EN 61669-2016 en Electroacoustics - Measurement of real-ear acoustical performance characteristics of hearing aids.pdf

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1、BSI Standards PublicationElectroacoustics Measurement of real-ear acoustical performance characteristics of hearing aidsBS EN 61669:2016National forewordThis British Standard is the UK implementation of EN 61669:2016.It is identical to IEC 61669:2015. It supersedes BS ISO 12124:2001and BS EN 61669:2

2、001 which are withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee EPL/29, Electroacoustics.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisions ofa

3、contract. Users are responsible for its correct application. The British Standards Institution 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 82916 1ICS 17.140.50Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the

4、authority of theStandards Policy and Strategy Committee on 29 February 2016.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN 61669:2016EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 61669February 2016 ICS 17.140.50 Supersedes EN 61669:2001 English Version E

5、lectroacoustics - Measurement of real-ear acoustical performance characteristics of hearing aids (IEC 61669:2015)lectroacoustique - Mesure des caractristiques de performances acoustiques des appareils de correction auditive sur une oreille relle (IEC 61669:2015)Elektroakustik - Messung der Kenndaten

6、 von Hrgerten am menschlichen Ohr (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 an

7、y 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 la

8、nguage 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, t

9、he 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 Uni

10、ted Kingdom. European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr 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

11、reserved worldwide for CENELEC Members. Ref. No. EN 61669:2016 E BS EN 61669:2016EN 61699:2016 2 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 61

12、699:2016. The following dates are fixed: latest date by which the document has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2016-09-09 latest date by which the national standards conflicting with the document have to be withdrawn (dow)

13、2018-12-09 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

14、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 601

15、18-7. 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. BS EN 61669:2016EN 61699:2016 3 Annex ZA (normative) Normative references to international publications with their corresponding European publications The followin

16、g 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 Inte

17、rnational 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 - Elec

18、troacoustics - 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 EN 60318-5 - IEC 60601-1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance EN 606

19、01-1 - 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 EN 60601-1-2 - IEC 60942 - Electroacoustics - Sound calibrators EN 60942 - IEC 61260-1 - Electr

20、oacoustics - Octave-band and fractional-octave-band filters - Part 1: Specifications EN 61260-1 - ISO 266 - Acoustics - Preferred frequencies EN ISO 266 - ISO 8253-2 - Acoustics - Audiometric test methods - Part 2: Sound field audiometry with pure-tone and narrow-band test signals EN ISO 8253-2 - IS

21、O/TR 25417 - Acoustics_- Definitions of basic quantities and terms - - BS EN 61669:2016 2 IEC 61669:2015 IEC 2015 CONTENTS FOREWORD. 4INTRODUCTION . 6 1 Scope 72 Normative references 7 3 Terms and definitions 84 Test setup diagrams 13 5 Limitations.156 Test equipment 16 6.1 Safety requirements166.2

22、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 indication176.8 Equalization 17 6.9 Frequency . 17 6.10 Harmonic distortion . 17 6.11 Probe microphone measurement . 17 6.12 Noise floor of probe microphone m

23、easurement . 17 6.13 Attenuation of probe microphone to external signals .186.14 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 f

24、ield characteristics 19 7.5 Calibration 19 7.6 Equalization197.6.1 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 subject207.9 Location of the t

25、ester 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 aid218 Measurements . 21 8.1 General . 21 BS EN 61669:2016IEC 61669:20

26、15 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 inserti

27、on 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

28、 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 couple

29、d 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 t

30、olerance 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 fo

31、r an average 3-month old childs 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 childs ear . 31 Figure B.5 Computer-simulated HL correction for an average 3 month old childs ear .

32、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 Umaxfor basic measurements . 24 BS EN 61669:2016 4 IEC 61669:2015 IEC 2015 INTERNATIONAL ELECTROTECHNICAL

33、 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).

34、 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 Spe

35、cifications (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 organizatio

36、ns 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

37、 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 C

38、ommittees 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 Na

39、tional 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 do

40、es 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 h

41、ave 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 what

42、soever, 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 public

43、ations 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 Stan

44、dard 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 techn

45、ical 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

46、 d) an annex dealing with issues in the measurement and application of the real-ear to coupler difference; BS EN 61669:2016IEC 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 appr

47、oval 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 th

48、e 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. BS EN 61669:2016 6 IEC 61669:2015 IEC 2015 INTRODUCTION The performance characteristics of hearing aid

49、s 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 “