WG 13 - TC 29/WG 13

IEC 61669:2015 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. 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.

IEC 60118-0:2022 gives recommendations for the measurement of the performance characteristics of air conduction hearing aids measured with an acoustic coupler or occluded ear simulator.
This document is applicable to the measurement and evaluation of the electroacoustical characteristics of hearing aids, for example for type testing and manufacturer data sheets.
This document is also applicable for the measurement of the performance characteristics of hearing aids for production, supply and delivery quality-assurance purposes.
The measurement results obtained by the methods specified in this document will express the performance under conditions of the measurement and can deviate substantially from the performance of the hearing aid under actual conditions of use.
This document primarily uses an acoustic coupler according to IEC 60318-5 which is only intended for loading a hearing aid with specified acoustic impedance and is not intended to reproduce the sound pressure in a person's ear. For measurements reflecting the output level in the normal human ear the occluded ear simulator according to IEC 60318-4 can be used. For extended high-frequency measurements and for deep insert hearing aids, the acoustic coupler according to IEC 60318-8 can be used.
This document also covers measurement of hearing aids with non-acoustic inputs, such as wireless, inductive or electrical input.
This document does not cover the measurement of hearing aids for simulated in situ working conditions, for which IEC 60118-8 can be applied.
This document does not cover the measurement of hearing aids under typical user settings and using a speech-like signal, for which IEC 60118-15 can be applied.
IEC 60118-0:2022 merges and updates the methods previously described in IEC 60118-0:2015 and IEC 60118-7:2005. It cancels and replaces the third edition of IEC 60118-0 published in 2015. This edition constitutes a technical revision.
Measurements for quality control as described in IEC 60118-7:2005 can be found in Clause 10 of this document.
This edition includes the following significant technical changes with respect to previous editions:
a) the default use of an acoustic coupler according to IEC 60318-5,
b) addition of the optional use of an occluded ear simulator according to IEC 60318-4,
c) addition of the optional use of an acoustic coupler according to IEC 60318-8 (new standard based on IEC TS 62886) when information about the response above 8 kHz is needed, or the optional use of the acoustic coupler according to IEC 60318-8 for deep insert hearing aids,
d) the addition of measurements of the performance of hearing aids for production, supply and delivery quality assurance purposes,
e) corrected and updated measurement configuration and methods, adding the use of a sequential measurement as preferred configuration,
f) updated and expanded measurement procedures for the non-acoustic inputs of the hearing aid.

IEC 60118-16:2022 gives definitions for common hearing aid features such as noise reduction or feedback reduction, etc. Only acoustical inputs are considered. Binaural features are currently not covered in this document. In addition, measurement procedures are described to verify hearing aid features. The objective is not to evaluate the performance of features but to verify their existence and functionality.
Furthermore, definitions and procedures are kept as general as possible so that this document can be applied to various types of hearing aids, for example, air-conduction hearing aids or bone conduction hearing aids. To this end, the general definition for the term "hearing aid" given in IEC 60118-0 is adopted, and this document does not refer to any specific ear simulator or acoustic coupler but uses a general definition of a coupler. However, if a general view is not applicable or leads to unclear or complex wording, the situation for an air-conduction hearing aid only is considered. Nevertheless, an explanation is given on how this document can be applied to hearing aids which do not use air conduction.

IEC 60118-13:2019 covers the relevant EMC phenomena for hearing aids. Hearing aid immunity to high frequency fields originating from digital wireless devices such as mobile phones was identified as one of the most relevant EMC phenomena impacting hearing aids.
IEC 60118-13:2019 cancels and replaces the fourth edition published in 2016 and constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) it introduces a new measurement method and set of EMC requirements for hearing aids immunity to mobile digital wireless devices;
b) generic EMC requirements for hearing aids are no longer included – should be covered by other standards as appropriate.

IEC TR 62809:2019 provides an overview of the requirements and tests of IEC 60601-2-66 in combination with the applicable sections of IEC 60601-1, and the collateral standards of the IEC 60601 series. It is intended to assist various groups involved in the product lifecycles process - like designers and suppliers - to get an overview of the basic requirements without studying all involved standard documents in detail. The table includes not all but just the more common requirements and tests. It is crucial to understand that the summary in this document cannot serve as an input for a product requirement specification or as a test plan without consulting IEC 60601-2-66 itself. This document alone cannot be used to establish or assess compliance to IEC 60601-2-66.

IEC 60601-2-66:2019 applies to the BASIC SAFETY of HEARING AIDS and HEARING AID SYSTEMS, hereafter also referred to as ME EQUIPMENT or ME SYSTEM. IEC 60601-2-66:2019 cancels and replaces the second edition published in 2015. It constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition:
a) revision of the definition about ESSENTIAL PERFORMANCE;
b) revision of the application of IEC 60601-1-2:2014 for electromagnetic disturbances;
c) correction of the used voltage for HEARING AIDS from 1,6 V to 4,5 V;
d) correction of the drop test level from 1,5 m to 1,0 m;
e) correction of the wording of IEC 60601-2-66:2015.

IEC 60118-9:2019 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.
IEC 60118-9:2019 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.

IEC 60118-13:2016 covers relevant EMC phenomena for hearing aids. Hearing aid immunity to high frequency fields originating from digital wireless devices such as mobile phones was originally identified as the most relevant EMC phenomena impacting hearing aids. Since the inclusion of RF generating components within hearing aids, such as digital signal processors or wireless transceivers, additional EMC compliance requirements apply. The EMC requirements now included are radiated emissions and immunity to electrostatic discharge, power frequency magnetic fields, and radiated RF electromagnetic fields. Requirements associated with connected power and signal lines are not included. This fourth edition cancels and replaces the third edition published in 2011 and constitutes a technical revision.

IEC 60601-2-66:2015 applies to the basic safety of hearing instruments and hearing instrument systems, hereafter also referred to as ME equipment or ME system. This second edition cancels and replaces the first edition published in 2012. It constitutes a technical revision to adapt IEC 60601-2-66:2012 to the technical corrections introduced by Amendment 1 (2012) to IEC 60601-1:2005, as well as to clarify and correct the wording of this particular standard and to implement minor changes requested by interested parties.

IEC 60118-0:2015 gives recommendations for the measurement of the performance characteristics of air conduction hearing aids based on a free field technique and measured with an acoustic coupler. This third edition cancels and replaces the second edition published in 1983 and its Amendment 1:1994 as well as IEC 60118-1:1995, Amendment 1:1998, IEC 60118-2:1983, Amendment 1:1993, Amendment 2:1997 and IEC 60118-6:1999. This edition constitutes a technical revision.

IEC/TR 62809:2013(E) provides an overview of the requirements and tests of IEC 60601-2-66 in combination with the applicable sections of IEC 60601-1, and the collateral standards of the IEC 60601 series. It is intended to assist various groups involved in the product lifecycles process - like designers and suppliers - to get an overview of the basic requirements without studying all involved standard documents in detail. The table includes not all but just the more common requirements and tests. During the preparation of IEC 60601-2-66, members of the involved technical committee and working group voiced concerns about the complexity of the document and its structure as part of the IEC 60601 series. There was also concern that groups in the hearing instrument community would have problems to understand and apply the standard and that this could be an issue with its acceptability. In order to have a broad consensus for the new standard it was agreed that the standard should be supported by this Technical Report, which should enable members of the community and the industry to have a basic understanding of the requirements of the standard, without the need to study the complete standard document and the documents that are referenced in it. It is crucial to understand that the summary in this document cannot serve as an input for a product requirement specification or as a test plan without consulting the standard document itself. This Technical Report alone cannot be used to establish or assess compliance to the standard. Keywords: hearing instruments, hearing aids, hearing

IEC 60601-2-66:2012 International Standard applies to the basic safety of hearing instruments and hearing instrument systems. Hazards inherent in the intended physiological function of hearing instruments or hearing instrument systems within the scope of this standard are not covered by specific requirements in this standard except in 201.7.9.2 and 201.9.6. Accessories to hearing instruments in the home healthcare environment (e.g. remote control units, audio streamers, battery chargers, power supplies) are covered by the most applicable standard, IEC 60065, IEC 60950-1 or other applicable IEC safety standards. Accessories connected to a hearing instrument may form a hearing instrument system. Only the hearing instrument and its detachable parts are subject to all applicable clauses of this particular standard. The remaining components of the hearing instrument system are subject to requirements of this particular standard that result from their connection to the hearing instrument system. This standard does not apply to:
- cochlear implants or other implanted hearing instruments;
- bone conduction hearing instruments;
- educational hearing instruments (i.e. group hearing instruments, auditory trainers etc.);
- the application of a hearing instrument for the measurement of hearing levels. IEC 60645-1 applies;
- audio-frequency induction-loop systems or their component parts, as described in IEC 60118-4 and IEC 62489-1;
- assisted hearing instrument systems using infra-red or radio;
- and the sound generating function of a tinnitus masker.

IEC 60118-15:2012 specifies a test signal designed to represent normal speech, the International Speech Test Signal (ISTS), together with the procedures and the requirements for measuring the characteristics of signal processing in air-conduction hearing aids. The measurements are used to derive the estimated insertion gain (EIG). For the purposes of characterizing a hearing aid for production, supply and delivery, the procedures and requirements to derive the coupler gain on a 2 cm3 coupler as defined in IEC 60318-5 are also specified. The purpose of this standard is to ensure that the same measurements made on a hearing aid following the procedures described, and using equipment complying with these requirements, give substantially the same results. Measurement methods that take into account the acoustic coupling of a hearing aid to the individual ear and the acoustic influence of the individual anatomical variations of an end-user on the acoustical performance of the hearing aid, known as real-ear measurements, are outside the scope of this particular standard.

IEC 60118-13:2011 in principle covers all relevant EMC phenomena for hearing aids. Hearing aid immunity to high frequency electromagnetic fields originating from digital wireless devices operating in the frequency ranges 0,8 GHz to 0,96 GHz and 1,4 GHz to 2,48 GHz is currently identified as the only relevant EMC phenomenon regarding hearing aids. Future editions of this part of IEC 60118 may add tests for other frequency bands, as they come into more common use. IEC 61000-4-3 is the basis for relevant EMC tests to be conducted on hearing aids. Measurement methods and acceptance levels are described in this part of IEC 60118. This third edition cancels and replaces the second edition published in 2004 and constitutes a technical revision. It introduces a new set of requirements for use of hearing aids with mobile phones.

Describes methods for a test which simulates the acoustical effects of a median adult wearer on the performance of a hearing aid. Establishes certain guidelines for simulated in situ measurements of hearing aids; it describes a simplified method for simulated in situ measurements of hearing aids and a description for determination of the directivity index (DI) of directional microphones in hearing aids in the horizontal plane. In addition this second edition now specifies tolerances. Conformance to the specifications in this International Standard is demonstrated only when the result of a measurement, extended by the actual expanded uncertainty of measurement of the testing laboratory, lies fully within the tolerances specified in this International Standard extended by the values for Umax

Covers all relevant EMC phenomena for hearing aids. EMC phenomena, such as RF emission and electrostatic discharge, are not currently known to be a significant problem in connection with hearing aids and are therefore not dealt with. Based on new knowledge, they could be considered in connection with future revisions or extensions of this standard. Hearing aid immunity to high frequency electromagnetic fields originating from wireless telephone systems is currently identified as the only relevant EMC phenomena regarding hearing aids. IEC 61000-4-3 is the basis for relevant EMC tests to be conducted on hearing aids. Measurement methods and acceptance levels are described in this standard. For the purpose of this part of IEC 60118, two immunity classes of hearing aids are defined related to their use. "Bystander compatible" is defined as a situation, which ensures that a hearing aid is usable in environments where digital wireless devices are in operation in the proximity of the hearing aid wearer. "User compatible" hearing aids will ensure that a hearing aid is usable when the hearing aid wearer is using a digital wireless device at the wearer´s own aided ear. Measurement methods for hearing aids with non-acoustic outputs and for hearing aids connected to other equipment by cables are not given in this standard.

Specifies the method which is essentially the same as that described in CISPR publication 11, sub-clause 5.2.2. With this method, emphasis has been laid on simplicity and reproducibility, rather than on rigorous scientific method. lt has been purposely developed for use in an ordinary laboratory room to avoid the use of an expensive anechoic room. The method is intended for type tests but it may be used for acceptance tests and factory tests. The standard should be used in conjunction with IEC 60244-6.

Covers all relevant EMC phenomena for hearing aids. Specifies measurement methods and acceptance levels for hearing aid immunity to high frequency electromagnetic fields originating from digital telephone systems as specified in IEC 61000-4-3.

Applies to plugs and connector systems for hearing aids and specifies the dimensions and their tolerances for ensuring interchangeability.

Gives recommendations for the measurement of the performance characteristics of air-conduction hearing aids of a particular model for production, supply and delivery quality assurance purposes. The manufacturer will normally assign nominal values.

Specifies the electrical and safety characteristics of a circuit for an external electrical input to a personal hearing aid in order to ensure compatibility with external electrical or electroacoustic signal sources. In this standard, the hearing aid may include an adaptor (audio shoe) which incorporates connector systems described in IEC 60118-12.

Specifies a method of determining the electroacoustic performance of hearing aids fitted with an induction pick-up coil and used in an audio-frequency magnetic field. The induction pick-up performance is measured in a loop simulating conditions of use in room applications.

Refers to the ITU Radio Regulations and to the Recommendations and Reports of the CCIR.

Adds a new clause 10 to IEC 60118-2 second edition : Frequency response of hearing heads with AGC circuits in operation using steady-state broad-band signals.