Instructions for use

Revision: 2.4 (from software version 2.0.16)

Date: 14.09.2022

Your service partner:

 Introduction

Table of contents
1 Introduction .................................................................................................................... 5
1.1 Intended use ........................................................................................................... 6
1.2 Indication................................................................................................................. 6
1.3 Contraindication ...................................................................................................... 6
1.4 Type plates and symbols ......................................................................................... 7
2 Safety instructions .......................................................................................................... 8
2.1 Hazard levels .......................................................................................................... 8
2.2 Safety regulations ................................................................................................... 8
3 Performance of audiometric examinations according to DIN EN ISO 8253-1:2011 ........11
3.1 General notes.........................................................................................................11
3.2 Measurement of the air conduction hearing threshold level ....................................13
3.3 Bone conduction hearing threshold audiometry ......................................................16
3.4 Screening audiometry ............................................................................................18
4 System structure ...........................................................................................................19
4.1 Hardware components ...........................................................................................19
4.2 Driver installation....................................................................................................21
4.3 Software .................................................................................................................21
4.4 Child speech test option .........................................................................................23
5 Patient manager (stand-alone installation).....................................................................24
5.1 Create a new patient ..............................................................................................25
5.2 Changing patient data ............................................................................................25
5.3 Search patients ......................................................................................................25
5.4 Entry / selection of the examiner ............................................................................25
5.5 Starting a new examination ....................................................................................25
5.6 Opening an examination ........................................................................................25
5.7 Deleting an examination .........................................................................................25
5.8 Input / display of findings ........................................................................................25
6 Software reference ........................................................................................................26
6.1 Audiometry - Main Menu ........................................................................................26
6.2 Printout...................................................................................................................32
6.3 Tone audiometry ....................................................................................................34
6.4 Speech audiometry ................................................................................................47
6.5 Options...................................................................................................................51
7 Overview of the symbols, characters and keys used .....................................................55

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Introduction

7.1 Audio audiometry symbols .....................................................................................55

7.2 Symbols Speech Audiometry .................................................................................56
7.3 Key combinations (factory setting)..........................................................................56
8 Cleaning and care instructions ......................................................................................58
8.1 Recommended disinfectants ..................................................................................58
8.2 Recommended surface disinfectants......................................................................58
9 Maintenance and service...............................................................................................59
9.1 Function test ..........................................................................................................59
9.2 Visual inspection ....................................................................................................59
9.3 Electrical safety ......................................................................................................59
9.4 Metrological control ................................................................................................59
10 Troubleshooting .........................................................................................................60
11 Accessories and spare parts list ................................................................................62
11.1 Accessories ............................................................................................................62
11.2 Spare parts ............................................................................................................62
12 GDT connection .........................................................................................................63
12.1 General ..................................................................................................................63
12.2 GDT 6311 ..............................................................................................................64
12.3 PDF Export ............................................................................................................64
13 Hidden features .........................................................................................................65
14 Literature (exemplary) ................................................................................................68
15 Specifications ............................................................................................................69
15.1 Parameter ..............................................................................................................69
15.2 Reference threshold level for the transducers used ................................................70
16 Disposal .....................................................................................................................70
17 Technical data ...........................................................................................................71
18 EMC - Guidelines.......................................................................................................72
19 Declaration of conformity ...........................................................................................76
20 Contact ......................................................................................................................77

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 1 Introduction

1 Introduction
The eAUDIOUSB was designed for daily work in private practice and clinical application. It
impresses with its wide range of functions and intuitive operation. The eAUDIO USB offers you
a comprehensive system for audiological examination with a wide range of tests.
The system offers you the functionality of a complete stand-alone solution. However, it can
also be easily integrated into an administration software.

Use our solutions to make your daily work efficient, uniform and modern. Simply start by
integrating the eAUDIO softwareUSB into the eDiagnosticManager. Benefit from the diverse
possibilities of audiological diagnostics from BioMed. The following options are available to
you:

Product Description
Hand-held device for TEOAE and DPOAE measurements with
special screening mode for neonatal screening.

2-channel PC audiometer with 3 passive loudspeaker outputs for

classic pure-tone and speech audiometry

Fast, PC-supported tympanometer for private practice and clinical

use.

Small, PC-supported measurement module for brainstem

audiometry.

USB-controlled free-field amplifier for lateralisation measurements. 4

inputs can be switched to 6 outputs.

Audiometer keyboard for quick operation of PC audiometers. Can be

conveniently integrated into the eAUDIO softwareUSB.

Page 5
1 Introduction

1.1 Intended use

The eAUDIO is a sound and speech audiometer for diagnostic and clinical use. It can be used
1. In examination rooms of medical practices and clinics
2. By medical professionals or medical auxiliaries who have been instructed in the use
and according to the operating instructions
3. On patients with hearing problems or for routine examination to determine hearing
thresholds.
4. With the accessories listed in the operating instructions

Other uses are only permitted with the consent of BioMed Jena GmbH.
The use of software or hardware of the system with other hardware or software components
not authorised by BioMed Jena GmbH is expressly prohibited.

1.2 Indication
The eAUDIOUSB can be used for the following indications:
➢ for the general examination of hearing
➢ for the determination of pathologies of the auditory organs
➢ for monitoring the progress of curative measures

1.3 Contraindication
There are no contraindications. Side effects are not known or expected. The output of high
intensity levels must be confirmed by the operator and may only be activated if there is a
corresponding hearing loss. Operators must be appropriately trained.

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 1 Introduction

1.4 Type plates and symbols

Nameplate:

20YY.XXX Year of manufacture / Serial no. Number

(Ex. 28-2021.123)

Manufacturer name

Year of manufacture

Type designation

Serial number

Type BF

Protection class II

CENELEC WASTE BIN

Follow the instructions for use!

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2 Safety instructions

2 Safety instructions

2.1 Hazard levels

This is a hazard / denotes a maximum hazard that can lead to serious or fatal
injuries.

This is a warning / indicates a hazardous situation which may result in damage or

! injury.

 This is a note / indicates important information.

2.2 Safety regulations

The "eAUDIOUSB " unit has been designed in accordance with recognised rules and the state
of the art to ensure safe and effective working. Observe the following safety instructions:
Patient safety
• The software and the device are not approved for use in life support or life
sustaining systems or units, or other systems where a malfunction could
reasonably be expected to result in substantial personal injury to the user. The
software is further not released for use as an essential component of any life
support or life sustaining system or units the malfunction of which may cause
the failure of the life support or life sustaining system or unit, or the safety or
effectiveness of which may be affected. Customers using the software in such
applications act at their own risk and must indemnify BioMed Jena GmbH
against all damages resulting from the inappropriate use.

• All serious incidents occurring in connection with the product eAUDIOUSB must
be reported to BioMed Jena GmbH and to the competent authority of the state
in which the user and/or the patient are established!

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 2 Safety instructions

Electrical safety
• The "eAUDIO USB" is designed according to DIN EN 60601 and is assigned
to the following class:
- VDE protection class 2

• The unit may only be operated with the mains voltage listed on the type plate
and only be connected to a properly connected earthed socket.
• The unit is not intended for operation in potentially explosive atmospheres.
• No additional multiple sockets or extension cables may be used.
• The unit has no protection against the harmful ingress of water and other
liquids. If liquids are spilled, check the appliance carefully before use or have
it serviced. Do not use the device if it has visible damage.

• Do not use the unit if the casing is damaged. In this case, arrange for
maintenance of the unit.

• The device is not intended for use in areas where liquids are likely to be present
(e.g. emergency rooms and operating theatres).
• Please do not attempt to open or repair the unit, electric shock may result.
• Opening the housing will void any warranty.
• Use a medically safe PC according to DIN EN 60601-1 to control the device,
provided it is in the patient environment. If a PC according to IEC 62368-1 is
to be used, only the eAUDIOUSB may be in the patient environment. The cables
supplied are long enough to ensure this.
Initial briefing
! • Before using the device, an initial briefing must have been carried out by a
specialist consultant in accordance with the Medical Devices Act MPG /
MPBetreibV Section 1 (Appendix 2), § 7.
Training
! • The functional use of the device and the evaluation of the measurement results
require the necessary specialist knowledge and appropriate training. The
device may therefore only be used by specialist personnel who have been
authorised and instructed in its use by BioMed Jena GmbH or an authorised
dealer (DIN EN 60601-1).
Environmental conditions / Operation, transport, storage
! • The unit may only be used in rooms used for medical purposes.
• Observe the environmental conditions for operation and transport in the
technical data.
• The device must be positioned in such a way that there is good air circulation.
Never cover the unit.
• Do not operate near strong electric or magnetic fields.

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2 Safety instructions

Functional safety
! • Before each use, make sure that the unit is in good working order and carry
out a visual inspection.
• Switch off the unit at the end of practice operation.
Accessories / combination with other devices
! • The unit may only be used with original accessories. Non-original accessories
can cause damage. This will invalidate the warranty.
• Anyone who connects additional devices that are not included in the scope of
delivery or are not authorised by BioMed Jena GmbH is the system
configurator and is responsible for compliance with the relevant standards (EN
60601-1-1)! Such combinations explicitly include connections and connections
via portable multiple sockets.
• BioMed Jena GmbH shall not be liable for personal injury or property damage
if
- no original parts are used,
- safety and application instructions in these instructions for use are
not observed,
- repairs, extensions, assembly and new settings are carried out that
are not authorised by BioMed Jena GmbH or have been carried out
by persons not authorised by BioMed Jena GmbH.
• The declaration of conformity loses its validity in the event of non-compliance
with the intended use, conversion, extension by the customer or by third
parties, as well as the removal of safety and type plates or other manipulations
to the unit.
Maintenance and Service
! • All devices in a practice must be in proper working order and must not pose
any risk to the patient or the operator. The integrity and proper functioning of
a device must be checked regularly by the operator or the practice
representative.
• In addition, a safety and metrological check is recommended regularly after a
period of one year in accordance with chapter 9 of these instructions for use.
Applied Part
! • The headphones (air conduction and bone conduction) are defined as the
applied parts.

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 3 Performance of audiometric examinations according to DIN EN ISO 8253-1:2011

3 Performance of audiometric examinations according to

DIN EN ISO 8253-1:2011

3.1 General notes

The notes and instructions below refer to DIN EN ISO 8253 in the 2011 version.
Hearing threshold levels are determined in audiometry with air and bone conduction.
During air conduction audiometry, the test tone is presented to the subject via special
headphones suitable for pure tone audiometry. During bone conduction audiometry, the test
tone is presented by means of a special bone conduction earphone, which is placed on either
the mastoid or the forehead of the test person. During the hearing threshold determination, the
measurement of the air conduction is started.
For the air and bone conduction measurements, the hearing threshold levels are determined
separately for both ears. For various measurements, the untested (contralateral) ear must be
presented with masking noise via headphones.

3.1.1 Who is allowed to carry out the examination?

The examination may be performed by persons (competent personnel) who have attended
appropriate training on the theory and practice of audiometric examination. This qualification
may be specified by national authorities or other appropriate organisations. The examiner
should be able to make the following decisions during the examination:
a) which ear is tested first (generally the better hearing ear);
b) whether it is necessary to work with masking noise;
c) whether the subject response matches the test signal;
d) whether any interfering noise or behaviour or reactions of the subject invalidate the
test;
e) whether the examination is to be interrupted, whether it is to be terminated or whether
it is to be repeated in whole or in part.

3.1.2 Duration of examination

Care should be taken that the patient does not become unduly fatigued, as it then becomes
increasingly difficult to obtain valid results. It is recommended to allow the patient a recovery
period after an examination duration of approx. 20 minutes.

3.1.3 Environmental conditions for audiometric examinations

In the listening test room, the noise level must not exceed the values in Tab. 1.
Both the patient and the examiner should be seated comfortably during the audiometric
examination and must not be distracted. The climate in the examination room must be within
the permissible range for offices according to local regulations.

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3 Performance of audiometric examinations according to DIN EN ISO 8253-1:2011

Tab. 1 Maximum permissible noise levels according to Article 11, DIN EN ISO 8253-1:2011

Centre Maximum permissible noise level Lmax in dB SPL

frequency of the
Transducer
third octave
band Air conduction Air conduction Bone conduction
HDA 280 DD65v2 B71, B81
in Hz
31,5 56 56 63
40 52 52 56
50 47 47 49
63 42 41 44
80 38 37 39
100 33 31 35
125 28 33,3 28
160 23 27,7 21
200 20 26,7 15
250 19 29,5 13
315 18 32,5 11
400 18 35,4 9
500 18 37,1 8
630 18 37,5 8
800 20 37,2 7
1 000 23 40,4 7
1 250 25 37,8 7
1 600 27 39,7 8
2 000 30 47,6 8
2 500 32 51,5 6
3 150 34 34,4 4
4 000 36 47,8 2
5 000 35 52,7 4
6 300 34 53,7 9
8 000 33 54,6 15
If it is not possible to measure the noise level, a psychoacoustic control of the noise may be
performed. For this purpose, hearing tests are carried out with at least two test persons whose
audiograms are known to be well reproducible and whose hearing threshold levels at all
frequencies are lower than the smallest hearing threshold levels to be determined in the
examination practice. If the hearing threshold levels determined are 5 dB higher or even higher,
this indicates the need for noise reduction in that room. If bone conduction audiometry is
performed in the room, the testing shall be performed with bone conduction audiometry. The

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 3 Performance of audiometric examinations according to DIN EN ISO 8253-1:2011

psychoacoustic control of the noise shall be performed during time of day when audiometry is
usually to be performed.

3.1.4 Instructing the patient at the beginning of an examination

The patient must be familiarised with his or her task before the hearing threshold determination
by presenting a signal with sufficient intensity for a clear response (e.g. pressing the patient's
button, lifting the finger). This familiarisation allows the examiner to make sure that the patient
has understood and mastered the response task.
We recommend the following procedure for instruction:
1. Presenting a sound of 1 000 Hz at a hearing level that is clearly audible, e.g. 40 dB for
a person with normal hearing.
2. Decrease the test tone level in steps of 20 dB until no response is given.
3. Increase the test tone level in steps of 10 dB until a response is given.
4. Present the test tone again at the same level.
If the answers and the sound performance match, the instruction is complete. If not, it should
be repeated. If a second attempt is also unsuccessful, the instruction should be repeated.
In cases of deafness and extreme hearing loss, it may be appropriate to present the
instructions in writing.

3.2 Measurement of the air conduction hearing threshold level

3.2.1 Investigation procedure without masking noise

Two audiometric procedures are described below, the procedures differ only in the sequence
of test tone levels presented.
In the first method, the test tones presented one after the other have increasing levels until a
subject response is given. Then test tones with decreasing levels are presented. In the other
method, the presented signals have increasing levels until a subject response is given. When
performed correctly, both procedures result in essentially the same hearing threshold levels.
The measurements using the first method differ from those using the other method only in the
second of the steps shown below.
If the measurements on one ear at any frequency show a difference in hearing level of both
ears of 40 dB or more, these results should be interpreted with caution due to overhearing.
In this case, the application of masking noise on the contra-lateral ear may be necessary.

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3 Performance of audiometric examinations according to DIN EN ISO 8253-1:2011

Step 1
The first test tone is presented at an audible level 10 dB below the lowest level with subject
response from the instruction at the beginning of the examination. After each presentation of
the test tone without patient response, the level of the test tone is increased in increments of
5 dB until a patient response is given.
Step 2
Method 1:
After the patient response, the level of the test tone is decreased in steps of 10 dB until
there is no more patient response and then a new level increase is started. Continue
this procedure until three responses are made out of a maximum of five level rises at
the same level. If less than three out of five responses are given at the same level in
the rising level procedure, the test tone shall be presented at a level 10 dB above the
last with patient response. The test shall then be repeated.
A shortened procedure with increasing levels gives almost equal results and may be
appropriate in some cases. In this shortened procedure, the test continues until at least
two out of three responses are given at the same level.
Method 2:
After the patient response, the level of the test tone is increased by 5 dB and then a
level decrease is started, decreasing the listening level in steps of no more than 5 dB
until no response is given. The level is then reduced again by 5 dB and the next level
increase is started. This procedure should be repeated until three ascending and
descending series have been passed through each time.
Shortening of this procedure may sometimes be appropriate. In this case, the repeated
level reduction by 5 dB after no response is given is omitted, or, provided that the four
smallest level settings with subject responses do not differ by more than 5 dB, only two
ascending and descending series each are run.
Step 3
The hearing test shall continue with step 2 at the next frequency at an appropriate level setting
based on the previous patient responses. The examination shall be performed for all test
frequencies in one ear.
At each frequency, the instruction can be repeated - also in a shortened form.
Finally, the measurement is repeated at 1 000 Hz. If the results of the repeat measurement at
1 000 Hz match those of the first pass to within 5 dB, the other ear shall be tested. If there is
an improvement or deterioration of 10 dB or more in the hearing threshold level, the hearing
test shall be repeated at further frequencies in the same order until agreement to within 5 dB
or less has been achieved.
Step 4
The examination shall be continued until both ears have been examined.

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 3 Performance of audiometric examinations according to DIN EN ISO 8253-1:2011

3.2.2 Examniation procedure with masking noise

To avoid overhearing of the test tone to the ear not being tested, it is necessary to mask this
ear with a masking noise. In the procedure described below, the masking sound is presented
via headphones.
Although the approach to masking and the choice of masking sound level are largely
determined by experience, the following procedure is recommended for determining the
hearing threshold level with masking.
Step 1
A test tone is presented to the ear under test at a level equal to the threshold level of that ear
when tested without masking. A masking sound shall be presented to the untested ear at an
effective masking level equal to the threshold level of that ear. The level of the masking sound
is increased until either the test tone becomes inaudible or the level of the masking sound is
above the level of the test tone.
Step 2
If the test tone is still heard when the level of the masking sound is equal to that of the test
tone, this is taken as the hearing threshold level. However, if the test tone is masked, its level
is increased until it is heard again.
Step 3
The level of the masking sound is increased by 5 dB. If the test tone is not heard, increase its
level until it becomes audible again. Repeat this until the test tone is still heard even though
the level of the masking sound has been increased by more than 10 dB.
The correct level of masking sound is achieved when the test tone can still be heard without a
level increase. The procedure should have resulted in a correct determination of the hearing
threshold level at this test frequency. The correct masking level is noted.

This method searches for a plateau. However, if the plateau is very shallow, this
procedure may also give false results. The masking sound may also mask the test
 tone in the ear being tested. This masking can be reduced by presenting the
masking sound with an in-ear headphone.

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3 Performance of audiometric examinations according to DIN EN ISO 8253-1:2011

3.2.3 Calculation of the hearing threshold level

The hearing threshold level for each ear and frequency must be determined as follows,
depending on which measurement method was used.
Method 1
For each test frequency and ear, the lowest level at which subject responses are given in at
least half of the level rises shall be determined. This level is defined as the hearing threshold
level. If the spread of the smallest levels with patient response is more than 10 dB at any
frequency, the test should be considered unreliable and repeated.
Method 2
For each ear, at each frequency, the smallest levels at which patient responses are given at
level increases are averaged. Similarly, for each ear and at each frequency, the smallest levels
at which patient responses are given at level decreases are averaged. The mean value is
calculated from the two values determined in this way for each frequency and for each ear.
This average is rounded to the nearest dB and taken as the hearing threshold level for that
frequency and ear. If the lowest levels with patient responses differ by more than 10 dB for
level increases and/or if the lowest levels with patient responses differ by more than 10 dB for
level decreases, the test should be repeated.

3.3 Bone conduction hearing threshold audiometry

The determined hearing threshold levels for air conduction depend to a certain extent on the
audiometric test procedure. This aspect has not yet been systematically investigated for bone
conduction audiometry. Therefore, no correction values for different techniques (manual or
automatic recording) are currently recommended for bone conduction audiometry. The same
measurement procedures should be used for air and bone conduction audiometry.
For accurate monaural hearing threshold determination, bone conduction audiometry requires
masking of the signal in the untested ear regardless of level. Where precise monaural bone
conduction hearing threshold is not required, bone conduction audiometry can be performed
without masking. Some bone conduction audiometers have a distinct airborne component
above 2000 Hz. The influence of this component can be minimised by applying earplugs.
However, it must be considered that the possibility of ear occlusion effect is also present at
frequencies above 2 000 Hz.
When the bone transducer is placed on the mastoid, the sensation threshold is reached at
hearing levels of about 40 dB at 250 Hz, 60 dB at 500 Hz and 70 dB at 1 000 Hz. However,
large individual differences may occur. Therefore, care must be taken not to misinterpret
vibrotactile sensations as auditory perception.

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 3 Performance of audiometric examinations according to DIN EN ISO 8253-1:2011

3.3.1 Method for hearing testing with masking in bone conduction audiometry
Although the approach to masking and the choice of masking sound level will be largely
determined by experience, the following procedure for determining the hearing threshold level
with masking is recommended.
Step 1
After placing the bone transducer, the masking sound headphone is placed on the ear that is
not to be tested. Care must be taken to ensure that the headpieces of the two sound emitters
do not interfere with each other. First, the hearing threshold level without masking is
determined. This measurement may not give the actual bone conduction hearing threshold
without occlusion because the ear occlusion effect on the non-tested ear may influence the
measurement result.
Step 2
The test tone is presented again at the same level, but at the same time a masking sound is
presented to the untested ear at an effective masking level equal to the air conduction
threshold level of the untested ear. Now the level of the masking sound is increased until the
test tone is no longer heard or until this level is 40 dB above the level of the test tone.
Step 3
If the test tone is still heard when the level of the masking sound is 40 dB above that of the test
tone, the level of the test tone is taken as the hearing threshold level. If the test tone is masked,
its level shall be increased until it is heard again.
Step 4
The level of the masking sound is increased by 5 dB. If the test tone is no longer heard, its
level is increased until it is heard again. Repeat this procedure until the test tone remains
audible even though the masking sound level has been increased by more than 10 dB. This
level of masking sound, where no increase in the test tone level was required for its
perceptibility, is the correct level of masking sound and the procedure should have yielded the
true audible threshold level at the test frequency. The correct masking level shall be noted.

This method searches for a plateau. However, if the plateau is very shallow, this
procedure may also give false results. The masking sound may also mask the test
 tone in the ear being tested. This masking can be reduced by presenting the
masking sound with an in-ear earpiece.
The plateau can have a slope greater than zero due to central occlusion.

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3 Performance of audiometric examinations according to DIN EN ISO 8253-1:2011

3.4 Screening audiometry

In screening audiometry, the test tones at the screening level are either audible or inaudible to
the subject. This test shows whether the hearing threshold levels are higher than or equal to
or lower than the screening level.
Screening audiometry can be combined with hearing threshold measurements at the
frequencies where the patient has failed the screening test.

3.4.1 Carrying out the screening test

The test consists of the presentation of one or more test tones at specified frequencies and
levels and a recording of patient responses.
The test tones are presented with increasing frequency, starting at 1 000 Hz, followed by the
frequencies below 1 000 Hz with decreasing frequency.
First, a test tone at 1 000 Hz with a hearing level of 40 dB is presented to the patient's right
ear to check whether the patient has understood the instructions. If not, the instruction is
repeated and the test tone is presented again. If the subject again does not respond, the level
shall be increased until a subject response is given.
Then the level of the test tone is adjusted to the required screening level and the test tone is
presented twice with a duration of 1 to 2 s each with a pause of 3 to 5 s. If both signals are
heard, the subject has passed the screening test at that frequency. If only one signal was
heard, a third signal is presented. If this third signal is heard, the subject has passed the
screening test; if not, or if the first two signals were not heard either, the subject has failed the
screening test at 1 000 Hz at the set screening level. The test is then continued with the other
designated test frequencies and subsequently the left ear is also tested accordingly.

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 4 System structure

4 System structure

4.1 Hardware components

4.1.1 Scope of delivery

➢ eAUDIOUSB
➢ Air conduction coupler (DD65v2 / HDA300)
➢ Bone conduction coupler (B-71 / B-81)
➢ Patient push-button
➢ Patient microphone
➢ Examiner headset
➢ Power supply unit SMDA51-T03
➢ Mains cable
➢ USB cable
➢ Instructions for use

4.1.2 Commissioning
The unit can be operated as a desktop unit on a table, but also mounted on the wall. It must
be ensured that the lines of the handset and the patient push-button can move freely. The
respective connections are marked in colour on the housing.

! Only the couplers included in the scope of delivery may be connected!

Please note that when using the free-field functions via external speakers, these
! must be calibrated on site!

4.1.3 Connections

Fig. 1 Back of device

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4 System structure

Fig. 2 Device connections (top view)

Connection Connection Notes

Patient push-button 3.5 mm jack plug
(N)
USB 2.0 connection Only use USB 2.0 certified cables
(M)
Power supply unit Only the original power supply unit
(L) SMDA51T03-
Air conduction - right Sennheiser HDA 300/ DD65v2, red plug
(K) 6.5 mm jack
Air conduction - left Sennheiser HDA 300 / DD65v2, blue plug
(J) 6.5 mm jack
Bone conduction Radioear B- 71/ B-81,
(I) green plug, 6.5 mm jack
Patient microphone Electret microphone for patient response
(H)
Examiner microphone Electret microphone for addressing patients
(G) (3.5 mm jack) pink plug→ on headset
Examiner listener Headphones for listening to the test signal
(F) (3.5 mm jack) →green plug on the headset.
Line in Stereo line-in for connecting an external CD
(E) player (3.5 mm jack)
Line out Stereo line-out for connecting active speakers
(D) (3.5 mm jack)
Free-field Connection for a passive loudspeaker type
(C) loudspeaker right Behringer 1C with 4 Ohm impedance
Free-field Connection for a passive loudspeaker type
(B) loudspeaker central Behringer 1C with 4 Ohm impedance
Free-field Connection for a passive loudspeaker type
(A) loudspeaker left Behringer 1C with 4 Ohm impedance

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 4 System structure

4.2 Driver installation

The eAUDIO connects as an USB-HID device and therefore uses standard drivers. A manual
installation of drivers is not necessary.

4.3 Software
The eAUDIO USB installation package is included in the scope of delivery.
System requirements:
Category Minimum requirements Recommended
Processor Intel core i5 Intel core i5
Storage space 2 GB 2 GB
Working 1024 MB 4 GB
memory
Display 1280x1024 FullHD (1920x1080)
Operating Windows 7 Windows 10
system
USB 1 x USB 2.0 1 x USB 2.0

4.3.1 Installation
Connect the eAUDIOUSB to an USB port and switch it on.
The installation is located on the USB stick supplied. For an installation together with the
eDiagnosticManager, start it via the "Start" link.
For a standalone installation, start the file "setup.exe" in the folder "BioMed Software
Suite\eAUDIO v2".
Follow the instructions of the installation wizard. Restart the computer after the installation. All
necessary drivers are set up during the installation. The settings of the programme can be
stored in the folder "My Documents\BioMed Jena\eAUDIO". Alternatively, you can use the
public documents folder:
C:\Users\Public\Documents\BioMed Jena\eAUDIO

Should the installation be carried out as an administrator, the folder with the
 settings must be copied from this account to the user account. In any case, avoid
using multiple settings folders.

4.3.2 Verification of the configuration

To complete the hardware and software installation, carry out a function test. To do this, open
the eAUDIOUSB software. Check whether sounds can be played via the headphones. If the
programme does not issue an error message when you start it, the installation is complete and
you can use the programme. If, contrary to expectations, errors should occur, please read the
chapter 10 "Troubleshooting".

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4.3.3 Setting up the data management

Tip: Use the supplied eDiagnosticManager for configuration.
The eAUDIOUSB software offers you all the possibilities of perfect integration into your practice
organisation. The programme can be called up via the eDiagnosticManager.
To make a manual adjustment to the configuration, press the "O" key or click with the right
mouse button in the white field at the top right. The "Options" button appears. This is clicked
with the left mouse button and the options window appears. The following input mask appears:

Fig. 3 Options, system settings

There you can enter the paths to the database and for the GDT connection. Furthermore, the
address can be stored here, as it should also appear on the printouts. It is possible to enter
network paths.

Please remember to set up a backup strategy for the database, as this is not part
! of the software scope.

4.3.4 App selection

In the item "Apps" you can select which applications are to be displayed to you. The eAUDIOUSB
software can integrate the devices eAUDIOUSB, eTYMPUSB and eABRUSB. You can select or
deselect the individual apps here.

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4.3.5 Change language

The eAUDIOUSB offers the possibility to select from different languages. The installed
languages are displayed in the selection box. Select the desired language and save the setting.
Tip: Use the eDiagnosticManager to select languages.

4.3.6 Update
You can download and install the latest version of the software by clicking on the "Update"
button. The download and installation start automatically.
After a successful update, the software is restarted and a file with the new features is displayed.
You can display this file again at any time by clicking on the "ChangeLog" button.

4.3.7 Display mode

Select this item to use the programme as a viewing place.

4.4 Child speech test option

A second monitor with touch screen function and FullHD resolution (1920x1080) is necessary
for an audiometer with the option "child speech test".
After successful installation of the eAUDIO software, the image data for paediatric audiometry
must be copied from the installation medium. Select the documents folder of the eAUDIO
software as the destination, e.-g. C:\Users\USER\Documents\BioMed Jena\eAUDIO.
If you have any questions about installation, please contact your specialist dealer.

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5 Patient manager (stand-alone installation)

5 Patient manager (stand-alone installation)

If you use the unit without the eDiagnosticManager, the patient manager opens after the
programme starts. There you can create, edit or delete patients if you do not use the software
in connection with a practice administration software. For the use of the GDT interface see
section "GDT connection". You can also open the patient manager by clicking on the button
or pressing the "P" key.

Fig. 1 Patient manager

Explanation of the individual functions:

Button Function

Create a new patient.

Delete a patient.

Delete the currently selected measurement.

Saving the data.

Cancel Patient Manager.

Open the selected measurement.

Start a new measurement.

Display and input of findings

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5.1 Create a new patient

With a click on you can create new patients. You can now enter the patient's data. Save

the data by clicking on .

 The entries surname, first name and date of birth are mandatory.

5.2 Changing patient data

To change patient data, simply enter the new data. Confirm the changes by clicking on .

5.3 Search patients

You can search the patient list by name or patient number. To do so, use the search field below
the patient list.

5.4 Entry / selection of the examiner

To create a new user, type their name in the field below the measurement list. Then click on
to accept the name. Press to delete entries.

5.5 Starting a new examination

To start a new measurement for the selected patient, click on .

5.6 Opening an examination

To open a new measurement, select it in the measurement list and click on . Alternatively,
you can open the measurement directly by double-clicking on the list entry.

5.7 Deleting an examination

To delete a measurement from the database, select the desired measurement and click on
.

5.8 Input / display of findings

In the patient manager you have the option of storing findings for the currently selected patient.
Click on to open the findings mask. For further explanations see 6.1.8.

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6 Software reference
The eAUDIO USB offers you a comprehensive package of functions for your daily work in
practice. It is designed in such a way that it can be expanded at any time to implement new
functions or to incorporate new findings.

6.1 Audiometry - Main Menu

After calling up a new measurement, the programme starts in pure tone audiometry.

Fig. 4 Audiometry main window


If the mouse pointer remains on a button for a moment, a note about its function is
displayed.

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6.1.1 Toolbar
The most important functions can be called up quickly via the toolbar.

Button Function

Patient manager: /or "P" key

Opens the patient database

Record new measurement: /or "M" button

Removes all data and clears the charts

Save measurement: /or "S" button

If a new measurement is taken, it is saved immediately, otherwise the
system asks for an overwrite.

Show / hide measurement: /or "E" key

Shows or hides the selected measurement. Possible during loading and
new measurement.

Print: /or "D" key

Opens the print dialogue

Audiometer initialised and working correctly.

Audiometer not initialised (click for initialisation)

Display of all measurements (in sound audiometry)

Insertion of the sound audiograms (in speech audiometry)

Create / display findings on the patient

6.1.2 Audio keyboard AudioControl

Fig. 5 Key assignment AudioControl

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6.1.3 Audiometer control

Button Function

Air conduction /or "F5" key

Bone conduction /or "F6" button

Free field /or "F7" key

Masking noise /or "F8" key

Examiner microphone / or "F4" button

Opens the microphone channel to address the patient

Listening button / patient microphone:

For listening to the examiner for sound and speech as well as for the
response via the patient microphone

6.1.4 Markings / Safety threshold

Button Function

Unsafe measurement /or "C" key

Patient gives very different hearing thresholds

No measured value /or "X" key

Patient does not hear this frequency

Safety threshold limited /or "F" key

Patient protection against excessive volume (value can be set in
options)

Delete measuring point

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6.1.5 Tone Preselection / Suprathreshold Tests

Button Function

Pulse tone /or "1" button

Wobble tone /or "2" button

Continuous tone: /or "3" button

When the button is activated, the function of the sound key is reversed

Discomfort threshold /or "4" button

SISI test: /or "5" key

Test is carried out in a separate window.

Stenger test /or "6" key

Langenbeck test /or "7" key

Fowler- Test /or "8" key

Lüscher test
Test is carried out in a separate window

Recommended tests: /or "9" key

Indicates recommended tests resulting from the examinations.

"Degree of disability"
Represents the degree of disability based on the data displayed.

"Tinnitus"
Opens the dialogue window for automatic determination of the tinnitus
tone and volume.

"Tinnitus Masking"

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6.1.6 Speech audiometry controls

Button Function

Play selected title

(Play)

Break

Cancel playback
(Stop)

Discomfort threshold

Hearing aid

Delete measuring point

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6.1.7 Measurements / patient data

Fig. 6 Information on measurements / patient data in the header

All measurements performed on the current patient are listed in the list field. A measurement
can be selected by clicking on it; it can also be faded into a current measurement. Double-click
to load the measurement.

If the mouse cursor remains on an entry in the list, a note is shown, containing
 information about the stored measurement (tone or speech audiogram or both).

Fig. 7 Display of the current and the superimposed measurement

In "Current measurement" the date, time and sequence number of the current measurement
are displayed.
In "Overlayed", the date, time and sequence number of the superimposed measurement
selected from the list on the left are displayed.
The patient data (name, first name and patient number and age) and the current examiner are
displayed on the right in the data field.

6.1.8 Findings / Comments

The button opens a window for creating / displaying and editing findings for the current
patient.

 A green bar under the button indicates existing entries.

Fig. 8 Findings window

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6.2 Printout

6.2.1 General
The eAUDIOUSB allows you to conveniently create reports. A special report is available for each
test. In principle, the diagrams currently displayed (including the measurements shown) are
also used for the report.

With the key combination "CTRL "+"P" it is possible to print reports directly. The
 last used printer and the last used report configuration are used for this purpose.

Clicking the "Print" button or pressing the "D" key opens the print menu.

Fig. 9 Print menu

6.2.2 Printer selection

In the left-hand field you can select the desired printer. The default printer of the operating

system is set as the preferred printer in the software. You can use the field to set the
number of copies you want.

6.2.3 Report selection

In the field below, you can choose from various report configurations:

Fig. 10 Selecting the print configuration

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6.2.4 Example printout

In the options dialog (chapter 6.5.3), you have the possibility to change the layout of the speech
audiogram printouts. You can choose between the separated (vertical) layout and the
combined (horizontal) layout of the speech audiogram. Additionally, there is the option to add
a legend of the colours and symbols in use.

Fig. 11 Separated printout speech audiometry

Fig. 12 Combined printout speech audiometry

6.2.5 PDF generator

You have the option of having PDFs automatically generated and saved to a specified location
when saving. To configure this option, please contact your service provider.

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6.3 Tone audiometry

The execution of air and bone conduction threshold audiometry is documented in DIN EN ISO
8253-1:2011-04. The programme for pure tone audiometry follows this standard. After creating
a new examination, the programme automatically starts with the interface for tone audiometry.

You have the option of starting the patient address via the button (F4 key).
 Especially when using listening booths, the examiner can give instructions to the
patient in this way. The volume of the speech can be adjusted via the green bar.

6.3.1 Air conduction in the standard range (125-8000 Hz)

The patient puts on the headphones, red - right and blue - left.
After starting a new measurement, the AC coupler is automatically selected. The sound setting
starts at the frequency 1 kHz and the volume 0 dB HL.
Sound output
The tone is set by means of the "space bar". By pressing the "3" key or clicking on the button
, the tone preset can be switched as a transmitter or as a breaker via the "space bar". The
selected position is saved and is automatically preselected for the next measurement.
Level changes
The level (volume) is changed by pressing the vertical arrow keys (↑/↓). The tone is set via the
"space bar". When the patient recognises the tone (presses the patient button), a visual signal
appears (measuring field outline).

You can also make level changes comfortably with the mouse. Use the mouse
 wheel or click with the left mouse button in the diagram.

Confirmation
The hearing threshold is confirmed by pressing the "Y" key or the Enter button. The marker is
placed in the diagram field and entered as a numerical value in the table below.
Corrections are possible by pressing the "Y" key or Enter button again.
Frequency changes:
The frequency is changed using the horizontal arrow keys (←/→). When changing the
frequency, the volume level is automatically reduced by 30 dB (level change adjustable in the
options). After reaching 8 kHz or 125 Hz, the frequency automatically jumps back to 1 kHz at
the next keystroke.

With the option "Fast Select" (section 6.5.3) you can select frequency and level
 comfortably with the mouse. A crosshair for the preselection is displayed. Confirm
the selection by clicking with the left mouse button.

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Change side
The pages are changed by pressing the "R" and "L" keys or by clicking with the mouse pointer
in the audiogram concerned.

Uncertain answer
If the patient's answer is uncertain (indicates different hearing thresholds at the same
frequency), this button or button "C" places a question mark in the audiogram.

No measured value
If the patient does not recognise any sound at a frequency, click this button or press the "X"
key. An arrow pointing downwards appears at the lower edge of the diagram for this frequency.

Safety threshold (patient protection)

To avoid injuries caused by tones that are accidentally set too high, the direct tone setting is
limited to volumes up to 90dB (changeable in options). When the limits are reached, the sound
switches off and the crosshairs (frequency and volume) change colour to black.
To reach higher volumes, this button must be clicked or the "F" key pressed.

6.3.2 Bone conduction

The bone conductor is selected by pressing the "F6" key or by clicking on the "Bone conductor"
button. The bone conductor is placed on the corresponding mastoid. The tone and frequency
settings correspond to those of the air conduction, they are only reduced in volume and
frequency.

6.3.3 Masking

 The accepted rules for proper masking of the contralateral ear shall be observed.

The masking is selected with the key "F8" or by clicking this button. The masking level is shown
as an orange line on the opposite side and as a numerical value in the data field between the
two diagrams under "Masking".

You also have the option of displaying the selected frequency on the masking side.
To activate this function, see “13 Hidden features”.

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The type of masking can be set in the options:

- Manual masking
- Floating masking.
Manual masking
The manual masking level can be adjusted manually using the "Picture up" and "Picture down"
buttons.
Floating masking
The masking level follows the level of the test tone with a difference of 30 dB (adjustable in the
options). During the measurement, the difference can be changed by pressing the "Page up"
and "Page down" keys. This new difference is maintained until the end of the current
measurement and is only reset when the side is changed.
Confirmation
When the hearing threshold is confirmed by pressing the "Y" key, the masking is also confirmed
and entered in the diagram.
Masking with bone conduction
The masking works in the same way as with air conduction. The headphones are placed
diagonally on the contralateral ear. When changing sides, the bone conductor and headphones
must be moved.

Please observe the accepted rules of masking! At frequencies above 2000 Hz,
 overhearing on the air line can be avoided by using an ear plug.

6.3.4 Sound audiometry in the extended high frequency range (9000-16000Hz)

The frequencies in the extended frequency range can be accessed via the "High Frequency"
tab.

Fig. 13 Interface of the high tone audiometry

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The measurement of the frequencies in the extended high-frequency range is analogous to

the measurement in the classic audiogram. Please note that not every headphone is suitable
for all frequencies. If you have any questions, please contact your specialist dealer.

6.3.5 Display of all measurements

Fig. 14 Window: All measurements

If you are in sound audiometry, you can click on the eye to open a new window in which all
measurements available for the current patient can be displayed superimposed. In the upper
field you can choose which examination you want to display (air conduction, bone conduction,
etc.). In the middle field you can select or deselect individual measurements and adjust their
appearance (colour, line thickness, type).

By clicking on the button you can print out the current diagrams.

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6.3.6 Suprathreshold and supplementary tests

6.3.6.1 Discomfort threshold

The discomfort threshold is selected by pressing the key "4" or by clicking on the button
"discomfort threshold". The tone and frequency setting is the same as for the air conduction.
The space bar is automatically switched as a tone "transmitter" button with continuous tone. If
the discomfort threshold is found, it is marked with "Y" and entered in the diagram.

6.3.6.2 Weber test

A tuning fork (440 Hz) is struck and placed on the top of the patient's head or forehead. With
normal hearing, the patient should perceive the tone as being in the middle. The right or left
Weber field is clicked with the mouse pointer and the arrow pointing to the opposite side is
marked. In the case of non-central perception, for example, the right field is clicked and the
arrow pointing outwards is marked.

Fig. 15 Entries for Weber Test

6.3.6.3 Rinne test

A tuning fork (440Hz) is struck and held close to the patient's ear and then placed on the
mastoid. If the patient feels the air conduction louder than the bone conduction, the Rinne-
evaluation is positive (+). To do this, click on the "Rinne" field and mark "+" (plus). If the bone
conduction is perceived as louder, "-" (minus) is marked.

Fig. 16 Entries for Rinne test

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6.3.6.4 SISI test

The SISI test (Short Increment Sensitivity Index) is an audiometric method used in ENT medicine to
examine the detectability of small fluctuations in volume. Since the volume fluctuations are offered above
the hearing threshold, the SISI test counts as suprathreshold audiometry. The test allows conclusions to
be drawn about the presence of a recruitment and thus about the location of the damage in sensorineural
hearing loss. Like the Lüscher test, the test is based on the increased detectability of small intensity
fluctuations in cochlear sensorineural hearing loss (in relation to the hearing threshold) compared to normal
hearing. Compared to the Lüscher test, the test represents a methodological simplification that makes the
testing process much easier for both the person being tested and the examiner. The test was developed
by James Jerger and colleagues in 1959.

[Wikipedia]

Fig. 17 Control panel for SISI test

The SISI test is performed at 20 dB above the air hearing threshold. For this purpose, the
frequency/volume cross in the sound audiogram is set to this volume and the corresponding
frequency.
Then open the SISI test via the corresponding button. The side, frequency and volume from
the tone diagram are displayed in the SISI test window. The values for side, frequency and
volume can also be set or changed manually in the SISI test window.
Conditioning:
To condition the patient, first let him practise recognition with 5 dB, then with 3dB. To do this,
click on the button "Start test". The volume of the increments can be selected in the increment
window with 1, 3 and 5. When the patient recognises the increase in volume, he/she should
press the patient button. An optical signal appears as an indication. The correct answers (which
lie within the time window) are automatically counted and displayed as a percentage. If, for
example, 4 increments were given and recognised, 100% is displayed. This display method
allows the test to be ended prematurely in the case of reliable recognition.

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Examination procedure:
The actual SISI test is performed with increments of 1 dB increase. So that the patient does
not get used to the regularity of the level jumps, the test procedure should be interrupted a few
times by clicking on the "Pause" button. The course of the measurement with 20 increments is
displayed by means of a green bar.
The result of the SISI test is transferred to the audiogram and the numerical table by clicking
on the button "Accept value". You can stop the test at any time by clicking on the "Cancel test"
button. The test is ended by clicking on the "X" button at the top right of the SISI window.

6.3.6.5 Stenger test

The Stenger test is an audiometric method used in otorhinolaryngology to detect the simulation of unilateral
deafness or hearing loss. The test is based on the phenomenon that a sound offered on both sides but
with different volumes is only perceived on the side of the louder sound.

The test was described by Paul Stenger in 1900:

"If a tuning fork of the same pitch is held in front of each ear, it will only be heard on both sides if it is struck
at the same time, at the same distance and with normal hearing ability on both sides. But even a minimal
change on one side, which can be either a slight shift in distance or a stronger attack, is enough to cause
the pitch to swing immediately in favour of one side. [...] In a man with doubtful left-sided deafness, if the
ears are not closed, first bring one [...] tuning fork from the right to the right ear until the person examined
states that he can hear the tuning fork. [...] If a tuning fork of the same pitch is now held close to the
allegedly deaf left ear [...] and a tuning fork struck at the same time is now approached from the right, this
will be heard [...] if the left ear is really deaf. If the left ear is not deaf, but still has the ability to hear, the
tuning fork approached from the right will not be heard on the right until the tuning fork held in front of the
left ear, i.e. the ability to hear of the left ear, is switched off".

Later, the test was hardly ever described with such clarity.

The test is carried out today using a sound audiometer. A tone 10 dB above the hearing threshold is offered
via headphones to the "good" ear. The same tone is then offered to the questionably deaf ear in increasing
intensity. If this ear is actually deaf, the person being tested will state that he or she continues to hear the
tone in the good ear. If, however, the deafness is simulated, the person being examined will state that he
or she no longer hears the tone in the good ear after a certain volume of the tone in the allegedly deaf ear,
because he or she now hears the tone in the allegedly worse ear louder. By repeated measurement, the
actual hearing threshold of the allegedly deaf ear can be determined in approximation.

The interpretation of the Stenger test is not easy, so the test should only be performed by experienced
examiners.

[Wikipedia]

Examination procedure:
The Stenger test is activated with the "6" key or by clicking the button. The mouse pointer is
used to click in the audiogram of the ear to be tested or the side is selected using the "R" and
"L" keys. The frequency can be changed on both sides with the horizontal arrow keys (←/→).
The volume of the test tone can be adjusted in the test ear with the vertical arrow keys (↓/↑)
and in the opposite ear with the "Page down" "Page up" keys. The marker is set in the diagram
of the test ear with "Y".

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6.3.6.6 Langenbeck test

Noise audiometry according to Langenbeck is an audiometric method used in ENT medicine
to determine the hearing threshold for sounds in a masking noise. The test allows conclusions
to be drawn about the location of the damage in the case of sensorineural hearing loss. The
examination method was presented by Bernhard Langenbeck in several publications in 1949
and 1950 and was also later scientifically processed.
Examination procedure:
The Langenbeck test is activated with the "7" key or by clicking the button. On the page to be
tested, the level of the noise appears in orange and can be changed using the "Page up" and
"Page down" keys. On the same page, the level of the test tone is shown in green or red and
can be adjusted with the horizontal arrow keys (←/→).
The marker is set with "Y" in the diagram of the test tube.

6.3.6.7 Fowler test

The Fowler test (ABLB test, Alternate Binaural Loudness Balance Test) is an audiometric method used in
ENT medicine to compare the loudness perception of the hearing of both ears. The Fowler test can only
be used in cases of unilateral or significantly side-differentiated hearing loss. The test allows conclusions
to be drawn about the presence of a recruitment and thus about the location of the damage in the case of
sensorineural hearing loss. It is interesting to note that originally the detection of a recruitment was used
as a differential diagnostic tool to distinguish a sensorineural hearing loss from a conductive hearing loss,
i.e. a recruitment was considered a characteristic of any sensorineural hearing loss. The test was published
by Edmund P. Fowler in 1937.

[Wikipedia]

Examination procedure:
The Fowler test is activated with the key "8" or by clicking on the button. When the test is
carried out, a tone is automatically offered alternately to both ears at different volume levels.
The level is now adjusted according to the test person's specifications so that the test person
has the same impression of loudness in both ears, i.e. in the ear with normal hearing and the
ear with hearing loss. This procedure is carried out several times, starting from different volume
levels. The test procedure was not explained expressis verbis by Fowler, later it was suggested
to first offer a tone 20 dB above the hearing threshold of the worse ear and to level the
corresponding loudness in the healthy ear. The result is recorded on the tone audiogram form.
This process is now repeated in 20 dB steps, so the next sound offered is 40 dB above the
hearing threshold, and so on. With "R" and "L" or by clicking with the mouse, the side with the
greater hearing loss is selected. The volume and frequency settings are made on this page
with the arrow keys.
The level setting on the opposite side (without selecting the side again) is then made with the
"Page up" "Page down" keys until the patient has the same volume perception. The markers
are set with "Y".

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6.3.6.8 Lüscher test

The Lüscher test is an audiometric method used in ear, nose and throat medicine to examine the
detectability of small fluctuations in volume. The test allows conclusions to be drawn about the presence
of a recruitment and thus about the location of the damage in the case of sensorineural hearing loss. The
test was developed by Erhard Lüscher and Josef Zwislocki in Basel and described in 1948. The test was
later modified and simplified and became widely used in the form of the SISI test.

[Wikipedia]

Fig. 18 Operating window of the Lüscher test

Examination procedure:
The Lüscher test is activated by clicking the button. During the test, a tone with pulsating
intensity is presented. Two intensity changes are offered per second, so the tone fluctuates in
volume at this rhythm.
The base level of intensity can be set manually, in the default setting it is 20 dB above the
corresponding hearing threshold. The lowest detectable volume fluctuation is sought. The
pulsating tone is presented for a duration that can be set in the configuration file (default value:
10s). The patient is asked to press the button once when he hears a difference in volume.
Alternatively, the examiner can press the button "Patient response" if the patient has otherwise
signalled that he/she has registered the fluctuation. The following increments are available: 5
dB, 4 dB, 3 dB, 2 dB, 1.5 dB, 1.2 dB, 1 dB, 0.8 dB, 0.6 dB, 0.4 dB, 0.2 dB, 0.1 dB.
The test is started via the button "Start test" and ends either after a patient response, by
pressing the button "Cancel test" or after a configurable time (default value: 10s).
There are 3 procedures available for this purpose:
➢ Manual:
The examiner sets all parameters (frequency, base level and intensity variation)
manually. Only one run of the examination is performed with these parameters. If the
level fluctuation is detected, the corresponding increment is entered in the table.

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➢ Single frequency:
The examiner sets the parameters frequency and base level manually. The
measurement starts with an increment of 5dB. If this is detected, the measurement is
repeated with a reduced increment. This continues until the intensity fluctuation is no
longer detected.
➢ Automatic:
The measurement takes place at all frequencies stored in the configuration file. At each
frequency, a single frequency measurement is made with descending increments until
no more response is given. Then the next frequency is selected and the measurement
is carried out. The buttons and can be used to jump back to the last frequency
or forward to the next frequency.
Closing the window or pressing ESC ends the test and accepts the results.

6.3.6.9 Recommended tests

These notes on recommended tests should be taken as indications only. The test
 recommendations are based on the following literature:
Audiometrie – Eine Anleitung für die praktische Hörprüfung [1]

Test Criteria
Stenger Difference of 40 dB between the hearing thresholds of the right and left
side over the entire frequency range
SISI Hearing loss in air conduction of >40 dB at one frequency (frequencies
are displayed)
Langenbeck High frequency drop or high frequency sink
Fowler Difference of 30 dB between the hearing thresholds of the right and left
side at selected frequencies
Lüscher Bone conduction hearing threshold more than 40 dB above the air
conduction hearing threshold of the respective side

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6.3.6.10 Tinnitus determination

This automatic test is performed by the patient alone. Starting from a start frequency to a final
frequency, the presented tone/noise is changed. The patient confirms with the patient button
when the sound is most similar to his/her tinnitus. The patient can also influence the
presentation with the patient button. After a successful search, the value is transferred to the
audiogram.
Conditioning:
Explain to the patient that they can control the presentation of the sound by pressing the patient
button.
After starting the measurement, the tone is changed either linearly or logarithmically starting
from the start frequency to the end frequency. He should press the patient button briefly when
he recognises the tinnitus frequency. The tone then remains constant.
The patient can restart the change by another short actuation or reverse it by a longer actuation
(frequency of the sound decreases).
Examination procedure:
Start the examination at a volume of approx. 20 dB above the hearing threshold. After the
patient has successfully found the sound, it is transferred to the audiogram with the button
"Insert".

Fig. 19 Operating window for tinnitus determination

6.3.6.11 Tinnitus masking

If this function is selected, you can present a narrowband noise at the selected frequency on
the selected ear. If the patient's tinnitus can be masked with this, accept the value with the "Y"
key.
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6.3.6.12 Determination of the degree of disability

Fig. 20 Display window of the calculated degree of disability

You can use this function to calculate the percentage hearing loss. Various tables with different
weightings are available for this purpose. These are based on the Königsteiner Empfehlung
(Update 2020) as well as the Swiss guidelines for ORL expert doctors.
The tables can also be used to assess / evaluate the degree of disability caused by the hearing
loss. The resulting assessment can be adjusted by the expert, as intermediate values are
possible and factors such as age at onset of the impairment play a role. Reasons for the
adjustment can be noted in the comment field. By clicking on the print button, the tables with
the assessments can be printed out.

Please note that appraisal work requires continuous training and this part of the
! programme is only intended to provide an initial overview.

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6 Software reference

6.3.7 Option: Second air conduction coupler

Optionally, you have the possibility to use a clinical version of the eAUDIOUSB. This has a
second connection for an air conduction headphone (left and right; 6.3mm mono jack). This
option is suitable for the use of InEar headphones.

Use only calibrated headphones. If you are interested in the clinical version, please
! contact your specialist dealer.

Configuration:
In the clinical version, you have the option of assigning the various stored air conduction
receivers to the two connections. This is done in the options:

Fig. 21 Setting of the couplers used in the clinical version

Under "AC 1" or "AC 2" you can select from the stored couplers. The sketch shows which entry
is switched to which connection.
Application:
If the software detects a clinical version, an additional button appears in the control bar next to
the normal air conduction handset to select the second air conduction handset as an output.

The audiometry is then carried out as usual.

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 6 Software reference

6.4 Speech audiometry

Speech audiometry is accessed by switching to the "Speech audiometry" tab (above the
audiograms on the left).

Fig. 22 Speech audiometry user interface

With the keys "R" and "L" or by clicking on the diagram fields, the side to be examined is
selected. The transducer (air conduction, free field) is determined with the keys "F5" and "F7"
or the corresponding buttons. The volume of the speech signal is adjusted with the vertical
arrow keys (/). Alternatively, you can change the volume with the mouse wheel.
The masking is activated with "F8" or the button if required, the volume is adjusted with the
buttons "Page up” and "Page down". The available speech tracks are shown in the field

"Tracks". With the buttons you can set, whether the track contains
monosyllabic (“Words”) or polysyllabic (Numbers) test material.

Hearing aid
You can mark for each page whether a hearing aid was used in the examination.

 The use of hearing aids or masking signal is noted on the printout.

Speech in the noise

You can also use the speech test with background noise. This function is only active in the free
field. Then the masking noise comes from the same side as the speech signal. According to
the recommendations, the signal volume is pre-set to 65dB and the noise volume to 60dB.

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6 Software reference

Test list selection

Fig. 23 Track selection

The list shows you the tracks available for the selected speech test. Select the track to be
played by clicking with the left mouse button or start it directly by double-clicking. Use the
button to randomly select a test list of the same group (numbers / words).
Speech test selection

Fig. 24 Speech test selection

If several speech tests have been set in the options (see section 6.5.3), you can switch the
desired language test in the field below the track list. The track list is then updated accordingly.

6.4.1 Examination procedure

➢ Select the track.
➢ Select the side to be examined.
➢ Select the coupler and the volume / masking.
➢ Start the measurement with the play button.

Fig. 25 Speech audiometry controls

To address the patient and listen to the useful signal, activate the listener. The progress of the
track is displayed as a green bar. If the recognition is correct, the examiner confirms the word
by pressing the "Y" key or by clicking the "Catched" button.

 The track must run completely; when stopped, the current measurement is deleted.

For older or slower patients, the "F10" key can be pressed after each word or
 "Pause" can be clicked to allow the patient to respond more slowly. The track is
continued by repeatedly pressing the "F10" key or clicking on "Pause".

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 6 Software reference

6.4.2 Auto Pause option

If the option "Auto Pause" is selected, the playback pauses after each word (see section 6.5.3).
To resume the track, press the "Catched" button if the patient understands the word or the

"Forward" button if not.

6.4.3 Masking
The masking is selected with the key "F8" or by clicking on the button. The type of masking
can be set in the options:
- Manual masking
- Floating maksing

6.4.4 Discomfort threshold

After the patient has reached the discomfort threshold, the marker can be set by clicking on
the button .

6.4.5 Overlay of the tone audiograms

When you are in speech audiometry, you can click on the eye to open a new window in which
the currently displayed tone audiograms are shown. You can scale or move this window as
you wish.

Fig. 26 Speech audiometry with superimposed tone audiograms

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6 Software reference

6.4.6 Note on the hearing aid check

For each examination, you can save a speech audiogram per coupler and speech group
(words / numbers). You can use the fade-in function to document the hearing aid examination.
To do this, proceed as follows:
➢ Start an examination without a hearing aid and save it.

➢ Start a new examination (button ) with hearing aid (button ) and save it.
➢ Overlay the measurement without hearing aid by selecting it in the measurement list
(middle, top) and displaying it with the magnifying glass .
The results of the displayed measurement are shown in brackets in the table below
the audiograms.

Fig. 27 Measurement with hearing aid with superimposed measurement without hearing aid

➢ You can print this view in the Report menu.

Fig. 28 Printout with superimposed measurement without hearing aid

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 6 Software reference

6.5 Options
By pressing the "O" key or by clicking on the upper field with the right mouse button, the
Options button appears. This is clicked with the left mouse button and the options window
appears. The following can be selected by clicking on the tabs:

6.5.1 Audiometer settings

If your device was delivered with several couplers, you can select the couplers used under AC
(for air conduction) and BC (for bone conduction). Different air and bone conduction couplers
can be used with the audiometer. The calibration values for those are stored in the device and
are shown in the point 15.2 of this manual.

It is essential to ensure that the coupler used has also been calibrated on the unit.
! Please ask your dealer about this.

Furthermore, the following are displayed:

➢ Month and year of the next calibration (1x per year)
➢ Version number of the audiometer firmware
➢ Internal unit ID
➢ Internal unit temperature

6.5.2 Control

Fig. 2 Individual adaptation of the keyboard layout

Here, the key assignments (hotkeys) can be individually adjusted. In these instructions, the
factory assignment is always given as a reference.
To assign a new key to a function, click with the mouse in the corresponding field and then
press the desired key.

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6 Software reference

6.5.3 Settings

Fig. 3 Settings for audiometry

6.5.3.1 General Settings

➢ Show Mode: Viewing workstation (no communication with diagnostic devices).
➢ Patient response: If activated, the marker in the audiogram is automatically set when
the patient button is pressed.

➢ AudioControl Keyboard: When using the additional audio keyboard .

➢ Active FF: Here you can select whether the active or passive outputs are used for the
free-field measurement.

6.5.3.2 Design
➢ Age-dependent norm curve: Setting whether the age-dependent norm range should be
highlighted in green in the audio audiogram.
➢ Color settings for superimposed measurements (left and right audiogram).

6.5.3.3 Tone Audiometry

➢ Safety threshold: Volume limitation for patient safety. Higher levels must be activated
manually.
➢ Step size of the level increase: either 5 dB or 1 dB.
➢ Masking: "manual" or "floating". With "floating", the level differences (between masking
and signal) for airline and bone conduction can be selected.
➢ Frequency change: Amount of level jump in case of frequency change.
➢ Fast Select: If activated, frequency and level in the audio audiogram can be selected
conveniently with a mouse click. A crosshair helps with the setting.
➢ Auto Freq: Setting whether the frequency should be changed automatically after a
confirmed patient response. Click on the arrow <-- or --> to select the starting direction
of the frequency change (from 1kHz upwards or downwards).

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 6 Software reference

6.5.3.4 Speech Audiometry

➢ Auto Pause: Automatically pause playback during the speech test.
➢ Random Play of items: Play items of each speech test list in random order.

 If you are interested in these options, please contact your service.

➢ Source of speech files: You can select:

a) Internal memory: the speech files are stored in a folder structure as wave files
on the internal SD card of the device.
If speech files are found, the status "Green" is displayed. If "Red", no voice files
are available.
The button can be used to access the internal SD card. This should
only be done by appropriately trained personnel.
b) CD player: Speech is transmitted to the audiometer via an external CD player
and line-in. The level for the input signal can be changed via the green bar.
To do this, the test noise is started on the CD player (e.g. for the speech
intelligibility test Track 31). The signal is displayed in the middle bar in green,
yellow, red gradient. In the upper bar ("Vol"), the volume is selected with a
mouse click so that the status display below just changes from red to green.
Finally, confirm with OK. A message appears in English asking whether the
data should be saved in the EEPROM.
c) Microphone: The doctor's microphone is used (not calibrated!).
➢ Speech Testing: To configure the speech tests from the SD card.

o Press to add a new entry.

o Assign any name in the "Name" field for this speech test.
o Select the playback option:
▪ Normal: Only the speech signal is used by the speech file. The
masking noise is generated in the device.
▪ Noise from audio file: The left channel of the audio file is used as
masking noise.
▪ Binaural: Both channels of the file are used (binaural).
o Select which folder from the SD card is to be used for this speech test.

o Press to remove an entry.

You can use the same speech test from the SD card in several configurations (e.g.
 normal with masking noise and binaural).

Use the country abbreviations (DE), (FR) or (IT) in the name to determine the
 language of the test material.

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6 Software reference

6.5.3.5 Reports
➢ Hearing loss Röser: Setting whether the percentage hearing loss according to
Boenninghaus and Röser should appear on the printouts of the sound audiogram.
➢ Hearing loss CPT-AMA: Setting whether the percentage hearing loss according to
CPT-AMA should appear on the printouts of the sound audiogram.
➢ Weber / Rinne: Setting whether the results of the Weber or Rinne test should appear
on the printouts of the sound audiogram.
➢ Social Index (CH): Setting whether the hearing loss according to the Sozialindex
(according to Swiss expert guidelines) as well as the total hearing loss should appear
on the printouts of the speech audiogram.
➢ Hearing loss speech (DE): Setting whether the hearing loss from the speech audiogram
(according to Boenninghaus & Röser 1973) should appear on the printouts of the
speech audiogram.
➢ Speech audiogram combined: Setting whether the speech audiogram should be printed
combined or for left and right ear separately (see section 6.2.4).
➢ Legend: Setting whether a legend of the colours and symbols used should appear on
the printouts of the speech audiogram.

Page 54
 7 Overview of the symbols, characters and keys used

7 Overview of the symbols, characters and keys used

7.1 Audio audiometry symbols

Right Test Links

 Air conduction 

 Bone conduction 

 Free field 

Air conduction with

 
masking
Air conduction with
-- masking --
(contra side)
Bone conduction with
[ ]
masking
Bone conduction with
^^ ^^
masking (contra side)

 SISI 

 Langenbeck noise 

 Langenbeck tone 

 Stenger 

 Fowler 

 Discomfort threshold 

 Uncertain measured value 

__ Tinnitus __

Tinnitus masking

Page 55
7 Overview of the symbols, characters and keys used

7.2 Symbols Speech Audiometry

Right Test Links
 Numbers, air conduction 
 Numbers, bone conduction 
 Numbers, free field 
 Words, air conduction 
 Words, bone conduction 
 Words, free field 
 Sentences, air conduction 
 Sentences, bone conduction 
 Sentences, free field 

7.3 Key combinations (factory setting)

Programme control

L Left side
R Right side
 Reduce volume
 Increase volume
 Reduce frequency
→ Increase frequency
Image Decrease masking level
Image Increase masking level
O Options (open settings window)
P Patient Manager
Space bar Switch output on or off (depending on setting of Continuous tone)
ESC Close window / Exit programme
M Loading an examination
S Saving an examination
N New investigation
D Printing the examination (first opens a selection window)
E Overlay an examination into the current
F1 Help

Page 56
 7 Overview of the symbols, characters and keys used

Output control

F5 Air conduction
F6 Bone conduction
F7 Free field
F8 Masking noise
F4 Microphone

Sound audiometry

1 Pulsating signal
2 Wobble tone
3 Continuous tone
4 Discomfort threshold
5 SISI
6 Stenger
7 Langenbeck
8 Fowler
9 Recommended tests
F Safety threshold
Y Record measured value
X No measured value
C Uncertain measured value

Speech audiometry

F9 Play
F10 Pause
F11 Stop

Page 57
8 Cleaning and care instructions

8 Cleaning and care instructions

It is advisable to disinfect the headphones and the button after each patient contact. For this
purpose, we recommend PlastiSept eco Wipes FP - alcohol-free disinfection wipes from
ALPRO MEDICAL GmbH.
The pads of the headphones should be replaced within a reasonable time frame.
The eAUDIOUSB is resistant to most surface disinfectants. However, the disinfectant must not
contain the following ingredients:
• Concentrated organic and inorganic acids
• Chloramides, phenol derivatives or anionic surfactants

Only clean and disinfect the unit when it is switched off. Make sure that no liquid
enters the unit. To clean or disinfect the surface of the unit, use a soft cloth and the
 cleaning and disinfecting agents recommended in the chapter 8.2 chapter, use a
soft cloth and the cleaning agents and disinfectants recommended.

When cleaning and disinfecting, follow the instructions of the manufacturers of the
 agents. The measures described do not replace the respective internal regulations
for cleaning and disinfection.

8.1 Recommended disinfectants

Disinfectant Manufacturer
Sekusept PLUS Henkel, Düsseldorf
GIGASEPT FF Schülke & Mayr, Norderstedt
PRONTOCID Brown, Melsungen

8.2 Recommended surface disinfectants

Disinfectant Manufacturer
PlastiSept eco Wipes Alpro Medical GmbH
Incidin Plus Henkel, Düsseldorf
TERRALIN Schülke & Mayr, Norderstedt
QUATOHEX Brown, Melsungen

Do not use disinfectants containing aldehyde and amine on the same unit to
 prevent discolouration.

Page 58
 9 Maintenance and service

9 Maintenance and service

After each maintenance measure and after one year, a safety and metrological check (STK or
MTK) is recommended in accordance with the applicable laws.

9.1 Function test

• The unit performs a self-test every time it is started. Errors are displayed to the user.

If the unit is not recognised, check the connection to the PC and send it in for
 verification if necessary.

9.2 Visual inspection

• Check the unit for external damage. Particularly check the following:
- USB cables
- Power supply unit and cable
- Cable and housing of the couplers used
- Housing

• Check the presence and legibility of the type plate and the warning and connection
instructions.

9.3 Electrical safety

➢ The electrical safety test must be carried out and documented in accordance with DIN
EN 62353.

9.4 Metrological control

➢ The air and bone conduction couplers used as well as the free-field loudspeakers are
to be checked for accuracy using the appropriate calibration equipment. Take into
account the RETSPL or RETFL values of the respective couplers.

Circuit diagrams, component lists, descriptions or other information will be made

available to the maintenance personnel, provided that BioMed Jena GmbH
 designates the parts as repairable. The documents can be requested as a service
manual.

Page 59
10 Troubleshooting

10 Troubleshooting
o Couplers used not found
Especially after the initial installation (or when using a loaner device), the following error
message may occur:

Fig. 4 Error message: Headphones not found

The reason is an inconsistency in the settings file. To rectify this, please proceed as
follows:
➢ Open the options (see section 6.5)
➢ Check the settings in the fields "AC" or "BC".

➢ Apply the settings by clicking on .

o Saving error (GDT)

The following error may occur when saving if the GDT interface is active:

Fig. 5 Error 8 (or Error 5) when saving

This error occurs if the export file of the GDT interface is either write-protected or is still
being used by the administration software.
Check the write protection of the export file or try to save the examination again at a later
time.

The examination data are stored in the database in any case. Only the transmission
 of the examination parameters to the administration software may be disturbed by
this error.

Page 60
 10 Troubleshooting

o Speech audiometry: words are not displayed

The programme searches in the folder
[(public)DOCUMENTS]\BioMed Jena\eAUDIO\Sprachtests
for a text file with the same name as the chosen speech test (for configuration and naming
of speech tests see page 53).
Ex.: The Freiburger speech test is installed as "Freiburger". The corresponding text
file (see above) must therefore be called "Freiburger.txt".
The file can also be created for other speech tests on request.

o Speech audiometry: AutoPause does not work

See previous problem. The information for the AutoPause is in the same file as the words
to be displayed.
On request, an AutoPause can also be offered for other language tests. Please contact
your service provider.

o Speech audiometry: Percentages are not correct

By default, the software counts in 10% steps for numbers (multi-syllables) and in 5% steps
for words (single-syllables).
To adapt these steps to the language test you are using, contact your service.

o Update not possible

If the software cannot access the update server, this error message appears. Please make
sure that the FTP port 21 is enabled in your local firewall.

o Database limit
For Access databases (*.MDB) the limit is 2 GB. You can convert the database to a
Firebird database (*.FDB) with a tool from BioMed Jena GmbH. With this software you
can also merge different databases that were connected via GDT.

The use of FDB databases is only possible in combination with the

 eDiagnosticManager!

o Support information
In order to help you as quickly as possible with troubleshooting, always state the product
ID and the software version when making enquiries. You can see the product ID in the
options on the right-hand side. The version of your software can be seen in the title bar of
the main programme.

Page 61
11 Accessories and spare parts list

11 Accessories and spare parts list

11.1 Accessories
Article number Designation
028.00.10.012 Speaker Behringer Monitor 1C
028.00.10.002 Air conductor Sennheiser HDA 300 für Hochtonaudiometrie
028.00.10.006 Bone conductor B 81
028.00.10.005 Bone conductor B 71
028.00.10.009 Patient response
028.00.10.003 Headset (doctor's microphone and monitoring headphones)
028.00.10.004 patient microphone
028.00.10.014 IP30 Phones
028.00.10.015 Air conductor DD65v2

11.2 Spare parts

Article number Designation
028.00.10.007 Head clamp
028.00.10.008 Cable
028.00.10.011 Power supply
028.00.10.013 Speaker cable
028.00.10.016 Sennheiser HDA 300 Cable
028.00.10.017 Sennheiser HDA 300 Head band
028.00.10.018 DD65V2 head phones
028.00.10.021 Cable for DD65V2 with one-sided cable
028.00.10.023 Cable for DD65V2 with cable on both sides
028.00.10.024 B81/B71 Replacement pads (10 pcs.)
028.00.10.026 Headband RadioEar DD65
028.00.10.027 RadioEar DD450 High Frequency Headset
028.00.10.028 Cable for RadioEar B71 & B81 200 cm
028.00.10.029 Cable for RadioEar B71 & B 81 285 cm

Page 62
 12 GDT connection

12 GDT connection

12.1 General

 Tip: Use the eDiagnosticManager for configuration!

The software of the eAUDIO USB can be easily integrated into the existing practice
administration software system. The prerequisite for this is that the software supports GDT
(device data transfer).
If the GDT interface is used, patient management is carried out via the administration software.
The settings for the GDT can be selected in the ini-file. This is stored in the user's "Own
Documents" or in the public documents, e.g. "C:\Users\USER\Documents\BioMed
Jena\eAUDIO". For a standalone installation, use the AudioKIS.mdb database for the GDT.
To open the software in a specific device tab (Audio / Tymp / ABR), start the software with the
following transfer parameter:
"...\eAudio.exe" -- "/string:AUDIO"
"...\eAudio.exe" -- "/string:TYMP"
"...\eAudio.exe" -- "/string:ABR"

Example settings in the configuration file:

[Audio]
DatabaseName="C:\Users\USER\Documents\BioMed Jena\eAUDIO\AudioKIS.MDB"
Export = "C:\Users\USER\Documents\BioMed Jena\GDT\export.gdt". Path export file
Import = "C:\Users\USER\Documents\BioMed Jena\GDT\import.gdt". Path import file
Chars=1 Character set OEM or ANSI
Overwrite=TRUE True: File with extension *.gdt, otherwise *.001...
[Übernahme]
GDT = TRUE
8402_AUDIO = AUDI00 Entry in the field "8402" of the GDT file for audiometry (6 characters!)
8402_TYMP = AUDI00 Entry in the field "8402" of the GDT file at Tymp. (6 characters!)
8402_ABR = AUDI02 Entry in the field "8402" of the GDT file at ABR/BERA (6 characters!)

The following identifiers are supported:

AUDI00: General audiometry AUDI14: Sliding Frequency Bekesy
AUDI02: EEG audiometry, e.g. BERA AUDI15: Fixed Frequency Bekesy
AUDI11: Sound audiogram AUDI16: Speech audiogram
AUDI12: Fowler Test AUDI17: Dichotic Test
AUDI13: Carhart test AUDI18: Adaptive Test

Page 63
12 GDT connection

12.2 GDT 6311

You have the option of opening an examination directly from the administration software
without having to select it separately from the patient manager.
Use record type 6311 for this purpose. The following fields must be present:
Field identifier Designation Format / Content
3000 GDT ID Alphanumeric ID of the
patient
3101 Name
3102 First name
6200 and / or 8432 Examination date DDMMYYY
8439 Time of the examination HHMMSS

The use of record type 6311 only works for installations with the
 eDiagnosticManager! (eDM = TRUE in the Audio.ini, see next section)

12.3 PDF Export

It is also possible to transmit PDF files by means of the GDT. This function is active if you have
activated the automatic PDF export (PDF = TRUE in Audio.ini).
The following entries are added to the export GDT:
Field identifier Designation Format / Content
6302 Archiving number Alphanumeric entry,
corresponds to file name
6303 File format PDF
6304 File content Report
6305 Reference to file Path to PDF file

Page 64
 13 Hidden features

13 Hidden features
All settings can be found in the ini file:
C:\Users\USER\Documents\BioMed Jena\eAUDIO\Audio.ini
Section [Audio]
Name Function Standard Description Available in
programme
ExtRange Shows the High FALSE Shows or hides the High No
frequency Tab frequency Tab
Chars GDT character set FALSE FALSE - ANSI No
TRUE - OEM
Change the value in case
of problems with umlauts
Overwrite GDT file TRUE TRUE: *.gdt No
extension FALSE *.001 ...
ProveCal Check calibration TRUE Shows an error when No
calibration is due
ShowError Show error FALSE TRUE – Show certain No
messages error messages
OneSpeaker Free-field FALSE For customers with only 1 No
loudspeaker free-field loudspeaker.
Signal comes from the
right free field output
FF_Ton Pure tone in the FALSE FALSE - Free field is not No
free field available in sound
audiometry
FB_Show Freiburg words TRUE TRUE - Shows the No
numbers / words in the
Freiburg language test
Pages Tab Numeric Last opened tab No
ESCMin ESC function FALSE TRUE - ESC minimises No
window
FALSE - ESC terminates
software
GDTExportData Export audio data FALSE No
to GDT
CenterMasking Right line-out for FALSE For BC handset with No
masking integrated masking
(BKH10)
Direction_f Direction of the FALSE FALSE - lower Yes
automat. TRUE - higher
Frequency
change
Mask_Cont Continuous FALSE If the test signal is No
masking interrupted
Mask_MarkF Frequency marker FALSE Marking of frequency on No
for masking masking side
v2_start Audiometer TRUE For configuration without No
version device
Ki_Mon 2nd monitor for 2 Yes, if >2
paediatric monitors are
audiometry connected
Ki_ExtMon Changing the TRUE True: Enable/Disable 2 No
ndmonitor
monitor
configuration False: Don't change
display configuration

Page 65
13 Hidden features

Name Function Standard Description Available in

programme
LUE_base Basic level for 20 Level in dBHL Yes
Lüscher test
LUE_timeout Timeout for 10 Time in s after which the No
Lüscher test test stops
LUE_freq Frequencies f. 125; 250, 500; No
automat. 750; 1000;
Lüschertest 1500; 2000;
3000; 4000;
6000; 8000
Rep_Speech_Combi Combined printout FALSE TRUE – combined reports Yes
for speech FALSE – single reports
audiograms per ear
Rep_CPT CPT-AMA hearing FALSE Prints the hearing loss Yes
loss acc. to CPT-AMA tables
Rep_Roes Roeser hearing TRUE Prints the hearing loss Yes
loss acc. to Roeser 1973/1980
tables
Rep_WeRi Weber / Rinne TRUE Prints results of Weber / Yes
results Rinne test
Rep_Speech_Leg Speech FALSE Add a legend to speech Yes
audiogram legend audiograms
Rep_HV_Speech Hearing loss for FALSE Prints the hearing loss for Yes
Speech speech audio acc. to
Roeser
Rep_SI Sozialindex (CH) FALSE Prints the hearing loss Yes
acc. to ‘Sozialindex’
Rand_Play Random Playback FALSE True - play items in Yes
of items in test list speech track randomly
False – play items in
speech track one after
another

Section [Übernahme]
Name Function Standard Description Available in
programme
GDT GDT File Exchange FALSE Activate GDT No
PDF Export FALSE TRUE export PDF after No
saving
PDFPath String (“…”) Directory for PDF export No
XDO XDO File Exchange FALSE XDO Interface (export only) No

XDOPath String (“…”) Directory for XDO export No

XDOFile String (“…”) XDO export file name No

(export.xdo)

Section [USER]
Name Function Standard Description Available in
programme
eDM eDiagnosticManager FALSE Use eDM instead of patient No
manager
LogoPath Path to individual logo String (“…”) Path to .bmp, .png or No
file .jp(e)g file, used for splash
and reports

Page 66
13 Hidden features

Page 67
14 Literature (exemplary)

14 Literature (exemplary)
[1] Dieter Mrowinski Günther Scholz: Audiometry; Publisher: Thieme, Stuttgart 2011 4th,
updated and extended edition; ISBN-10: 3131180048
[2] Hahlbrock, Karl-Heinz: Speech audiometry; Georg Thieme Verlag, Stuttgart 1970
[3] Ernst Lehnhardt, Roland Laszig; publication date 12.08.2009; language German; ISBN
978-3-13-369009-6; publisher Georg Thieme Verlag
[4] Mehmke, S.; Tegtmeier, W.: Kleines Wörterbuch der Audiologie; C.H.F. Muller GmbH,
Hamburg 1972
[5] Niemeyer, Wolfhart: Praktikum Kleines der Audiometrie; Georg Thieme Verlag,
Stuttgart 1976
[6] Plath, Peter: Das Hörorgan und seine Funktion Einführung in die Audiometrie; Karl
Marhold Verlag, Berlin 1976
[7] Deutsche Gesetzliche Unfallversicherung e.V. (Hrsg.): Empfehlung für die
Begutachtung der Lärmschwerhörigkeit (BK-Nr. 2301) – Königsteiner Empfehlung –
Update 2020. Deutsche Gesetzliche Unfallversicherung e.V., Berlin 2020

Page 68
 15 Specifications

15 Specifications

15.1 Parameter
Parameter Value

Number of signal channels 2 separate and identical signal channels

Attenuator 1 dB or 5 dB
Total harmonic distortion (THD+N)
Air conduction <3%
Bone conduction <6%
Frequency range pure tone audiometry
Air conduction HDA 280 / DD65v2 125 - 8000Hz
Air conduction HDA 300 125 - 16000 Hz
Bone conduction B81 250 - 8000 Hz
Frequency accuracy pure tone audiometry +/- 1 %
Signal shapes pure tone Continuous tone
Pulsed tone
Frequency modulation (sweep) according to
EN 60645-1 section 6.2
Amplitude modulation (SISI) 5, 3, 2, 1 dB
Masking pure tone Contralateral free or floating
- Broadband noise
- Narrowband noise,
Bandwidth: 1/3 octave (according to EN
606451 -section 6.4, 8.5 and Tab. 4)
Masking speech test Contralateral free or floating
- Speech simulating noise (frequency-
weighted noise according to
EN60645- 2 Section 13)
- Broadband noise
Speech test Monaural and Binaural
- Speech CD/ WAV files
- External speech test via any
connectable signal source
Suprathreshold tests SISI, Langenbeck, Stenger, Fowler,
Lüscher, tinnitus, tinnitus masking
Free field (passive) 3 passive boxes 4 Ohms (400 mV)
Free field (active) 2 active loudspeaker boxes
Warm-up time 5 min.
Line In Max. 1 VRMS

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16 Disposal

15.2 Reference threshold level for the transducers used

Reference threshold levels for the different transducers can be found in the service manual.
To get the service manual, contact your service partner or BioMed Jena GmbH.

16 Disposal
• All shipping packaging can be fully recycled or returned to your supplier for reuse.
• The "eAUDIOUSB " unit does not contain any hazardous substances.
• The housing is fully recyclable.
• The components and materials of the appliance must be carefully separated and
disposed of.
• The components are RoHS compliant.

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 17 Technical data

17 Technical data
Power supply External power supply SMDA51-T03
Voltage 100...240VAC
Mains frequency 47...63Hz
Power consumption 42W max.
Warm-up time 5min. after complete acclimatisation to ambient
temperature
Environmental conditions
Transport -10 .. 50°C
5%..90 % Humidity without condensation
700..1060 hPa Air pressure
Operation +10 .. 40°C
5.. 80% humidity without condensation
at 700..1060 hPa air pressure
Dimensions ca. 310 x 205 x 45 mm (W x D x H)
Weight approx. 1kg without accessories
Protection class (EN60601-1) II
Degree of protection Type BF
Protection class IPX0
Classification IIa according to Annex II EC Directive 93/42/EEC
Applied standards EN 60645-1 Class 2
EN 60645-2 Class B (- E, depending on regional
regulations)
CE marking CE 0124

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18 EMC - Guidelines

18 EMC - Guidelines
Modifications to the eAUDIOUSB not expressly approved by BioMed Jena GmbH could result
in EMC problems with it or with other equipment. The eAUDIO USB(hereinafter also referred to
as "ME device") is designed to comply with the relevant EMC requirements. Compliance with
these requirements has been verified. The device is intended for use in professional healthcare
(practices, clinics, ...). When installing and commissioning the system, the following EMC
instructions must be observed.

Unexpected or undesirable behaviour of the unit or system may occur if portable

! telephones or other devices that operate on radio frequencies are operated in the
vicinity.

Do not place the unit or system next to or on top of other equipment for operation.

! If such an arrangement of units is necessary, the proper functioning of the unit or

system must be checked in the respective case.

Guidelines and manufacturer's declaration - Electromagnetic emissions

The eAUDIOUSB is intended for operation in an environment as specified below. The customer or the user of the eAUDIOUSB
should ensure that it is operated in such an environment.
Interference emission
Concordance Electromagnetic environment - Guidance
measurements
HF emissions Group 1 The eAUDIOUSB uses RF energy only for its internal
According to CISPR 11 function. Therefore, its RF emission is very low and it is
unlikely to interfere with neighbouring electronic
equipment.
HF emissions Class B The device is intended for use in professional healthcare
According to CISPR 11 (practices, clinics, ...).
Transmissions from Agrees
Harmonics
according to IEC 61000-3-2
Transmissions from Agrees
Voltage fluctuations / flicker
according to IEC 61000-3-3

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 18 EMC - Guidelines

Guidelines and manufacturer's declaration - Electromagnetic immunity

The eAUDIO USBis intended for use in the electromagnetic environment specified below. The customer or the user of the
eAUDIO USBshould ensure that it is used in such an environment.
Electromagnetic environment -
Immunity tests IEC 60601 test level Compliance level
Guidelines
Discharge of static ± 8 kV Contact discharge ± 8 kV Contact discharge Floors should be made of wood,
Electricity (ESD) ± 15 kV Air discharge ± 15 kV Air discharge concrete or ceramic tiles. If the
according to IEC 61000-4- floor is covered with synthetic
2 material, the relative humidity
must be 30%.
Fast transient ± 2 kV for mains lines ± 2 kV for mains lines The quality of the supply voltage
electrical disturbances/ ± 1 kV for input and ± 1 kV for input and should correspond to that of a
Bursts Output lines Output lines typical business or hospital
according to IEC 61000-4- environment.
4
Surges (Surges) ± 1 kV ± 1 kV The quality of the supply voltage
according to IEC 61000-4- Push-pull voltage Push-pull voltage should correspond to that of a
5 ± 2 kV ± 2 kV typical business or hospital
Common mode voltage Common mode voltage environment.
Voltage dips, Voltage dips Voltage dips The quality of the supply voltage
Short-term interruptions should correspond to that of a
i) - 100% slump for ½ i) - 100% slump for ½
and fluctuations in the typical business or hospital
period period
supply voltage environment.
according to IEC 61000-4- - 100% slump for 1 period - 100% slump for 1 period If the user of the
11 eAUDIO USBrequires continued
ii) - 25% slump for ii) - 25% slump for
operation even when power
25/30periods 25/30periods
interruptions occur, it is
Voltage interruptions Voltage interruptions recommended that the eAUDIO
beUSB powered from an
- 100% interruption for - 100% interruption for
uninterruptible power supply or a
250/300 periods 250/300 periods
battery.
Magnetic field during 3 A/m 3 A/m Magnetic fields at the mains
Supply frequency frequency should correspond to
(50 Hz) 30A/m for magnetically typical values found in business
according to IEC 61000-4- sensitive devices and hospital environments.
8
NOTE UIfT the AC mains voltage is too high prior to applying the test levels

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18 EMC - Guidelines

Guidelines and manufacturer's declaration - Electromagnetic immunity

The eAUDIO USBis intended for use in the electromagnetic environment specified below. The customer or the user of the
eAUDIO USBshould ensure that it is used in such an environment.
Immunity test IEC 60601 - Test Compliance level Electromagnetic environment - Guidelines
level
3 V rms Portable and mobile radios should not be used
at a distance from the eAUDIOUSB, including
150 kHz to 80 MHz
leads, less than the recommended separation
AM with 1 kHz
distance calculated using the equation
6 Vrms at the following applicable to the transmit frequency.
discrete frequencies
for lines >3m:
Recommended protective distance:
V 1= 3 V
6.765-6.795MHz,
13.553-13.567MHz,
Conducted RF
26.957-27.283MHz,  3,5 
disturbances 40.66-40.7MHz (ISM) d =  P
according to IEC  V1 
1.8-2.0MHz,
61000-4-6 3.5-4.0MHz,
5.3-5.4MHz,
7.0-7.3MHz,  3,5 
10.1-10.15Mhz, d =  P for 80 MHz to 800 MHz
Radiated 14.0-14.2MHz,  E1 
18.07-18.17MHz,
HF disturbance 21.0-21.4MHz,
24.89-24.99MHz,
variables
7
d =  P
28.0-29.7MHz,
according to IEC 50.0-54.0MHz for 800 MHz to 2.5 GHz
61000-4-3  E1 
3 V/m, 80 MHz to 2.7
GHz, 80% AM, 1kHz
with P as the nominal power of the transmitter
385MHz, PM 18Hz, Like test level
27V/m in watts (W) according to the transmitter
manufacturer's specifications and d as the
450MHz, FM 1kHz,
28V/m recommended protective distance in metres
(m).
710, 745, 780MHz,
PM 217Hz, 9V/m The field strength of stationary radio
transmitters should be aless than the
810, 870, 930MHz,
PM 18Hz, 28V/m compliance level at all frequencies according
to an on-site survey.b
1720, 1845,
1970MHz, PM 217Hz, Interference is possible in the vicinity of
28V/m
devices bearing the following symbol.
2450MHz, PM 217Hz,
28V/m

5240, 5500,
5785MHz, PM217Hz,
9V/m
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not be applicable in all cases. The propagation of electromagnetic quantities is affected by
absorption and reflection from buildings, objects and people.
aThe field strength of stationary transmitters, such as base stations of radio telephones and land mobile radios,
amateur radio stations, AM and FM radio and television transmitters cannot be predicted theoretically
with accuracy. To determine the electromagnetic environment with respect to stationary transmitters, a study of
the site should be considered. If the measured field strength at the location where the eAUDIOUSB is
used exceeds the compliance levels above, the eAUDIO should beUSB observed to demonstrate proper
operation. If unusual performance characteristics are observed, additional measures may be required, such as
changing the orientation or location of the eAUDIOUSB.
bOver the frequency range from 150 kHz to 80 MHz, the field strength should be less than [V 1] V/m.

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 18 EMC - Guidelines

Recommended protective distances between portable and mobile

HF telecommunications equipment and the eAUDIOUSB
The eAUDIO USBis intended for use in an electromagnetic environment in which RF disturbances are controlled. The customer
USB
or the user of the eAUDIO can help avoid electromagnetic interference by maintaining the minimum distance between
portable and mobile RF communication devices (transmitters) and the eAUDIO USB, depending on the output power of the
communication device, as indicated below.
Protective distance depending on the transmission frequency
m
Nominal power 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
of the transmitter
 3,5   3,5  7
W
d =  P d =  P d =  P
 V1   E1   E1 
0,01 0,12 0,12 0,23
0,1 0,37 0,37 0,74
1 1,17 1,17 2,34
10 3,69 3,69 7,38
100 11,67 11,67 23,34
For transmitters whose maximum power rating is not specified in the above table, the recommended separation distance d
in metres (m) can be determined using the equation associated with the respective column, where P is the maximum power
rating of the transmitter in watts (W) as specified by the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2 These guidelines may not be applicable in all cases. The propagation of electromagnetic quantities is affected by
absorption and reflection from buildings, objects and people.

Page 75
19 Declaration of conformity

19 Declaration of conformity

KONFORMITÄTSERKLÄRUNG / DECLARATION DE CONFORMITE

DECLARATION OF CONFORMITY / DICHIARAZIONE DI CONFORMITA
Name und Adresse der Firma BioMed Jena GmbH
Nom et adresse de l’entreprise Biomedizinische Technik
Nome e indirizzo della ditta Am Egelsee 1
Name and address of the firm 07743 Jena
GERMANY

Wir erklären in alleiniger Verantwortung, dass / Nous déclarons sous notre propre responsabilité que /
Dichiariamo sotto nostra responsabilità che / We declare under our sole responsibility that

das Medizinprodukt eAUDIOUSB……………………….…Art. Nr. 28-20xx.xxx

le dispositif médical
il dispositivo medico
the medical device
Bezeichnung, Typ oder Modell, Chargen- oder Seriennummer, ev. Herkunft und Stückzahl
Nom, type ou modèle, numéro de lot ou série, év. source et nombre d'exemplaires
Nome, tipo o modello, numero di lotto o i serie, ev. fonte e numero di esemplari
Name, type or model, batch or serial number, possibly sources and number of items

der Klasse / de la classe / della classe / of IIa

class ...............................................................................................
Nach Anhang IX der Richtlinie 93/43/EWG / selon l'annexe IX de la directive 93/42/CEE
/
secondo l'allegato IX della direttiva93/24/CEE / according to annex IX of direct.
3/42/EEC

allen Anforderungen der Medizinprodukte-Richtlinie 93/42/EWG (od. 90/385/EWG) und der Richtlinie 2011/65/EU
(RoHS II) entspricht, die anwendbar sind / remplit toutes les exigences de la directive sur les dispositifs médicaux
93/42/CEE (ou 90/385/CEE) et la directive 2011/65/EU (RoHS II) qui le concernent / soddisfa tutte le disposizioni
della direttiva 93/42/CEE (opure 90/385/CEE) e la direttiva 2011/65/EU (RoHS II) che lo riguardano / meets all the
provisions of the directive 93/42/EEC (or 90/385/EEC) and the directive 2011/65/EU (RoHS II) which apply to it.

Konformitätsbewertungsverfahren EG Richtlinie „Medizinprodukte“ 93/42/EWG

Procédure d’évaluation de la conformité Anhang II
Procedimento di valutazione della conformità
Conformity assessment procedure

Konformitätsbewertungsstelle (93/42/EWG) DEKRA Certification GmbH, Handwerkerstr. 15

Organe resp. de l'évaluat. de la conformité (93/42/EWG) 70565 Stuttgart, Germany
Organo incaric. della valutaz. della conform. (93/42/EWG) Notified Body 0124
Notified Body (if consulted)

Das Produkt wird gekennzeichnet mit

Le produit possédé le marquage
Il prodotto è caratterizzato inoltre
The product is marked with the sign

Zeitlich unbegrenzt gültig für die im Zeitraum 2021-2023 hergestellten Produkte.

Validité non limitée pour production en 2021-2023.
Validità illimitata per le unità prodotte in 2021-2023.
Validity unlimited for units produced in 2021-2023.

Jena, 06.04.2021
Ort, Datum / Lieu, date / Luogo, data / Place, date René Schüler / Geschäftsführer (CEO)
Name und Funktion / Nom et fonction /
Nome e funzione / Name and function

Page 76
 20 Contact

20 Contact

BioMed Jena GmbH

Am Egelsee 1
D-07743 Jena

Tel: +49 (0) 3641 - 356900

Fax: +49 (0) 3641 - 356909

Mail: [email protected]
Internet :www.biomed-jena.de

Page 77