SIST EN 61669:2016

SLOVENSKI STANDARD
SIST EN 61669:2016
01-april-2016
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SIST EN 61669:2002
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Electroacoustics - Measurement of real-ear acoustical performance characteristics of
hearing aids
Ta slovenski standard je istoveten z: EN 61669:2016
ICS:
11.180.15 3ULSRPRþNL]DJOXKHRVHEHLQ Aids for deaf and hearing
RVHEH]RNYDURVOXKD impaired people
17.140.50 Elektroakustika Electroacoustics
SIST EN 61669:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 61669:2016

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SIST EN 61669:2016


EUROPEAN STANDARD EN 61669

NORME EUROPÉENNE

EUROPÄISCHE NORM
February 2016
ICS 17.140.50 Supersedes EN 61669:2001
English Version
Electroacoustics - Measurement of real-ear acoustical
performance characteristics of hearing aids
(IEC 61669:2015)
Électroacoustique - Mesure des caractéristiques de Elektroakustik - Messung der Kenndaten von Hörgeräten
performances acoustiques des appareils de correction am menschlichen Ohr
auditive sur une oreille réelle (IEC 61669:2015)
(IEC 61669:2015)
This European Standard was approved by CENELEC on 2015-12-09. 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, 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: Avenue Marnix 17, B-1000 Brussels
© 2016 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
 Ref. No. EN 61669:2016 E

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SIST EN 61669:2016
EN 61699:2016
European foreword
The text of document 29/886/FDIS, future edition 2 of IEC 61699, prepared by
IEC/TC 29 "Electroacoustics" was submitted to the IEC-CENELEC parallel vote and approved by
CENELEC as EN 61699:2016.

The following dates are fixed:
(dop) 2016-09-09
• latest date by which the document has to be
implemented at national level by
publication of an identical national
standard or by endorsement
(dow) 2018-12-09
• latest date by which the national
standards conflicting with the
document have to be withdrawn

This document supersedes EN 61699:2001.

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

Endorsement notice
The text of the International Standard IEC 61699:2015 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 60118-0 NOTE Harmonized as EN 60118-0.
IEC 60118-7 NOTE Harmonized as EN 60118-7.
IEC 60118-8 NOTE Harmonized as EN 60118-8.
IEC 60118-15 NOTE Harmonized as EN 60118-15.
IEC 60318-4 NOTE Harmonized as EN 60318-4.

2

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SIST EN 61669:2016
EN 61699:2016

Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
NOTE 1 When 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 60318-5 -  Electroacoustics - Simulators of human EN 60318-5 -
head and ear -- Part 5: 2 cm³ coupler for
the measurement of hearing aids and
earphones coupled to the ear by means of
ear inserts
IEC 60601-1 -  Medical electrical equipment -- Part 1: EN 60601-1 -
General requirements for basic safety and
essential performance
IEC 60601-1-2 -  Medical electrical equipment -- Part 1-2: EN 60601-1-2 -
General requirements for basic safety and
essential performance - Collateral
standard: Electromagnetic disturbances -
Requirements and tests
IEC 60942 -  Electroacoustics - Sound calibrators EN 60942 -
IEC 61260-1 -  Electroacoustics - Octave-band and EN 61260-1 -
fractional-octave-band filters -- Part 1:
Specifications
ISO 266 -  Acoustics - Preferred frequencies EN ISO 266 -
ISO 8253-2 -  Acoustics - Audiometric test methods - Part EN ISO 8253-2 -
2: Sound field audiometry with pure-tone
and narrow-band test signals
ISO/TR 25417 -  Acoustics_- Definitions of basic quantities - -
and terms

3

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SIST EN 61669:2016

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SIST EN 61669:2016



IEC 61669

®


Edition 2.0 2015-11




INTERNATIONAL



STANDARD




NORME



INTERNATIONALE











Electroacoustics – Measurement of real-ear acoustical performance

characteristics of hearing aids




Électroacoustique – Mesure des caractéristiques de performances acoustiques

des appareils de correction auditive sur une oreille réelle

















INTERNATIONAL

ELECTROTECHNICAL

COMMISSION


COMMISSION

ELECTROTECHNIQUE


INTERNATIONALE




ICS 17.140.50 ISBN 978-2-8322-2994-1



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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SIST EN 61669:2016
– 2 – IEC 61669:2015 © IEC 2015
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
1 Scope . 7
2 Normative references . 7
3 Terms and definitions . 8
4 Test setup diagrams . 13
5 Limitations . 15
6 Test equipment . 16
6.1 Safety requirements . 16
6.2 Ambient conditions. 16
6.3 Test signal . 16
6.4 Sound field source . 17
6.5 Coupled sound source . 17
6.6 Test signal range . 17
6.7 Test signal level indication . 17
6.8 Equalization . 17
6.9 Frequency . 17
6.10 Harmonic distortion . 17
6.11 Probe microphone measurement . 17
6.12 Noise floor of probe microphone measurement . 17
6.13 Attenuation of probe microphone to external signals . 18
6.14 Analysis characteristics. 18
6.15 Output indication . 18
6.16 Graphical printout . 18
7 Test conditions . 19
7.1 Ambient conditions in the test space . 19
7.2 Background noise . 19
7.3 Acoustical properties . 19
7.4 Sound field characteristics . 19
7.5 Calibration . 19
7.6 Equalization . 19
7.6.1 General . 19
7.6.2 Substitution method . 19
7.6.3 Modified pressure method – Stored equalization . 20
7.6.4 Modified pressure method – Concurrent equalization . 20
7.7 Test signal level . 20
7.8 Location of the subject . 20
7.9 Location of the tester . 20
7.10 Location of the field reference point . 20
7.11 Location of the measurement point . 21
7.12 Instructions to the subject . 21
7.13 Location and coupling of the hearing aid . 21
7.14 Operating conditions for the hearing aid . 21
8 Measurements . 21
8.1 General . 21

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SIST EN 61669:2016
IEC 61669:2015 © IEC 2015 – 3 –
8.2 Real-ear unaided response (REUR) curve. 21
8.3 Real-ear unaided gain (REUG) curve . 22
8.4 Real-ear occluded response (REOR) curve . 22
8.5 Real-ear occluded gain (REOG) curve . 22
8.6 Real-ear aided response (REAR) curve. 22
8.7 Real-ear aided gain (REAG) curve . 23
8.8 Real-ear insertion gain (REIG) curve . 23
8.9 Real-ear to coupler difference (RECD) curve . 23
8.10 Real-ear to dial difference (REDD) curve . 23
9 Measurement uncertainty for the performance requirements of Clause 6 . 24
Annex A (informative) Positioning the probe microphone sound inlet at the
measurement point . 25
A.1 General . 25
A.2 Visual positioning . 25
A.3 Acoustically-assisted positioning . 25
A.4 Acoustic positioning – Method 1 . 26
A.5 Acoustic positioning – Method 2 . 26
A.6 Geometrical positioning . 26
Annex B (informative) Issues in RECD measurement and application . 27
B.1 General . 27
B.2 Influence of the coupled sound source . 27
B.3 Estimating ear canal SPL produced by a hearing aid. 30
B.4 Correcting an HL audiogram obtained with an insert earphone and a
standard eartip . 32
B.5 Correcting an HL audiogram obtained with an insert earphone and a custom
earmould. 32
Annex C (informative) Relationship between tolerance interval, corresponding
acceptance interval and the maximum permitted uncertainty of measurement . 34
Bibliography . 35

Figure 1 – Test set-up . 14
Figure 2 – Real-ear measurement arrangement . 15
Figure B.1 – Computer-simulated ECLD for an average adult ear . 29
Figure B.2 – Computer-simulated ECLD for an average 3-month old child’s ear . 29
Figure B.3 – Computer-simulated error in estimating SPL in an average adult ear . 31
Figure B.4 – Computer-simulated error in estimating SPL in an average 3-month old
child’s ear . 31
Figure B.5 – Computer-simulated HL correction for an average 3 month old child’s ear . 33
Figure C.1 – Relationship between tolerance interval, corresponding acceptance
interval and the maximum permitted uncertainty of measurement . 34

Table 1 – Tolerance limits, acceptance limits and U for basic measurements . 24
max

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INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________

ELECTROACOUSTICS –
MEASUREMENT OF REAL-EAR ACOUSTICAL
PERFORMANCE CHARACTERISTICS OF 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 61669 has been prepared by IEC technical committee 29:
Electroacoustics.
This second edition cancels and replaces the first edition of IEC 61669:2001 and the first
edition of ISO 12124:2001. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to
IEC 61669:2001 and ISO 12124:2001:
a) the addition of the International Speech Test Signal as a preferred speech-like stimulus;
b) definitions and test methods for the real-ear to dial difference;
c) definitions and test methods for the real-ear to coupler difference and
d) an annex dealing with issues in the measurement and application of the real-ear to
coupler difference;

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SIST EN 61669:2016
IEC 61669:2015 © IEC 2015 – 5 –

The text of this standard is based on the following documents:
FDIS Report on voting
29/886/FDIS 29/893/RVD

Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
The committee has decided that the contents of this publication will remain unchanged until
the stability date indicated on the IEC website under "http://webstore.iec.ch" in the data
related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.

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SIST EN 61669:2016
– 6 – IEC 61669:2015 © IEC 2015
INTRODUCTION
The performance characteristics of hearing aids in actual use can differ significantly from
those determined in accordance with standards such as IEC 60118-0, and IEC 60118-7, due
to differing acoustic influence and coupling presented by individual ears. Measuring methods
that take into account the acoustic coupling and the acoustic influence of the individual
wearer on the performance of hearing aids are therefore important in the fitting of these
devices. Such measuring methods have come to be known as “real-ear measurements” and
are sometimes performed clinically in less than ideal acoustic environments. The accuracy
and repeatability of measurements made under such conditions are complex functions of the
sound field, the test environment, the nature of the test signal, the hearing aid under
evaluation, the method of test signal control, the location of the sound field source, the nature
of the data acquisition, analysis and presentation as well as the degree of subject movement
permitted.
This standard provides definitions for terms used in the measurement of real-ear performance
characteristics of hearing aids, provides procedural and reporting guidelines, and identifies
essential characteristics to be reported by the manufacturer of equipment used for this
purpose. Acceptable tolerances for the control and measurement of sound pressure levels
are indicated. Where possible, sources of error have been identified and suggestions provided
for their management.

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SIST EN 61669:2016
IEC 61669:2015 © IEC 2015 – 7 –
ELECTROACOUSTICS –
MEASUREMENT OF REAL-EAR ACOUSTICAL
PERFORMANCE CHARACTERISTICS OF HEARING AIDS



1 Scope
This International Standard gives recommendations and requirements for the measurement
and estimation of the real-ear acoustical performance characteristics of air-conduction
hearing aids and for the measurement of certain acoustic properties of the ear related to the
application of hearing aids.
Measurements of real-ear acoustical characteristics of hearing aids which apply non-linear or
analytical processing techniques are valid only for the test signals used and conditions
employed.
The purpose of this standard is to ensure that measurements of real-ear acoustical
performance characteristics of a given hearing aid on a given human ear can be replicated in
other locations with other test equipment.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and
are indispensable for its application. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any
amendments) applies.
IEC 60601-1, Medical electrical equipment – Part 1: General requirements for basic safety
and essential performance
IEC 60601-1-2, Medical electrical equipment – Part 1-2: General requirements for basic safety
and essential performance – Collateral Standard: Electromagnetic disturbances –
Requirements and tests
3
IEC 60318-5, Electroacoustics – Simulators of human head and ear – Part 5: 2 cm coupler
for the measurement of hearing aids and earphones coupled to the ear by means of ear
inserts
IEC 60942, Electroacoustics – Sound calibrators
IEC 61260-1, Electroacoustics – Octave-band and fractional-octave-band filters – Part 1:
Specifications
ISO 266, Acoustics – Preferred frequencies
ISO 8253-2, Acoustics – Audiometric test methods – Part 2: Sound field audiometry with pure-
tone and narrow-band test signals
ISO/TR 25417, Acoustics – Definitions of basic quantities and terms

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SIST EN 61669:2016
– 8 – IEC 61669:2015 © IEC 2015
3 Terms and definitions
For the purpose of this document, the terms and definitions of ISO/TR 25417 and the
following apply:
3.1
test signal
acoustic signal at the field reference point
3.2
coupled sound source
earphone or hearing aid receiver and any tubing used to couple its acoustic output, without
leakage, to the ear canal or the cavity of a coupler
3.3
free sound field
sound field where the boundaries of the room exert a negligible effect on the sound waves
Note 1 to entry: In practice, a free sound field is a field in which the influence of reflections at the boundaries or
other disturbing objects is negligible over the frequency range of interest.
[SOURCE: ISO 8253-2:2009, 3.12, modified (addition of note to entry)]
3.4
quasi-free sound field
sound field where the boundaries of the room exert only a moderate effect on the sound
waves
[SOURCE: ISO 8253-2:2009, 3.13]
3.5
subject
person in whose ear the hearing aid performance is characterized
3.6
subject reference point
point bisecting the line joining the centres of the openings of the ear canals of the subject (at
the junction between concha and ear canal)
Note 1 to entry: In cases where severe head shape abnormality or asymmetry make it difficult to determine the
reference point of the subject, the subject reference point used should be stated.
3.7
subject test position
position with subject seated in a reproducible upright position with the head erect and the
subject reference point located on the test axis at the working distance
3.8
test axis
line through the centre of the surface from which sound exits the sound field source and in the
direction of maximum acoustic radiation
SEE: Figure 1.
3.9
test point
reproducible position on the test axis at which the subject reference point is located for test
purposes

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SIST EN 61669:2016
IEC 61669:2015 © IEC 2015 – 9 –
SEE: Figure 1.
3.10
working distance
distance from the subject reference point to the plane of the mounting ring or protective grille
of the sound field source measured along the test axis
SEE: Figure 1.
3.11
SPL
sound pressure level
ten times the logarithm to the base 10 of the ratio of the square of the sound pressure, p, to
the square of a reference value, p
0
2 2
L = 10lg(p /p ) dB
p 0
where the reference value, p , is 20 µPa
0
Note 1 to entry: Sound pressure level is expressed in decibels.
2
Note 2 to entry: Because of practical limitations of the measuring instruments, p is always understood to denote
the square of a frequency-weighted, frequency-band-limited or time-weighted sound pressure.
Note 3 to entry: This note applies to the French version only.
[SOURCE: ISO/TR 25417:2007, 1.2]
3.12
BSPL
band sound pressure level
SPL for a specified frequency band
Note 1 to entry: This note applies to the French language only.
3.13
test signal level
SPL of the test signal at the field reference point
Note 1 to entry: For broad-band signals the bandwidth of the SPL measurement and the BSPL as a function of
frequency should be specified and stated.
3.14
equalization
process of controlling the test signal level as a function of frequency such that it does not vary
from the desired level
3.14.1
concurrent equalization
real time equalization
equalization performed at the time of measurement based on the monitoring of the test signal
level
3.14.2
stored equalization
equalization performed at the time of measurement based on data recorded during a prior
measurement of the sound field

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...