SIST EN IEC 60118-9:2020

SLOVENSKI STANDARD
SIST EN IEC 60118-9:2020
01-januar-2020
Elektroakustika - Slušni pripomočki - 9. del: Metode za merjenje tehničnih lastnosti
kostno prevodnih slušnih pripomočkov (IEC 60118-9:2019)
Electroacoustics - Hearing aids - Part 9: Methods of measurement of the performance
characteristics of bone conduction hearing aids (IEC 60118-9:2019)
Elektroakustik - Hörgeräte - Teil 9: Verfahren zur Messung der
Übertragungseigenschaften von Knochenleitungshörgeräten (IEC 60118-9:2019)
Électroacoustique - Appareils de correction auditive - Partie 9: Méthodes de mesure des
caractéristiques fonctionnelles des appareils de correction auditive à conduction osseuse
(IEC 60118-9:2019)
Ta slovenski standard je istoveten z: EN IEC 60118-9:2019
ICS:
11.180.15 Pripomočki za gluhe osebe in Aids for deaf and hearing
osebe z okvaro sluha impaired people
17.140.50 Elektroakustika Electroacoustics
SIST EN IEC 60118-9:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN IEC 60118-9:2020

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SIST EN IEC 60118-9:2020


EUROPEAN STANDARD EN IEC 60118-9

NORME EUROPÉENNE

EUROPÄISCHE NORM
November 2019
ICS 17.140.50

English Version
Electroacoustics - Hearing aids - Part 9: Methods of
measurement of the performance characteristics of bone
conduction hearing aids
(IEC 60118-9:2019)
Électroacoustique - Appareils de correction auditive - Partie Elektroakustik - Hörgeräte - Teil 9: Verfahren zur Messung
9: Méthodes de mesure des caractéristiques fonctionnelles der Übertragungseigenschaften von
des appareils de correction auditive à conduction osseuse Knochenleitungshörgeräten
(IEC 60118-9:2019) (IEC 60118-9:2019)
This European Standard was approved by CENELEC on 2019-10-21. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.


European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2019 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
 Ref. No. EN IEC 60118-9:2019 E

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EN IEC 60118-9:2019 (E)
European foreword
The text of document 29/1025/FDIS, future edition 2 of IEC 60118-9, prepared by IEC/TC 29
"Electroacoustics" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
EN IEC 60118-9:2019.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2020-07-21
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2022-10-21
document have to be withdrawn

Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.

Endorsement notice
The text of the International Standard IEC 60118-9:2019 was approved by CENELEC as a European
Standard without any modification.

In the official version, for Bibliography, the following notes have to be added for the standards
indicated:
IEC 60068 (series) NOTE Harmonized as EN 60068 (series)
1
IEC 60263 NOTE Harmonized as EN IEC 60263

1
 Under preparation. Stage at the time of publication: prEN IEC 60263.
2

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SIST EN IEC 60118-9:2020
EN IEC 60118-9:2019 (E)
Annex ZA
(normative)

Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments)
applies.
NOTE 1  Where an International Publication has been modified by common modifications, indicated by (mod), the relevant
EN/HD applies.
NOTE 2  Up-to-date information on the latest versions of the European Standards listed in this annex is available here:
www.cenelec.eu.

Publication Year Title EN/HD Year
IEC 60118-0 -  Electroacoustics - Hearing aids - Part 0: EN 60118-0 -
Measurement of the performance characteristics
of hearing aids
IEC 60318-6 -  Electroacoustics - Simulators of human head and EN 60318-6 -
ear - Part 6: Mechanical coupler for the
measurement on bone vibrators

3

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IEC 60118-9

®


Edition 2.0 2019-09




INTERNATIONAL



STANDARD




NORME



INTERNATIONALE
colour

inside










Electroacoustics – Hearing aids –

Part 9: Methods of measurement of the performance characteristics of bone

conduction hearing aids




Électroacoustique – Appareils de correction auditive –

Partie 9: Méthodes de mesure des caractéristiques fonctionnelles des appareils


de correction auditive à conduction osseuse













INTERNATIONAL

ELECTROTECHNICAL

COMMISSION


COMMISSION

ELECTROTECHNIQUE


INTERNATIONALE




ICS 17.140.50 ISBN 978-2-8322-7332-6




Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale

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CONTENTS
FOREWORD . 4
INTRODUCTION . 6
1 Scope . 7
2 Normative references . 7
3 Terms and definitions . 7
4 Measurement method . 11
4.1 General . 11
4.2 Mechanical coupler . 11
4.3 Skull simulator . 11
4.4 Measurement frequency range . 11
4.5 Reporting of data . 12
5 Measurement enclosure and measurement equipment. 12
5.1 General . 12
5.2 Unwanted stimuli in the test enclosure . 12
5.3 Sound source . 12
5.4 Measurement system for the measurement of the vibratory force level
produced by a bone conduction hearing aid . 12
5.5 Direct-current measuring system . 13
5.6 Magnetic field source for ETLS and MMSL measurements . 13
6 Measurement conditions . 14
6.1 General . 14
6.2 Applying the bone vibrator to the mechanical coupler or skull simulator . 14
6.2.1 Transcutaneously coupled devices . 14
6.2.2 Bone coupled devices . 14
6.3 Control of the sound field . 15
6.3.6 Battery or supply voltage . 17
6.3.7 Settings of controls . 18
6.4 Ambient conditions. 18
6.4.1 Measurement space . 18
6.4.2 Bone vibrator, mechanical coupler and skull simulator . 18
7 Measurement procedures . 19
7.1 Frequency response curves . 19
7.2 OVFL90 frequency response curve . 19
7.3 Full-on acousto-mechanical sensitivity level frequency response . 20
7.4 Basic vibratory force level frequency response . 21
7.4.1 Measurement procedure . 21
7.4.2 Frequency range . 21
7.5 Total harmonic distortion . 21
7.6 Equivalent input noise . 22
7.7 Battery current . 22
7.8 Measurements for hearing aids having an induction pick-up coil . 22
7.8.1 General . 22
7.8.2 Equivalent test loop sensitivity (ETLS) . 23
7.8.3 Maximum HFA magneto-mechanical sensitivity level (HFA- MMSL) of
induction pick-up coil . 23
8 Maximum permitted expanded uncertainty of measurements . 23

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Bibliography . 26

Figure 1 – Example of a bone coupled device (hearing aid with integral bone vibrator)
mounted on a skull simulator . 15
Figure 2 – Example of a transcutaneously coupled device (spectacle hearing aid with

an integral bone vibrator mounted in the spectacle arm) under measurement . 16
Figure 3 – Example of a transcutaneously coupled device (hearing aid with external
bone vibrator) mounted on the mechanical coupler . 17
Figure 4 – Example of OVFL90 curve and basic force level frequency response curve . 20
Figure 5 – Relationship between tolerance limits, corresponding acceptance intervals
and the maximum permitted uncertainty of measurement, U . 24
MAX

Table 1 – Resistors and open circuit voltages for zinc-air battery simulators . 18
Table 2 – Distortion test frequencies and input sound pressure levels . 22
Table 3 – Example uncertainty budget . 25

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INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________

ELECTROACOUSTICS –
HEARING AIDS –

Part 9: Methods of measurement of the performance
characteristics of bone conduction hearing aids

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as "IEC
Publication(s)"). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 60118-9 has been prepared by IEC technical committee 29:
Electroacoustics.
This second edition cancels and replaces the first edition published in 1985. This edition
constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous
edition:
a) includes bone coupled devices measured on a skull simulator;
b) measurement frequency range increased to 8 000 Hz for bone coupled devices.

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IEC 60118-9:2019 © IEC 2019 – 5 –
The text of this International Standard is based on the following documents:
FDIS Report on voting
29/1025/FDIS 29/1029/RVD

Full information on the voting for the approval of this International Standard can be found in
the report on voting indicated in the above table.
This document has been drafted in accordance with the ISO/IEC Directives, Part 2.
A list of all parts in the IEC 60118 series, published under the general title Electroacoustics –
Hearing aids, can be found on the IEC website.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to
the specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.

IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct
understanding of its contents. Users should therefore print this document using a
colour printer.

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INTRODUCTION
IEC 60118-0 gives information on methods of measurement for air conduction hearing aids.
The majority of hearing aids in use are of this type, but a small percentage use a bone
vibrator instead of an earphone. The use of a bone vibrator requires a different method of
measuring the output from the hearing aid and also makes it impractical to measure
amplification directly in terms of acoustic gain.
Amplification in the case of an air conduction hearing aid is expressed as the difference
between the output sound pressure level in an acoustic coupler or ear simulator and the
input sound pressure level measured in a specified manner. However, with bone
conduction hearing aids, the input is in terms of sound pressure level, but the output will be
in terms of mechanical vibration measured as a vibratory force or force level.
By means of information provided in this document, the performance of hearing aids with
bone vibrator outputs which do not form an integral part of the hearing aid, for example body-
worn, behind-the-ear hearing aids, or bone conduction implant systems with an external bone
vibrator, can be measured in a similar manner to aids with air conduction outputs as
described in IEC 60118-0.
Where the bone vibrator forms an integral part of the hearing aid, or where it is attached in
some fixed manner to the hearing aid, for example a bone coupled (bone anchored) hearing
aid, its performance cannot be measured in the same way as for body-worn aids, due to the
large dimensions of the mechanical coupler. This document recommends a pressure method
of controlling the input sound pressure level to the hearing aid microphone. As an alternative
to the pressure method, storage of a test enclosure frequency response correction curve can
be used. This method is referred to as the "substitution method".

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IEC 60118-9:2019 © IEC 2019 – 7 –
ELECTROACOUSTICS –
HEARING AIDS –

Part 9: Methods of measurement of the performance
characteristics of bone conduction hearing aids



1 Scope
This part of IEC 60118 specifies methods for the measurement of bone conduction hearing
aid characteristics.
The methods described will produce a suitable basis for the exchange of information or for
direct comparison of the electroacoustical characteristics of bone conduction hearing aids.
These methods are chosen to be practical and reproducible and are based on selected fixed
parameters.
The results obtained by the methods specified in this document express the performance
under the conditions of measurement; however, the performance of the hearing aid under
practical conditions of use will depend upon a number of factors (e.g. effective load
impedance, environmental conditions, acoustical environment, etc.).
This document defines methods of measurement of characteristics of bone conduction
hearing aids both for
• transcutaneously coupled devices measured on a mechanical coupler, meeting the
requirements of IEC 60318-6, and
• bone coupled/bone anchored devices measured on a skull simulator.
NOTE 1 A skull simulator is a mechanical coupler designed to present a specific mechanical impedance to
mechanically coupled vibrator.
NOTE 2 Throughout this document, all sound pressure levels specified are referred to 20 µPa. When
appropriate, sound pressure level will be abbreviated to SPL.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their
content constitutes requirements of this document. For dated references, only the edition
cited applies. For undated references, the latest edition of the referenced document (including
any amendments) applies.
IEC 60118-0, Electroacoustics – Hearing aids – Part 0: Measurement of the performance
characteristics of hearing aids
IEC 60318-6, Electroacoustics – Simulators of human head and ear – Part 6: Mechanical
coupler for the measurement on bone vibrators
ISO 3, Preferred numbers – Series of preferred numbers
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.

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ISO and IEC maintain terminological databases for use in standardization at the following
addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
3.1
bone conduction hearing aid
wearable instrument intended to aid a person with impaired hearing using an
electromechanical transducer intended to produce the sensation of hearing by vibrating the
cranial bones
Note 1 to entry: A bone conduction hearing aid usually consists of a microphone, amplifier, signal processor, and
bone vibrator, powered by a low-voltage battery, and possibly also containing an induction pick-up coil. It is fitted
using audiometric and prescriptive methods.
Note 2 to entry: The bone vibrator of a hearing aid can be integrated in the same housing with the hearing aid,
can be driven via a cable solution and placed in a separate housing, or can be driven via an inductive link and
implanted in the skull.
Note 3 to entry: Bone conduction hearing aids can be placed on the body (body worn), behind-the-ear (BTE), or
in the mastoid area (ear level).
3.2
transcutaneously coupled hearing aid
bone conduction hearing aid using a device that is coupled by an attractive or a static force to
a human head
3.3
bone coupled hearing aid
device that is implanted or rigidly coupled to the skull bone, via a mechanical coupling or an
abutment to the human head
Note 1 to entry: A bone coupled bone conduction hearing aid is often named a bone-anchored device.
3.4
vibratory force level
VFL
twenty times the logarithm to the base 10 of the ratio of the RMS value of the force
transmitting the vibration to the reference value of 1 µN, expressed in decibels
Note 1 to entry: This note applies to the French language only.
3.5
mechanical coupler
device for measuring the vibratory force level output of a transcutaneously coupled hearing
aid, where the force level is measured by a calibrated mechano-electric transducer coupled to
the source
EXAMPLE As described in IEC 60318-6.
3.6
skull simulator
device for measuring the vibratory force level output of a bone coupled hearing aid, where the
force level is measured by a calibrated mechano-electric transducer coupled to the source
3.7
acousto-mechanical sensitivity
quotient of the vibratory force, produced on a mechanical coupler or a skull simulator by the
bone conduction hearing aid and the sound pressure at the reference point of the hearing aid

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3.8
acousto-mechanical sensitivity level
AMSL
twenty times the logarithm to the base 10 of the ratio of the acousto-mechanical sensitivity to
the reference sensitivity of 1 µN/20 µPa, expressed in decibels
Note 1 to entry: To calculate the acousto-mechanical sensitivity level from measurements made in this document,
the following formula can be used:
AMSL = VFL – Input SPL
where
VFL re 1 µN is expressed in decibels.
Note 2 to entry: This note applies to the French language only.
3.9
input sound pressure level
sound pressure level at the hearing aid reference point
3.10
basic vibratory force level frequency response curve
force level frequency response curve obtained with the gain control in the reference test
setting and with an input SPL of 60 dB
3.11
input-output characteristic
plot of the output force level, for a single frequency, measured on a mechanical coupler or a
skull simulator on the ordinate, against the sound pressure level applied to the hearing aid on
the abscissa, with equal decibel scale divisions on each axis
3.12
vertical reference
line through or on a hearing aid which is vertical when the aid is positioned as worn on a head
and a torso simulator
3.13
reference point
point on the bone conduction hearing aid chosen for the purpose of defining its position
3.14
high-frequency average
HFA
average of AMSL or VFL in decibels at 1 000 Hz, 1 600 Hz and 2 500 Hz
Note 1 to entry: This note applies to the French language only.
3.15
gain control
manually or electronically operated control for the adjustment of overall output
3.16
OVFL90
output vibratory force level for 90 dB input SPL
VFL developed on a mechanical coupler or a skull simulator with an input SPL of 90 dB with
the gain control of the hearing aid full-on
Note 1 to entry: It is recognized that the maximum output level may occur with more, or occasionally with less,
input SPL than 90 dB. However, the differences are usually small over the frequency range of interest and the
input SPL of 90 dB makes automatic recording of the OVFL90 curve very convenient.

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3.17
high-frequency average of the OVFL90
high-frequency average of the output vibratory force level for an input sound pressure level of
90 dB
3.18
full-on HFA-AMSL
full-on high-frequency average acousto-mechanical sensitivity level
HFA for an input SPL of 50 dB when the gain control of a bone conduction hearing aid is at its
full-on position
Note 1 to entry: The hearing aid shall be set to maximum possible gain setting. Where possible, the AGC function
of AGC hearing aids shall be set to have minimum effect for all measurements.
Note 2 to entry: The manufacturer shall specify the full-on settings used for measurements by providing either a
test program, a set of programmed settings or by reference to physical control settings.
Note 3 to entry: Other adaptive features, such as some directionality, noise suppression, and feedback
suppression systems etc., which may affect the validity of measurements made with steady-state pure-tone signals,
should be disabled. The settings used for measurements shall be specified by the manufacturer by providing either
a test program, a set of programmed settings or by reference to physical control settings.
3.19
RTS
reference test setting of the gain control
setting of the gain control required to produce, for an input SPL of 60 dB, an HFA-AMSL
within ±1,5 dB of the HFA-OVFL90 minus 77 dB, or, if the full-on HFA gain for an input
...