresholds, pure tone average, and airbone gap
(mean ± SEM, n = 50); an air-bone gap of <15 dB and <10 dB was obtained improved significantly 3 and 12 months postoperatively. Bone conduction
in 100% and 84% of cases, respectively. These hearing results were similar threshold improved significantly at 2,000 Hz 3 months postoperatively and
to the last titanium group and significantly better than those observed in the at 1,000 and 2,000 Hz 12 months postoperatively. A PTA of less than 20 dB
fluoroplastic and first titanium groups. was achieved in 96% of ears. No sensorineural hearing loss or other pros-
thesis-related adverse effects were observed.

Promising Clinical Results of an Innovative Self-Crimping Conclusion: Postoperative hearing results are comparable to the results
Stapes Prosthesis in Otosclerosis Surgery obtained with other self-crimping prostheses. No complications or failures
related to the prosthesis occurred. A longer followup is necessary to prove
Schrötzlmair F., Suchan F., Kisser U., Hempel J.-M., Sroka R., long-term stability of hearing results and safety of the new prosthesis.
Müller J.

Published: Otology & Neurotology: December 2013 - Volume 34 - Issue Clinical Evaluation of the NiTiBOND Stapes Prosthesis,
9 - p 1571–1575. DOI: 10.1097/MAO.0b013e3182a5d12d an Optimized Shape Memory Alloy Design

Objectives: This clinical study was performed to retrospectively analyze Huber A. M., Schrepfer T., Eiber A.
the hearing improvement of patients with otosclerosis who underwent sta-
pesplasty with a novel nitinol prosthesis in comparison with the use of al- Published: Otology & Neurotology: February 2012 - Volume 33
ready established prostheses (titanium and clip prostheses) and to evaluate DOI: 10.1097/MAO.0b013e31823e28cb
the suitability of the nitinol prosthesis for ear surgeons with limited experi-
ence in otosclerosis surgery. Objective: To prospectively analyze short-term (3 mo) results in patients
with otosclerosis who underwent stapedotomy with the newly designed
Study Design: Retrospective data analysis. Setting: Tertiary referral center. NiTiBOND prosthesis and compare them with patients that underwent SMart
piston stapedotomy. We aimed to assess “noninferiority” for the new prosthesis.
Patients: Sixty patients who underwent otosclerosis surgery between July
1, 2010, and June 30, 2012, in the ENT department of the University of Study Design: Prospective controlled trial. Setting: Tertiary referral center.
Munich. Two patients were operated on both sides. For four patients, the Patients: Thirty-eight patients were included in the NiTiBOND group (41
stapesplasty was a revision surgery. ears), and 74 patients were included in the SMart Piston group (75 ears).
Intervention(s): Stapedotomy.
Interventions: Sixty-two procedures of otosclerosis surgery were per-
formed by 6 ear surgeons, one of whom with profound experience in sta- Main Outcome Measure(s): Pure-tone audiometry 3 months after surgery,
pesplasty. intraoperative prosthesis handling as assessed using a questionnaire, and
complications were analyzed.
Main Outcome Measures: 1) Postoperative air-bone gap, determined for
all surgeons together as well as itemized for the experienced and the nonex- Results: Pure-tone audiometry showed postoperative air-bone gap means
perienced stapes surgeons; 2) closure of the air-bone gap in 10 dB bins; and (standard deviation) of 8.1 (8.3) and 9.9 (5.4) dB; air-bone gap closure
3) change of high-tone bone-conduction level. within 10 dB was achieved in 71% and 72% and within 20 dB in 93%
and 96% for the NiTiBOND and the SMart piston prosthesis, respectively.
Results: Pure-tone audiometry documented less postoperative air-bone gap Noninferiority was shown at all frequencies and in the pure-tone average.
and a higher percentage of air-bone gap closure when using the nitinol pros- The NiTiBOND prosthesis provides excellent intraoperative handling, and
thesis, especially in comparison with the clip prosthesis. Also, nonexperi- no adverse reactions were reported.
enced stapes surgeons received better audiometric results when using the
novel nitinol prosthesis. Conclusion: Preliminary short-term results suggest safety and reliability
for the new NiTiBOND stapes prosthesis.
Conclusions: Clinical evaluation suggests the novel nitinol prosthesis to be
a promising tool in otosclerosis surgery for experienced stapes surgeons as
well as for ear surgeons with limited experience in stapes surgery.
S TA P E S P R O S T H E S E S

Mid-Term Results After a Newly Designed Nitinol

Stapes Prosthesis Use in 46 Patients Does the diameter of the stapes prosthesis really matter?
A prospective clinical study
Röösli C., Huber A. M.
Bernardeschi D., De Seta D., Canu G., Russo F.Y.,
Published: Otology & Neurotology 2013 Sep; 34(7) Ferrary E., Lahlou G., Sterkers O.
DOI: 10.1097/MAO.0b013e318299a973

19
Published: Laryngoscope. 2018 Aug;128(8):1922-1926. Type III tympanoplasty applying the palisade cartilage
DOI: 10.1002/lary.27021. Epub 2017 Nov 24. technique: a study of 61 cases

Objectives/Hypothetis: To evaluate the influence of the diameter of stapes Neumann A., Schultz-Coulon H.-J., Jahnke K.
prosthesis on functional outcomes in stapes surgery. Study Design: Pro-
spective cohort study. Published: Otol Neurotol. 2003 Jan;24(1):33-7.

Methods: Fifty consecutive small fenestra stapedotomies performed using Objective: To determine the morphologic and hearing results of the com-
a 0.4-mm-diameter prosthesis were compared with 50 consecutive small bined application of the palisade cartilage technique and titanium ossicular
fenestra stapedotomies carried out using a 0.6-mm-diameter piston. Audi- replacement prostheses in Type III tympanoplasty.
ological assessment following the recommendations of the Committee on
Hearing and Equilibrium was performed 1 month after surgery. Postopera- Study Design: Retrospective review of 61 tympanoplasties. Setting: Tertiary
tive complications between the two groups were noted. referral center. Patients: 59 patients (39 women and 20 men, mean age 36
years, range 7-81 years) consecutively operated on because of cholesteatoma,
Results: There were no statistically significant differences in demographic adhesive otitis, chronic otitis media, subtotal tympanic membrane defects,
data between the two groups, and no differences in preoperative bone-con- and tympanofibrosis requiring tympanoplasty with ossiculoplasty.
duction (BC) or air-conduction (AC) hearing thresholds for all frequencies
(analysis of variance [ANOVA] and χ2 tests). No differences were found Interventions: Tympanoplasty Type III, with application of the palisade car-
in the mean preoperative BC and AC pure-tone average and air-bone gap tilage technique and total or partial titanium ossicular replacement prosthesis.
(ABG). In the postoperative evaluation, a statistically significant difference
was found for the mean AC gain (20 ± 8.7 vs. 24 ± 11.5, P = .042, ANOVA) Main Outcome Measures: Otoscopic findings and hearing results using a
as well as for the postoperative AC threshold at 0.125 and 0.25 kHz and the four-frequency pure tone average air-bone gap.
postoperative BC threshold at 0.25 kHz (P < .01, ANOVA). A postoperative
ABG ≤10 dB was obtained in 90% and 94% of patients in the 0.4-mm- and Results: A recurrent defect was seen in 1 ear (1.6%). The graft take rate was
0.6-mm-diameter piston groups, respectively (difference not significant, 100%. There were no extrusions of prostheses. Preoperatively, a pure tone
χ2 test). No postoperative dead ear and/or sensorineural hearing loss was average air-bone gap of 0 to 10 dB was seen in 1 ear, 11 to 30 dB in 30, and
noted in either group. 31 to 50 dB in another 30 ears. Postoperatively, the corresponding numbers
were 11, 41, and 9 ears, respectively. Hearing results were better in the total
Conclusions: The 0.6-mm piston allowed a statistically significant higher ossicular replacement prosthesis group.
AC gain compared with the 0.4-mm diameter piston. A larger diameter
piston may be preferable if there are no anatomical or technical reasons Conclusion: The palisade cartilage technique is suitable to manage difficult
that would favor a smaller prosthesis. pathologic conditions in middle ear surgery. It was demonstrated that the
palisade cartilage technique can be combined safely with titanium ossicular
replacement prostheses. Regarding postoperative hearing results, the nega-
tive preselection of pathologic conditions must be considered.
KURZ PRECISE CARTILAGE KNIFE

Acoustic properties of different cartilage reconstruction

Cartilage Plate Tympanoplasty techniques of the tympanic membrane

Beutner D., Huettenbrink K.-B., Stumpf R., Beleites T., Mürbe D., Zahnert T., Bornitz M., Hüttenbrink K.-B.
Zahnert T., Luers J.-C., Helmstaedter V.
Published: Laryngoscope 2002 Oct; 112(10):1769-76.
Published: Otology & Neurotology, 2009 DOI: 10.1097/00005537-200210000-00012
DOI: 10.1097/MAO.0b013e3181be6b48
Objectives/Hypothesis: The use of cartilage in reconstruction of the tym-
Objectives: The purpose of this work was to report our modified cartilage panic membrane has been established especially in cases such as tubal dys-
plate tympanoplasty technique ("tulip leaves") and to analyze its clinical function and adhesive processes. Cartilage offers the advantage of higher
outcome in primary and recurrent cases of chronic otitis media with and mechanical stability compared with membranous transplants but may alter
without cholesteatoma. the acoustic transfer characteristics of the graft. Apart from material proper-
ties, it can be assumed that, also, the microsurgical reconstruction technique
Study Design: Clinical retrospective study. might influence the sound transmission properties of the reconstructed tym-
panic membrane. The purpose of the study was to investigate the acoustic
Methods: Patients being operated on with this technique at the University transfer characteristics of different cartilage transplants being typically used
Department of Otorhinolaryngology, Dresden, Germany, between 1993 and in different reconstruction techniques of the tympanic membrane.
2001 were invited for survey, otomicroscopy, and pure-tone audiometry in
2003. Patients’ charts were used to draw necessary conclusions. Methods: Cartilage plates of different thicknesses (1.0, 0.7, 0.5, and
0.3 mm), cartilage palisades, and cartilage island transplants of varying size
Results: A total of 39 patients who were treated with this technique af- were investigated by means of an ear canal-tympanic membrane model. In
ter canal wall down tympanomastoidectomy and cavity obliteration were contrast to former single-point measurements, sound-induced vibrational
included in this long-term analysis after a median follow-up of 6 years. amplitudes of the entire transplant were measured by scanning laser Dop-
Seventeen patients (44%) experienced chronic otitis media with choleste- pler vibrometry (measuring points, n = 133) (PSV-200, Polytec, Waldbronn,
atoma, whereas 22 (56%) of them had a diagnosis of chronic otitis media Germany). Frequency response functions (displacement vs. sound pressure)
without cholesteatoma. At the time of examination, all patients displayed of all measured points were determined in the frequency range of 200 Hz to
a closed tympanic membrane. However, retractions were observed in 19 4 kHz for the different transplants.
patients (48%). One patient required (3%) revision surgery for recurrent
cholesteatoma due to prosthesis extrusion during the study period. Results: Cutting thick cartilage transplants into thin plates or palisades de-
creased the first resonance frequency and increased its amplitude, reflecting
Conclusion: On the basis of this study, we recommend the tuliplike ar- improved sound transmission properties of the transplant. From an acous-
rangement of thin but large auricular cartilage slices for the reconstruction tical point of view, the 0.5-mm cartilage plate seems preferable compared
of tympanic membrane defects in high-risk ears. This combination proved with the palisade technique. Cartilage island techniques showed vibration
its high stability and long-lasting vitality in our long-term study. These char- characteristics superior to plate or palisade techniques.
acteristics are crucial for permanent disease removal and for reducing the
risk of recurrent pathologic abnormality. Conclusions: Apart from material characteristics, the sound transmission

20
properties of the reconstructed tympanic membrane are strongly influenced footplate at the department of otorhinolaryngology, head and neck surgery
by the reconstruction technique. The choice of the surgical technique should at the University of Cologne over an 8-year period (2007–2015).
consider requirements based on mechanical stability and acoustic transfer
characteristics of the transplant. Main Outcome Measure: The use of the ‘‘sandwich cartilage shoe
technique’’ in case of a broken or unstable footplate allows a safe
occlusion of the open vestibule.
Experimental investigations of the use of cartilage in
tympanic membrane reconstruction Results: The statistical analysis revealed a significant improvement of the
pure-tone average (p = 0.011) and airbone gap (ABG) (p = 0.016) after
Zahnert T., Hüttenbrink K.-B., Mürbe D., Bornitz M. total ossicular replacement prosthesis (TORP) implantation. The hearing
was stable at 9 months of follow up.
Published: Am J Otol. 2000 May;21(3):322-8.
DOI: 10.1016/S0196-0709(00)80039-3 Conclusion: The sandwich cartilage shoe technique offers a safe and effec-
tive option as a two-stage procedure in treating patients with fractures of the
Background: Temporalis fascia, perichondrium, and cartilage are common- stapes footplate in case of chronic otitis media. In view of the possible risk of
ly used for reconstruction of the tympanic membrane in middle ear surgery. deafness going along with a destruction of an inner ear window, our results
Cartilage grafts offer the advantage of higher mechanical stability, partic- can be considered substantial as all our patients will at least be able to regain
ularly in cases of chronic tubal dysfunction, adhesive processes, or total ‘‘social hearing’’ as they all either achieved a hearing threshold is less than
defects of the tympanic membrane, in contrast to fascia and perichondrium, 30 dB or can be sufficiently supplied with a conventional hearing aid.
which presumably offer better acoustic quality.

Hypothesis: The purpose of this study was to determine the acoustic trans- Footplate Reconstruction: Preliminary Results
fer characteristics of cartilage of varying thickness and its mechanical de-
formation when exposed to fluctuations in atmospheric pressure. Rusiecka M., Bernal-Sprekelsen M.

Method: Ten pairs of cartilage specimens from the cavum conchae and the Published: Otol Neurotol 2014 Dec;35(10):1797-800
tragus were obtained from fresh human cadavers. Young's modulus was de- DOI: 10.1097/MAO.0000000000000467
termined by mechanical tension tests and statistically evaluated using the
t test. The acoustic transfer characteristics of an additional 10 specimens Introduction: A partially or fully absent or largely perforated footplate is a
were measured by a laser Doppler Interferometer after stimulation with challenging condition that may be encountered during middle ear surgery,
white noise in an external auditory canal--tympanic membrane model. Me- especially in patients with a history of chronic ear problems or with previ-
chanical stability was determined by measuring displacement of the carti- ous tympanoplasties.
lage using static pressure loads of ≤ 4 kPa.
Materials and Methods: Retrospective study on a limited number of cases
Results: Young's modulus determinations for conchal and tragal cartilage undergoing revision tympanoplasty in which a new footplate was created
were 3.4 N/mm2 and 2.8 N/mm2, respectively, but the difference was not from the cartilage, and the ossicular chain was reconstructed with a titanium
significant. Acoustic testing showed a 5-dB higher vibration amplitude in the prosthesis in 1 stage. Minimum follow-up was 24 months. Outcome mea-
midfrequency range for conchal compared with tragal cartilage, but the differ- surements included the preoperative and postoperative bone conduction to
ence was not significant. Reducing cartilage thickness led to an improvement assess the function of the inner ear, and the preoperative and postoperative
of its acoustic transfer qualities, with a thickness ≤ 500 microm resulting in threshold levels of air and bone conduction in 4 frequencies to assess the
an acceptable acoustic transfer loss compared with the tympanic membrane. possible hearing improvement.

Conclusion: Both conchal and tragal cartilage are useful for reconstruction Results: Six patients could be included. The audiologic results showed the
of the tympanic membrane from the perspective of their acoustic proper- average air conduction gain of 11 dB. We did not observe any significant de-
ties. The acoustic transfer loss of cartilage can be reduced by decreasing terioration in the bone conduction which, in some cases, even improved (av-
its thickness. A thickness of 500 microm is regarded as a good compromise erage change of +3 dB). The symptoms related to a perilymphatic fistula were
between sufficient mechanical stability and low acoustic transfer loss. resolved. The technique described herein has proven to be safe and reliable.

Conclusion: Reconstruction of the footplate with autologous cartilage and si-

multaneous type III tympanoplasty seems to be a promising solution for those
CARTILAGE PUNCH rare but challenging cases in which the footplate is partially of fully absent.

Long-term Follow-up Study of the Sandwich Cartilage Shoe The Sandwich Cartilage Shoe Technique for Ossicular
Technique in Cases of Insecure Stapes Footplate Reconstruction in a Case of an Unsecure Stapes Footplate

Lüers J. C., Schwarz D., Anagiotos A., Gostian A-O., Beutner Bremke M., Huettenbrink K.-B., Beutner D.
D., Hüttenbrink K.-B.
Published: Laryngoscope, 2011 Sep;121(9):1950-2.
Published: Otol Neurotol 37:e197–e202, 2016. DOI: 10.1002/lary. 21919
DOI: 10.1097/MAO.0000000000001093
This article describes a new surgical method for total ossicular reconstruc-
Objective: Analysis of the audiometric results after repair of a defective tion in case of a broken stapes fooplate. We developed the technique of
footplate with the sandwich cartilage shoe technique in a follow-up study. the “cartilage shoe sandwich”, which consist of two surgical steps. First,
the closure of the oval window is achieved by a cartilage shoe without a
Study Design: Retrospective analysis of audiometric data. Setting: Hospital. central perforation. During this surgical intervention, the prearrangement of
a secure placement of a total ossicular replacement prosthesis is provided
Patients: The cohort consisted of 12 patients, who underwent ossicular by a second cartilage with a central hole that is plugged with silicone. In a
reconstruction after sandwich cartilage shoe technique in a case of insecure staged procedure, the silicone plug is removed and the ossicular reconstruc-
stapes footplate. The mean age was 42.7 years with an equal sex distribu- tion can be performed. The audiological results of the first patients show a
tion. In every patient, cholesteatoma was the reason for surgery with 75% stable inner ear function with an air-conduction gain of 9 dB. The technique
being revision cases. described herein has proved to be safe and reliable in total ossicular recon-
struction in the event of an unsecure stapes footplate.
Intervention: Sandwich cartilage shoe technique in case of insecure stapes

21
Cartilage ‘shoe’: a new technique for stabilisation Neudert M., Bornitz M., Lasurashvili N., Schmidt U.,
of titanium total ossicular replacement prosthesis at centre Beleites Th., Zahnert Th.
of stapes footplate
Published: Otology & Neurotology: October 2016, Volume 37
Beutner D., Luers J. C., Hüttenbrink K.-B. Doi: 10.1097/MAO.0000000000001064

Published: J Laryngol Otol. 2008 Jul; 122(7):682-6. Hypothesis: Prosthesis’ length creates tension in ossicular reconstructions,
DOI: 10.1017/S0022215108002545 which directly effects the middle ear sound transmission. Background:
Relatively long prostheses are often used to stabilize the middle ear recon-
Objective: After tympanoplasty using a total ossicular replacement prosthesis, struction to prevent dislocation. Thereby, tension on the flexible compo-
many unsatisfactory hearing results are due to dislocation of the prosthesis. nents such as the tympanic membrane (TM) and the annular ligament (AL)
is increased. Only little is known on the amount of displacement-related
Material and Methods: We developed a cartilage guide for stabilising the stiffening of the TM and AL, as well as the consecutive reduction in middle
total ossicular replacement prosthesis in the oval window niche. An oval- ear transfer function (METF).
shaped piece of cartilage measuring 2.5 x 3.5 mm with a central hole was
precisely punched out of a thin cartilage plate. The cartilage was placed in Methods: An expandable total ossicular replacement prosthesis was ten-
the oval niche, and its hole centred the prosthesis on the stapes footplate. sionfree inserted in nine cadaveric temporal bones between the malleus
handle and the stapes footplate. Upon heat activation the prosthesis was
Results: Hearing results in 52 patients confirmed acoustically the effective- lengthened, thus inducing tension on the reconstruction. The METF was as-
ness of this method of total ossicular replacement prosthesis stabilisation sessed before and after elongation. TM's and AL's stiffness were determined
on the stapes footplate. Subsequent ‘second-look’ surgery revealed stable by measuring their force–displacement characteristics.
ingrowth of the cartilage ‘shoe’ into the oval niche.
Results: Upon activation the prostheses were elongated between 50 and
Conclusion: Such a cartilage shoe might address one of the causes of un- 200 μm. A frequency-dependent METF reduction was measured with a
satisfactory hearing following ossicular chain reconstruction with a total decrease of 5 to 25 dB below 1.0 kHz. At frequencies >2.0 kHz the reduc-
ossicular replacement prosthesis. tion was less prominent or the METF showed even an improvement of up
to 10 dB. TM's stiffness remained constant during the elongation-induced
displacement, whereas the AL's stiffness increased. The METF reduction
The Cartilage Guide: A solution for Anchoring below 1.0 kHz correlated with the increasing AL's stiffness.
a Columella-Prosthesis on Footplate
Conclusion: Tension has a significant impact on the METF after middle ear
Hüttenbrink K.-B., Zahnert Th., Beutner D., Hofmann G. reconstruction. As little tension as possible should be used to enable best
sound transmission. Stabilization of prosthesis should be achieved with dis-
Published: Laryngorhinootologie 2004; 83: 450-456. location devices to ensure secure coupling to the ossicular remnants without
DOI: 10.1055/s-2004-814447 creating additional tension.

Background: A torp (columella-prosthesis) is the typical ossicular recon-

struction in cases of a destroyed stapedial arch. Yet, many unsatisfactory Optimum tension for partial ossicular replacement prosthesis
hearing results are due to the lack of a stable, reliable anchoring of the base reconstruction in the human middle ear
of the prosthesis on the footplate. Some solutions have been postulated,
amongst them the perforation of the footplate with a tiny spike at the lower Morris D.P., Bance M., van Wijhe R.G., Kiefte M., Smith R.
end of the prosthesis, which, however, many otosurgeons regard as too dan-
gerous for the inner ear. Specially designed silicone sheets cannot guarantee Published: Laryngoscope. 2004 Feb;114(2):305-8.
a permanent guide of the columella. DOI: 10.1097/00005537-200402000-00024

Methods: From our good experience with cartilage in different reconstruc- Objective: Hearing results from ossiculoplasty are unpredictable. There are
tion procedures, we therefore developed a cartilage guide for the oval win- many potentially modifiable parameters. One parameter that has not been
dow niche. An oval 2,5 x 3,5 mm cartilage with a central hole is cut out of adequately investigated in the past is the effect of tension on the mechanical
a thin (0,2 - 0,3 mm) cartilage plate with a help of a cartilage punch, which functioning of the prosthesis. Our goal was to investigate this parameter fur-
we had designed in collaboration with Heinz Kurz manufacture. The carti- ther, with the hypothesis that the mechanical functioning of partial ossicular
lage is placed into the oval niche and its hole guides the prosthesis onto the replacement prostheses (PORP) from the stapes head to the eardrum will be
centre of the footplate. affected by the tension that they are placed under.

Results: Temporal bone experiments demonstrated a reliable sound transport Methods: Fresh temporal bones were used to reconstruct a missing incus
through this guide. Revision surgery revealed a stable ingrowth of the carti- defect with a PORP-type prosthesis. Three different lengths of PORP were
lage plate into the oval niche, its perforation securely guiding the prosthesis used, and the stapes vibrations were measured with a laser Doppler vibro-
similar to a piston on to the footplate. The first short time hearing results meter using a calibrated standard sound in the ear canal. Eight temporal
(max. 1 year) in 22 patients confirmed the acoustic quality of this stabilisa- bones were used.
tion of a columella on the footplate as compared to a matched control group.
Results: Tension had a very significant effect on stapes vibration. In gen-
Conclusion: The stabilization of the columella with a cartilage-guide might eral, loose prostheses resulted in the best overall vibration transmission.
solve one of the many problems with unsatisfactory hearing results after the The effects were most marked at the lower frequencies. There was a slight
reconstruction of a completely destroyed ossicular chain. advantage to tight prostheses in the higher frequencies, but much less than
the decrement in lower frequencies with tight prostheses.

Conclusion: In ossicular reconstruction, best stapes vibration results in our

TENSION model are achieved by shorter prostheses, which result in lower tension.

Impact of Prosthesis Length on Tympanic Membrane's Comparison of the mechanical performance

and Annular Ligament's Stiffness and the Resulting Middle Ear of ossiculoplasty using a prosthetic malleus-to-stapes
Sound Transmission head with a tympanic membrane-to-stapes head assembly
in a human cadaveric middle ear model

22
Bance M., Morris D.P. Vanwijhe R.G., compared with rigid TORP. In average, it provides an equivalent sound
Kiefte M., Funnell W.R. transfer like the intact middle ear. At positive pressure, the flexible TORP
performs slightly worse. Both performed worse than the intact middle ear,
Published: Otol Neurotol. 2004 Nov;25(6):903-9. which is related to an uplifting of the prostheses.

Hypothesis: Ossiculoplasty using prosthetic reconstruction with a malleus Conclusion: The findings may be considered preliminary as this experi-
assembly to the stapes head will result in better transmission of vibrations mental study was limited to just one of the many different possible situa-
from the eardrum to the stapes footplate than reconstruction with a tympan- tions of tympanoplasty and it involved a small sample size. Nevertheless,
ic membrane assembly to the stapes head. Both types of reconstruction will the results with the flexible TORP were promising and could encourage
be affected by tension of the prosthesis. further investigations on such prostheses.

Background: Theories (and some clinical studies) that the shape of the nor-
mal tympanic membrane is important suggest that prosthetic reconstruction Comparison of the functional results of partial and total
to the malleus performs better than reconstruction to the tympanic mem- prostheses with chronic otitis media
brane. This has not been previously tested by directly measuring vibration
responses in the human ear. Our previous work suggests that tympanic Dombrowski T., Minovi A., Dazert S.
membrane assembly to the stapes head type prostheses performed best un-
der low tension. This had not been previously tested for malleus assembly Published: 86th Annual Meeting of the German Society for Oto- Rhi-
to the stapes head type prostheses. no- Laryngology, Head and Neck Surgery e.V. Berlin, May 13-16, 2015.
Meeting Abstract (German). DOI: 10.3205/15hnod328
Methods: Hydroxyapatite prostheses were used to reconstruct a missing
incus defect in a fresh cadaveric human ear model. Two types of prostheses Surgical treatment of chronic otitis media often requires not only reliable
were used, one from the stapes head to the malleus (malleus assembly to reconstruction of the tympanic membrane but also restoration of the ossi-
the stapes head), the other from the stapes head to the tympanic membrane cle chain for sound transmission. The combination of autologous cartilage
(tympanic membrane assembly to the stapes head). Stapes footplate center with a partial (PORP) or total prosthesis (TORP) of titanium is one of the
responses were measured using a laser Doppler vibrometer in response to most common surgical methods. The objective of the study was a differen-
calibrated acoustic frequency sweeps. tial comparison of both types of prosthesis with reference to the functional
results. We evaluated the results of 199 patients who were operated on in
Results: Tension had a very significant effect on both types of prostheses in our hospital for chronic epitympanal or mesotympanal otitis media from
the lower frequencies. Loose tension was best overall. The malleus assem- 2006 to 2013 in a retrospective, exploratory data analysis.
bly to the stapes head type prostheses consistently performed better than
the tympanic membrane assembly to the stapes head type prostheses when The TORP group experienced significantly poorer preoperative and post-
stratified for tension. operative conductive hearing loss (CHL) but higher average postoperative
reduction of the CHL. The best hearing improvement for the PORP group
Conclusion: Tension has a significant effect on prosthesis function. Mal- was at 0.5kHz (7.93dB average reduction of CHL), and the worst at 4kHz
leus assembly to the stapes head type prostheses generally result in better (4.06dB). After TORP implantation there was an average reduction of the
transmission of vibrations to the stapes footplate than tympanic membrane CHL at frequencies between 8.37dB (3kHz) and 10.53dB (4kHz).
assembly to the stapes head type prostheses.
The functional result of the PORP showed no connection to the postop-
erative observation period. At TORP implantation the CHL improved,
significantly in some cases, after more than 6 months. A regular and sig-
T O TA L A N D PA R T I A L R E C O N S T R U C T I O N nificant hearing improvement can be achieved with both prostheses. In the
low-frequency range the PORP achieved a significant hearing improve-
ment, while the TORP appeared to have advantages above 25dB particu-
Function, Applicability, and Properties of a Novel larly with revision operations and preoperative CHL. The hearing result
Flexible Total Ossicular Replacement Prosthesis With a with PORP prostheses with increased follow-up time showed no change,
Silicone Coated Ball and Socket Joint while after TORP implantation hearing results were improved in all
frequencies after more than 6 months.
Stoppe T., Bornitz M., Lasurashvili N., Sauer K.,
Zahnert T., Zaoui K., Beleites T.
Cartilage Palisades in Type 3 Tympanoplasty:
Published: Otol Neurotol. 2018 Jul;39(6):739-747. Functional and Hearing Results
DOI: 10.1097/MAO.0000000000001797
Vashishth A., Mathur N. N., Verma D.
Hypothesis: A total ossicular replacement prosthesis (TORP) with a sil-
icone coated ball and socket joint (BSJ) is able to compensate pressure Published: Indian J Otolaryngol 09/2014, Volume 66, Issue 3, pp 309 - 313.
changes and therefore provide better sound transmission compared with DOI: 10.1007/s12070-014-0717-3
rigid prostheses.
To evaluate the functional and hearing outcomes using full thickness broad
Background: Dislocation and extrusion are known complications after cartilage palisades for tympanic membrane reconstruction in type 3 tympa-
TORP reconstruction, leading to revisions and recurrent hearing loss. Poor noplasty with titanium prostheses. The retrospective study performed at a
aeration of the middle ear, scar tension, and static pressure variations in tertiary referral institute included 30 patients with posterior mesotympanic
conjunction with rigid prosthesis design causes high tension at the implant retraction pockets or tympanic membrane perforations requiring tympanic
coupling points. membrane and type 3 ossicular reconstruction. Patients with disease extend-
ing beyond the aditus requiring canal wall down mastoidectomy were ex-
Methods: A novel TORP prototype with a silicone coated BSJ has been cluded. Disease removal from posterior mesotympanic and epitympanic re-
developed. Experimental measurements were performed on nine fresh ca- cesses was confirmed using angled endoscopy and ossicular reconstruction
daveric human temporal bones of which five were used for a comparison was performed using titanium partial or total ossicular replacement pros-
between rigid TORP and flexible TORP tympanoplasty. The middle ear theses. Tympanic membrane reconstruction was done, with or without attic
transfer function was measured at ambient pressure and at 2.5 kPa, both reconstruction, using full thickness broad cartilage palisades harvested from
positive and negative pressure, applied in the ear canal. the tragus with perichondrium attached laterally. Patients were assessed at
24 and 48 weeks for graft status and any evidence of implant extrusion.
Results: The flexible TORP design yields a better transmission of sound Hearing evaluation was done using subjective assessment and pure tone
after implantation and at negative pressure inside the tympanic cavity, audiometry. In total, 27 out of 30 patients had intact and completely healed

23
grafts at 48 weeks postoperatively (a success rate of 90 %) showing full and patients follow up. All patients included in the study had a minimum
union and epithelialization of palisades, and with three patients displaying follow up of 6 months.
small defects. The mean pure tone air bone gap pre- and postoperatively
was 32.4 and 8.8 dB, respectively, with most patients reporting satisfactory The aim of the study was to analyse the audiological results of different
postoperative hearing. No evidence of implant extrusion was found in the grafting materials, which werecombined with ossicular chain reconstruc-
48-week period. Tympanic membrane reconstruction using full thickness tion. In general, the audiological results achieved in ears which needed a
palisades of tragal cartilage provides good functional and hearing outcomes tympanoplasty type I or III showed postoperatively for 80 % of the patients
in type 3 tympanoplasty with titanium prostheses. an improved hearing compared to preoperatively. The best hearing results
were achieved in those ears in which primary tympanoplasty type I was per-
formed without ossicular chain reconstruction (type I tympanoplasty). The
A micro-computed tomographic study: determination of the grafting materials we used (perichondrium, cartilage palisades, perichondri-
angle between the tympanic membrane and stapes footplate umcartilage composit graft (PCCG)) showed 6 months postoperative a sim-
in a total ossicular reconstruction prosthesis reconstruction ilar air bone gap. The audiograms were measured for the frequencies from
0.5 kHz to 8 kHz. Hearing results were best at 2 kHz. As expected, those
Herkenhoff S., Fischer B., Gleich O., Strutz J., Kwok P. patiens who requiered type III TORP tympanoplasty enjoyed less hearing
recovery than those who required a type I tympanoplasty or a PORP.
Published: Otol Neurotol. 2011 June; 32(4): 610-5
DOI: 10.1097/MAO.0b013e318213af4d Perichondrium and the cartilage techniques led to simular results. It should
not be unmentioned that repreferations occured. The perforation closure
Objectives: To examine the anatomical relationship of the angles between rate in type III tympanoplasties was 92.3%, the total repreferation rate was
tympanic membrane and stapes footplate and the variation of these angles 7.7 %. Based on temporal bone studies using a laser doppler vibrometer also
among different temporal bones in order to characterize the optimal shape the influence and the audiological quality of different middle ear protheses is
of total ossicular reconstruction prostheses (TORPs). discussed. The results of the temporal bone study as well as the initial clinical
findings using a new light titanium (n=396) prostheses are discussed. Not
Methods: Ten specimens of human temporal bones were prepared for surprisingly the combination or different graft materials and different proth-
examination with micro-computed tomography. Five of the 10 temporal eses led to similar clinical results except in type III TORP tympanoplasty.
bones were implanted with 3 types of TORPs before subjecting them to In these type of tympanoplasty with a reconstruction of the ossicular chain
micro-computed tomography. The angles between tympanic membrane and between stapes footplate and reconstructed eardrum significant better results
stapes footplate were determined. The contact of the TORPs to these struc- were obtained when using cartilage. Based on our data we can conclude that
tures was assessed. tympanoplasty nowadays is able to improve the hearing.

Results: The angle between the stapes footplate and the tympanic mem-
brane was, on average, 25.9 degrees in a plane along the transverse axis of
the stapes footplate and 24.6 degrees in a plane along the longitudinal axis T I TA N I U M A N D O T H E R M AT E R I A L S
of the stapes footplate. Consideration of these angles in TORPs resulted in
an optimal contact with the tympanic membrane and stapes footplate, espe-
cially for prostheses with a large foot. Biocompatibility of nitinol stapes prosthesis

Conclusion: TORPs should be adjusted in shape before insertion into the mid- Roosli C., Schmid P., Huber A.M.
dle ear. Further developments should consider prostheses with preadjusted an-
gles or appliances for the exact modification of the prostheses during surgery. Published: Otol Neurotol. 2011 Feb;32(2):265-70.
DOI: 10.1097/MAO.0b013e318201622e.

Germany Tympanoplasty today - an analysysis of 11000 cases Objective: Use of the SMart piston, a nitinol-based, self-crimping prosthe-
of reconstructive middle ear surgery - the Würzburg experience sis in stapes surgery may allow improved functional results because of bet-
ter sound transmission properties at the incus-prosthesis interface because
Müller J., Schön F., Brill S., Helms J., Hagen R. of the elimination of manual crimping. Possible disadvantages include ther-
mal damage or strangulation of the incus and its mucoperiosteum or nickel
Published: MEMRO 2006, 4th International Symposium on Middle Ear intolerance. The goal of this study was to morphologically assess the fixa-
Mechanics in Research and Otology: Selected Abstracts. tion of this prosthesis to the incus, investigate the reaction of the middle ear
mucosa to the prosthesis, identify alterations to the incudal bone, and detect
Nowadays middle ear surgery is not only done to treat mastoiditis and to deposits of nickel in the tissue around the prosthesis.
prevent its complications, which are highly dangerous. Middle ear surgery
is also done to restore the hearing. Ojala summed up the situation in the sev- Study Design: Prospective consecutive case analysis. Setting: Tertiary
enties when he stated that „hearing after tympanoplasty usually does not im- referral center. Patients: Four patients with an unfavorable functional
prove (and in some cases even deteriorates)“. Since Wullstein (Würzburg) result after primary SMart-piston stapedotomy. Intervention: Revision
discribed the basic principles of tympanoplasty in the early 50ties, many malleostapedotomy with explantation of the incus and prosthesis for further
other otologists made additional contributions to our current knowledge of analysis.
tympanoplasty. The aims of tympanoplasty have been and still are:
Main Outcome Measures: Analysis of intraoperative findings and post-
• the elimination of the pathological changes operative examination of the explants using light- and scanning-electron
• to create stable conditions and easy access for postoperative care microscopy, energy dispersive x-ray analysis, and atom absorption spec-
• to reconstruct the sound conduction mechanism. trometry.

Numerous grafting materials have been recommended for the closure of Results: The intraoperative, macroscopic, and scanning electron micro-
tympanic membrane perforations. This paper evaluates three different graft- scopic investigation showed tight circular fixation of the prostheses, where-
ing materials for the reconstruction of the tympanic membrane: as a gap between the prosthesis and the lateral incus was found in 1 case. All
• Pericondrium prostheses were overgrown by mucosa. Superficial localized erosion of the
• Cartilage incudal bone was found in 2 cases. There was no elevation in nickel content
• Perichondrium-Cartilage Composite Graft in the removed tissue samples.

The study is based on a computerized documentation system called „Würz- Conclusion: The lateral gap between prosthesis and incus did not affect
burger Ohrbogen“. This system includes now more than 11000 patient’s fixation of the prosthesis, neither did covering by a mucosal layer. Bone ero-
records. The database comprises information on surgical details (324 items) sion was most likely caused by laser in one and by the prosthesis in another

24
explant. No signs of increased nickel deposits could be found on energy perior to those of nontitanium prostheses when evaluated within 6 months
dispersive x-ray analysis or atom absorption spectrometry. We conclude that after ossiculoplasty.
a nitinol stapes prosthesis is safe for treatment of stapedial fixation.

Surgical-handling properties of the titanium prosthesis

Titanium versus autograft ossiculoplasty in ossiculoplasty

Fong J. C., Michael P., Raut V. Maassen M. M., Löwenheim H., Pfister M., Herberhold S.,
Jorge J. R., Baumann I., Nüsser A., Zimmermann R.,
Published: Acta Otolaryngol. 2010 May;130(5):554-8 Brosch S., Zenner H.-P.
DOI: 10.3109/00016480903338131
Published: Ear Nose Throat J. 2005 Mar;84(3):142-4, 147-9.
Conclusion: In this comparative series, hearing results were superior with
titanium compared with autograft ossiculoplasty in the absence of a stapes Despite the wide variety of ossiculoplasty techniques that are available, suc-
superstructure. However, in the presence of a stapes superstructure, titanium cess rates are limited. Current use indicates that surgeons prefer ceramic,
ossiculoplasties gave superior results to autografts only when comparing an autograft bone, and plastic pore prostheses. During the past decade, tita-
air-bone gap of < 10 dB. nium prostheses have been used with great promise. Although their use is
not widespread, satisfaction rates are high. An earlier study of ossiculoplas-
Objective: To compare the hearing outcomes of autograft versus titanium ty showed that titanium prostheses were effective in reducing conductive
ossiculoplasty at 1 year. hearing loss. To date, the surgical-handling attributes of titanium middle ear
prostheses have not been assessed. We report the results of our survey of
Methods: Two consecutive groups of patients with chronic suppurative 32 otologic surgeons who used the open Tubingen titanium prosthesis for
otitis media with and without cholesteatoma suitable for ossiculoplasty, primary and revision ossiculoplasty during tympanoplasty in 400 patients at
either primarily or as a staged procedure, were recruited for the study. 12 academic and nonacademic otolaryngology clinics, most of them in Ger-
A total of 52 consecutive patients who underwent an autograft ossicu- many. Because the audiometric efficacy of titanium prostheses has been pre-
loplasty were compared with 51 consecutive patients who underwent a viously reported, our primary outcomes measures included ease of use with
titanium ossiculoplasty. Hearing results were statistically compared at 1 respect to the amount of time required to prepare the implants for placement
year between the two groups using the four frequency average (FFA) of and the surgeons' overall impression of the intraoperative handling charac-
0.5/1/2/4 kHz and the American Academy of Otolaryngology-Head and teristics of the implants, taking into consideration factors such as positioning,
Neck Surgery (AAO-HNS) four frequency average of 0.5/1/2/3 kHz. The length adjustment, visibility, and the stability of the coupling. Surgeons also
results were analysed statistically. compared the properties of the titanium implant with those of gold, ceramic,
and autograft implants that they had used in the past. Based on the results of
Results: A statistically significant number of titanium TORP ossiculoplas- 383 of the 400 ossiculoplasties, our survey revealed that the titanium implant
ties achieved an air-bone gap closure to within < 20 dB compared with was significantly superior to the others in all measured respects.
the autograft equivalent group (p = 0.039 FFA; p = 0.016 AAO-HNS). The
number of titanium PORP ossiculoplasties achieving an air-bone gap clo-
sure to within < 10 dB compared with the autograft equivalent group was Ossicular Reconstruction with Titanium Prosthesis
also statistically significant (p = 0.006 FFA; p = 0.002 AAO-HNS).
Martin A. D., Harner S. G.

Titanium versus Nontitanium Prostheses in Ossiculoplasty Published: Laryngoscope 114(1):61-64 January 2004
DOI: 10.1097/00005537-200401000-00010
Coffey Ch., S., Lee F.-S., Lambert P. R.
Objectives: To evaluate the results when using titanium total ossicular re-
Published: Laryngoscope 118: September 2008, 1650-1658 placement prosthesis (TORP) or partial ossicular replacement prosthesis
DOI: 10.1097/MLG.0b013e31817bd807 (PORP) in chronic ear disease.

Objectives/Hypothesis: To compare the hearing outcomes and complica- Study Design: Retrospective chart review was performed.
tions observed using either titanium or nontitanium prostheses in a 7-year
consecutive series of ossiculoplasties performed by a single surgeon. Methods: Sixty-eight ossicular procedures using a titanium TORP (n = 30)
or PORP (n = 38) were performed at a tertiary referral center between De-
Study Design: Retrospective. cember 1999 and June 2002. The ossiculoplasty was performed either alone
or in combination with other chronic ear surgery. Cartilage grafts were
Methods: A database of ossicular reconstruction surgeries was reviewed used universally. Nineteen percent were primary operations, and 6% were
for preoperative and postoperative audiometric data including air and bone planned second stages. The majority were revision procedures. Follow-up
conduction thresholds at four frequencies and speech reception thresholds. ranged from 3 months to 2.5 years.
Outcomes were evaluated at time points less than and greater than 6 months
postoperatively. Baseline demographic and surgical characteristics and Results: The prosthesis is easy to insert, well tolerated, and has a low ex-
postoperative complications were also noted. trusion rate. Average air-bone gap (ABG) improvement was 13 dB with clo-
sure of the ABG to within 20 dB in 57% of cases. Hearing results were bet-
Results: A total of 105 cases had sufficient audiometric data available ter for primary versus revision cases for PORPs versus TORPs and for intact
for analysis, including 80 performed with titanium and 25 with nontitani- canal wall (ICW) procedures versus canal wall-down (CWD) procedures.
um implants. Follow-up ranged from 1.2 to 74.2 months, with a mean of
14.9 months. Mean air-bone gap at initial follow-up was 21.7 dB in the Conclusion: Titanium is a satisfactory material for use in ossicular recon-
nontitanium group and 15.4 dB in the titanium group; this difference was struction because of its ease of insertion, tissue tolerance, and low rate of
significant (P = .01). Postoperative air-bone gap of less than 20 dB at initial extrusion. Caution is advised when selecting candidates for this procedure
follow-up was achieved in 50.0% of nontitanium cases and 77.1% of tita- during revision surgery, especially if the canal wall and stapes superstruc-
nium cases (P = .012). This difference in "success" rates persisted at longer ture are absent.
follow-up but did not achieve statistical significance. Mean speech recep-
tion thresholds at <6 months was 29.7 dB in the nontitanium group and 22.6 119. Anatomical and functional results of titanium
dB in the titanium group (P = .049). Extrusion was observed with two non- prostheses in middle ear ossiculoplasty
titanium prostheses (8.0%) and three titanium prostheses (3.8%) (P > .05).
Gerard J.M., Blaivie C., Decat M., Garin P., Gersdorff M.
Conclusions: Titanium ossicular prostheses provide hearing outcomes su-

25
Published: 24th Politzer Society Meeting 31 August – 4 September 2003, ation. The present report offers a treatment plan for a group of patients requir-
Amsterdam, the Netherlands: Selected Abstracts ing reconstruction of the entire ossicular conduction mechanism including
removal of the stapes footplate. Study Design: Retrospective review.
In the majority of chronic middle ear disease, there is an ossicular chain
defect. Various types of prostheses are used for ossiculoplasties. The most Methods: Three thousand three hundred fifty (3350) charts of patients
common are autogenous or allogenous bone or cartilage, plastipore. hy- requiring total ossicular replacement prostheses (TORPs) were reviewed. Of
droxyapatite, bioactive glass and many other prostheses. Since a few years this group of patients, only 21 of 3350 patients from 1977 to 1999 required
different metals were also available, like gold and titanium. Between No- TORP placement and removal of the stapes footplate. The patients were
vember 1997 and January 2003, 77 patients were operated for chronic ear followed for an average period of 50 months.
disease. Two types of titanium ossicular prostheses were used for ossicu-
loplasties (40 Spiggel and Theis® and 37 Kurz®). We performed interpo- Results: Hearing results indicated an overall improvement in the air-bone
sitions of the tragal or allograft cartilage. The mean age was 41 years old gap of 10 dB, with 52% achieving an air-bone gap of less than 20 dB.
and the average follow- up was 31 months for the Spiggel and Theis® and Of the 21 cases, 5 revision surgeries were performed. Three were performed
5 months for the Kurz®. We used 43 total ossicular prostheses (TORP) and because of a displaced TORP (14.2%). and 2 were performed because of
34 partial (PORP). One patient had a prosthesis extrusion after a postop- extruded TORPs (9.5%).
erative infection. All others had stable anatomical results. The pure tone
average air-bone gap (PTA-ABG) was calculated on 500,1000, 2000 and Conclusions: Reconstruction of the entire ossicular conduction mechanism
4000 Hz in preoperative and at the last postoperative consultation. For including removal of the stapes footplate can be successfully achieved with
the TORPs, the PTA-ABG ≤ 20 db was found in 55% of the cases for the improvement of the air-bone gap of less than 20 dB. Hearing results and
Spiggel and Theis® and 63% for the Kurz®. For the PORPs it was 54% extrusion rates are comparable to reported results of TORP placement on a
for the Spiggel and Theis® and 71 for the Kurz®. mobile footplate. Successful stapedectomy and simultaneous ossicular chain
reconstruction can be performed as a single or staged procedure. Special
Titanium ossicular prostheses offer advantages compared to other prosthe- attention is paid to avoid intrusion of the prosthesis into the vestibule.
ses having a very easy and simple surgical manipulation, excellent anatom-
ical stability and good functional results The Kurz® prostheses procured us
better functional results because of the sizer prostheses set which permits a Revision Ossicular Reconstruction with the
better evaluation of the height and the right position of the prosthesis. Titanium Kurz Prosthesis

Downs B. W., Pearson J. M., Zdanski C. J.,

Early Results With Titanium Ossicular Implants Buchman C. A., Pillsbury H. C.

Ho S. Y., Battista R. A., Wiet R. J. Published: Laryngoscope 112: August 2002

DOI: 10.1097/00005537-200208000-00002
Pubished: Otology & Neurotology, March 2003; 24(2): 149 - 152
Objectives/Hypothesis: One European multicenter study has reported
Objective: To report the efficacy of titanium middle ear prosthesis for os- favorable outcomes after ossicular reconstruction with the titanium Kurz
sicular reconstruction. Study Design: Retrospective chart reviews were per- prosthesis. At the time of this study, however, no study has analyzed its
formed for 25 patients who had undergone titanium ossicular implants be- outcomes when used for reconstruction after prior failure with another
tween January 1, 1999, and June 1, 2001. Setting: Tertiary otology referral implant (revision reconstruction). The study reports our experience with
center. Patients: All patients had a minimum of 6 months of postoperative the titanium Kurz prosthesis for revision ossicular reconstruction. Study
follow-up and no evidence of recurrent otologic disease. Intervention: All Design: A retrospective review was made of all revision ossicular recon-
patients had undergone ossiculoplasty using titanium middle ear implants. structions at our institution from October 1998 to September 2001.

Main Outcome Measures: Comparisons of preoperative and postoperative Methods: Seventeen cases were reviewed. Patients were divided into two
pure tone averages were performed. Air-bone gap closures and implant ex- groups: patients who underwent revision ossicular reconstruction with the Kurz
trusion rates were measured. prosthesis and patients who underwent revision ossicular reconstruction with an-
other prosthesis (the "other" group). Audiograms were reviewed and air-bone
Results: Overall mean pure tone averages improved 22.2 dB with air-bone gaps were calculated for each patient.
gap improvement at 20.9 dB. Fifty-six percent of patients achieved air-bone
gap less than 20 dB postoperatively. The overall extrusion rate was 4%. Results: The average postoperative air-bone gap after Kurz revision was
However, with the placement of cartilage graft interposed between the pros- 15.6 dB, a statistically significant improvement over the average postoperative
thesis and the tympanic membrane, no extrusion was observed. air-bone gap from the "other" revision group (P =.022).

Conclusion: Titanium implants provide comparable hearing improvement Conclusions: The titanium Kurz prosthesis has been an effective implant at
compared with other materials. The extrusion rate seems quite low if cartilage our institution for revision ossicular reconstruction. Future research should
interposition graft is inserted. Its ease of handling, biocompatible properties, focus on a prospective, randomized trial comparing the Kurz prosthesis with
and sound conducting properties improve its efficacy as an ossicular implant. other prostheses currently in use.

Reconstruction of the entire ossicular conduction mechanism Titanium as a material for ossicular replacement –
basic aspects and clinical application
Battaglia A., McGrew B. M., Jackson C. G.
Schwager K.
Published: Laryngoscope, 113:654-658: April 2003
DOI: 10.1097/00005537-200304000-00013 Published: Laryngorhinootologie 2002 Mar; 81 (3):178-83. (German)
DOI: 10.1055/s-2002-25037
Objectives/Hypothesis: Stapes fixation combined with fixation, absence, or
malformation of the malleus-incus complex requires an uncommon surgical Background: The use of titanium as a biomaterial in ossicular chain recon-
reconstruction and offers a unique combination of challenges and hazards. struction is increasing. The situation for integration of biomaterials is more
This situation may occur in the presence of severe tympanosclerosis, oto- difficult in the semiopen implantation site middle ear than in other parts of the
sclerosis, congenital ossicular malformations, and revision surgery for either body. Important for integration is the contact of the biomaterial's surface to-
stapedectomy or chronic ear disease. In previous reports, this procedure has ward proteins. Studies of the integration in living tissue still have to be performed
been grouped with total ossicular reconstruction without much distinction. in animal experiments. Morphological examinations of explanted prostheses af-
However, the challenges unique to this problem deserve special consider- ter clinical use complete the picture of an ossicular replacement material.

26
Methods: Preclinical studies where performed to compare the adsorption the wire from the ventilation tubes moved during vibration of the Petri dish.
behaviour of titanium, stainless steel and aluminum oxide toward radio- With exception of two implants, all implants changed positions in the water
active marked albumin and native collagen type I. An animal model in the bath. In the swim test, the gold implants showed the least movement of all
rabbit was performed to study the integration of titanium in the middle ear the implants. In this study, the properties of the non-ferromagnetic implant
morphologically. Middle ear prostheses removed during revision surgery materials differed in the 7 Tesla MRI. Stainless steel ventilation tubes, the
were studied as well. trachea support ring and the nose dilatator were not suited for the 7 Tes-
la MRI system, because they changed their position during MRI. In the
Results: Titanium showed an adsorption amount of 360 microgram/cm(2), case of ventilation tubes with a steel wire, the wire should be removed
stainless steel of 230 microgram/cm(2) and aluminum oxide of 500 micro- before MRI to prevent injury to the external auditory canal. There was a
gram/cm(2) out of an albumin solution of 400 mg/ml. Comparing desorption tendency for the pure gold implants to move less in the 7 Tesla MRI than
the mean loss was 16 % for titanium, 21 % for stainless steel and 23 % for al- all other tested materials. General statements cannot be made about the
uminium oxide. Reassembled collagen fibrils could be detected after adsorp- MRI suitability of different implants. Every implant should be individually
tion in collagen type I solution by means of scanning electron microscopy. examined to confirm its definitive MRI compatibility. Particularly, middle
Morphological studies in animal experiments showed regular healing after ear implants warrant special attention here due to their closeness to the
implantation. Explanted prostheses from humans did not show any cellular oval window.
signs of repulsion.

Conclusion: The results of preclinical studies and clinical use demonstrate Safety evaluation of titanium middle ear prostheses at 3.0 tesla
titanium as a useful material for ossicular reconstruction in middle ear
surgery. Martin A. D., Driscoll C. L., Wood C. P., Felmlee J. P.

Published: Otolaryngol Head Neck Surg 2005 Apr;132(4):537-42.

Titanium as an ossicular replacement material: results after
336 days of implantation in a rabbit Objective: To assess the magnetic resonance imaging (MRI) safety of tita-
nium middle ear prostheses at 3.0 tesla (T).
Schwager K.
Study Design and Setting: Titanium middle ear prostheses from 3 com-
Published: Am J Otol. 1998 Sep; 19(5):569-73 mercial vendors were examined for magnetic field interactions at 3 T.
Initially, ex vivo studies were performed to test for rotational motion and
Objective: Titanium in other parts of the body, well known for its biocom- forward displacement (translational motion) of the prostheses in a static
patibility, was examined in an animal model for its use as an ossicular re- magnetic field. If movement was observed during this screening study, then
placement material. the prosthesis was tested to determine the translational or rotational force
acting upon the prosthesis. In addition to testing for prosthesis displace-
Study Design: The biocompatibility of titanium was studied in the middle ment, temperature changes of the prostheses were measured to assess for
ear of rabbits using light and scanning electron microscopy. Titanium pins radiofrequency heating during imaging.
were placed as middle ear prostheses or as free implants and were examined
after 28, 84, 168, and 336 days. Results: Twenty-one of the 24 titanium prostheses tested revealed no move-
ment when tested in the 3 T static magnetic field. Three prostheses revealed
Results: After 28 days, the prostheses were covered by regular mucosa. The minimal movement during the screening study. A translational force test
free implants took up to 336 days to be totally epithelialized. There were no (string test) was performed upon these 3 prostheses, and the measured an-
inflammatory cells observed on the surface of the material nor were unusual gle of displacement was used to determine the force. This calculated force
amounts of fibrous tissue seen. In addition, the titanium material exhibited acting upon each prosthesis was essentially zero. Therefore, we conclude
an affinity toward bone. that the magnetic field interaction is negligible. A positive control with a
ferromagnetic stainless steel prosthesis demonstrated obvious displacement
Conclusions: The results of this animal experiment indicate that titanium is during the screening study, as well as deflection of the prosthesis by 90 de-
a useful material for ossicular replacement prostheses. grees in the translational force test. Last, heating of the titanium prostheses
did not occur in the 7 models tested.

Conclusions: Middle ear prostheses made from titanium are safe,

MRI neither deflecting nor heating during magnetic resonance examinations
conducted at 3 T.

Behavior of metal implants used in

ENT surgery in 7 Tesla magnetic resonance imaging
COUPLING OSSICULOPLASTY
Thelen A., Bauknecht H. C., Asbach P., Schrom T.

Published: Eur Arch Otorhinolaryngol. 2006 Oct;263(10):900-5. Coupling problems in middle ear reconstruction
DOI: 10.1007/s00405-006-0082-2
Zahnert T.
Magnetic resonance imaging (MRI) has become increasingly important as
an imaging technique in cross-sectional imaging of head and neck diseases. Published: MEMRO 2006, 4th International Symposium on Middle Ear
To investigate whether MRI examinations can be performed without risk in Mechanics in Research and Otology: Selected Abstracts.
patients with metal implants even at higher field strengths, we examined
different materials in 7 Tesla MRI. Implants near sensory organs like the The normal and reconstructed middle ear can be considered as a mechani-
middle ear or eye are of particular interest here. Using the 7 Tesla research cal vibrating system. After the implementation of tympanoplasty as a stan-
MRI for small animals, we tested implants made of various metals like dardized surgical technique various reconstruction techniques and implants
titanium, gold, gold/platinum, platinum/iridium, gold-plated silver, PTFE were suggested for the reconstruction of the tympanic membrane and the
and stainless steel for heating, translocation and rotation according to a ossicular chain. Laser–Doppler-vibrometry and model calculations have
standardized protocol. A fiber optic temperature probe measured the heat- given new insight into the vibration modes of the normal and reconstructed
ing of the implant before, during and after MRI scanning. None of the im- middle ear during the recent years. Nowadays it can be concluded, that
plants showed significant heating. The gold-plated stainless steel ventilation not only material properties of implants but also coupling factors have an
tube was the only implant to markedly change its position already in the Petri important influence on good hearing results. We investigated coupling fac-
dish. Of the remaining implants, a trachea support ring, a nose dilatator and tors between tympanic membrane and the surrounding bone, between the

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tympanic membrane and middle ear implants and between the prosthesis
and the ossicular chain using model calculations and temporal bone ex-
periments.

The quality of the tympanic membrane, which can be considered as the “mo-
tor of the middle ear”, has the most important impact on the sound transfer
to the inner ear. Ventilation and mucosa problems can damp the tympanic
membrane vibrations as well as the reconstruction techniques or the me-
chanical properties of transplants. The coupling of the tympanic membrane
to either the surrounding bone or the cartilage transplants has an influence
on the stiffness. The contact of the tympanic membrane to the malleus han-
dle is of importance in order to allow good sound conduction to middle ear
prostheses in the high frequency range.

Furthermore the contact of prostheses to the stapes head or the footplate may
influence hearing results. In our investigations the angle of prostheses to-
wards the tympanic membrane and the stiffness of coupling plays an import-
ant role. Concerning the angle it is of importance to distinguish between the
x and y – direction. An absolutely stiff contact between malleus and stapes
can reduce the sound transfer and increase the risk of prosthesis dislocation
or even damage of the annular ligament. Even nowadays modern middle ear
reconstructions can only simulate the simple function of a columella. In fu-
ture it may be important to invent middle ear implants which will be able to
fulfill both required middle ear functions – the sound transfer and the com-
pensation of atmospheric pressure changes. It can be assumed that hearing
results may improve due to an unstressed coupling of middle ear prostheses
by taking the above mentioned techniques and findings into consideration.

V E N T I L AT I O N T U B E S

Infection frequency and type of bacteria after

tympanostomy tube drainage in childhood: gilded-silver
tubes versus silicone tubes

Schmäl F., Nieschalk M., Delank K.W., Stoll W.

Published: HNO 1999 Feb; 47 (2):107-111.

Otorrhea is the most common complication after tympanostomy tube in-

sertions. In Germany there are currently two commonly used types of tym-
panostomy tubes: silicon tubes (ST) and gilded silver tubes (GT). Previ-
ously published in vitro studies by Tajima uncovered a positive correlation
between the silicon concentration in culture fluid and the rate of growth
of Staphylococcus aureus. Our study retrospectively evaluates the types of
bacteria and rates of otorrhea after ST and GT insertions. The present study
was undertaken to determine which of these tubes had a higher incidence
of otorrhea and then whether silicon tubes stimulated the growth of certain
types of bacteria, such as Staphylococcus aureus. In all, 186 ST and 59 GT
were placed in 245 ears of 144 children. Both ST and GT were separated
into three groups: first insertion of a tympanostomy tube, second implanta-
tion and insertion of a tympanostomy tube in an infected ear in the course
of a mastoidectomy. No differences between ST and GT in causing otorrhea
were found in the three groups. Nevertheless, ST in comparison to GT was
associated with a higher incidence of infections with Pseudomonas aerugi-
nosa. In contrast, a higher incidence of Staphylococcus aureus related to ST
could not be proved. Twenty percent of the ears with mastoiditis were found
to have Pseudomonas aeruginosa, but none of these ears implanted with a
GT developed postoperative otorrhea. Our findings show that GT should be
used when a ventilation tube is used during a mastoidectomy. Further, it is
tenable to implant only GT because postoperative otorrhea in many cases is
caused by insufficient water protection and water is frequently polluted with
Pseudomonas aeruginosa.

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