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.

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This document is a supplement to ISO 21388 which applies to hearing aid fitting management (HAFM) services offered by hearing aid professionals (HAP). It focusses on tele-services which can substitute, or complement services defined in ISO 21388, and it defines services which is provided in the facilities of the HAP.
Moreover, this document specifies important preconditions such as education, facilities and systems that are required to ensure proper tele-services. If not other stated all definitions and requirements of ISO 21388 also apply for this document without further notice. Furthermore, it is tried to keep the structure of ISO 21388 to make it easier to use both standards together. It is recognized that certain populations with hearing loss such as children, persons with other disabilities or persons with implantable devices can require services outside the scope of this document.
Assisted tele-services provided by non-hearing aid professionals, self-fitting, and other non-hearing care related services are also outside the scope of this document.

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This document is a supplement to ISO 21388 which applies to hearing aid fitting management (HAFM) services offered by hearing aid professionals (HAP). It focusses on tele-services which can substitute, or complement services defined in ISO 21388, and it defines services which is provided in the facilities of the HAP.
Moreover, this document specifies important preconditions such as education, facilities and systems that are required to ensure proper tele-services. If not other stated all definitions and requirements of ISO 21388 also apply for this document without further notice. Furthermore, it is tried to keep the structure of ISO 21388 to make it easier to use both standards together. It is recognized that certain populations with hearing loss such as children, persons with other disabilities or persons with implantable devices can require services outside the scope of this document.
Assisted tele-services provided by non-hearing aid professionals, self-fitting, and other non-hearing care related services are also outside the scope of this document.

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This document is a supplement to ISO 21388 which applies to hearing aid fitting management (HAFM) services offered by hearing aid professionals (HAP). It focusses on tele-services which can substitute, or complement services defined in ISO 21388, and it defines services which is provided in the facilities of the HAP. Moreover, this document specifies important preconditions such as education, facilities and systems that are required to ensure proper tele-services. If not other stated all definitions and requirements of ISO 21388 also apply for this document without further notice. Furthermore, it is tried to keep the structure of ISO 21388 to make it easier to use both standards together. It is recognized that certain populations with hearing loss such as children, persons with other disabilities or persons with implantable devices can require services outside the scope of this document. Assisted tele-services provided by non-hearing aid professionals, self-fitting, and other non-hearing care related services are also outside the scope of this document.

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IEC 60601-2-66:2019 is available as IEC 60601-2-66:2019 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.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.

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This part of IEC 60118 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, e.g. air conduction hearing aids or bone conduction hearing aids. To this end, the general definition for hearing aid of IEC 60118-0:2015 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 is considered, only. Nevertheless, in Clause 4, an explanation is given on how this document can be applied to hearing aids which do not use air conduction.

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This document applies to hearing aid fitting management (HAFM) services offered by hearing aid professionals (HAP) when providing benefit for their clients. The provision of hearing aids relies on the knowledge and practices of a hearing aid professional, to ensure the proper fitting and adequate service in the interest of the client with hearing loss.
This document specifies general processes of HAFM from the client profile to the follow-up through administering, organising and controlling hearing aid fitting through all stages. It also specifies important preconditions such as education, facilities and systems that are required to ensure proper services.
The focus of this document is the services offered to the majority of adult clients with hearing impairment. It is recognized that certain populations with hearing loss such as children, persons with other disabilities or persons with implantable devices can require services outside the scope of this document. This document generally applies to air conduction hearing aids and for the most part also to bone conduction devices.
Hearing loss can be a consequence of serious medical conditions. Hearing aid professionals are not in a position to diagnose or treat such conditions. When assisting clients seeking hearing rehabilitation without prior medical examination, hearing aid professionals are expected to be observant of symptoms of such conditions and refer to proper medical care.
Further to the main body of the document, which specifies the HAFM requirements and processes, several informative annexes are provided. Appropriate education of hearing aid professionals is vital for exercising HAFM. Annex A defines the competencies required for the HAFM processes. Annex B offers a recommended curriculum for the education of hearing aid professionals. Annex C is an example of an appropriate fitting room. Annex D gives guidance on the referral of clients for medical or other specialist examination and treatment. Annex E is a recommendation for important information to be exchanged with the client during the process of HAFM. Annex F is a comprehensive terminology list offering definitions of the most current terms related to HAFM.
It is the intention that these annexes be helpful to those who wish to deliver HAFM of the highest quality.

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This document applies to hearing aid fitting management (HAFM) services offered by hearing aid professionals (HAP) when providing benefit for their clients. The provision of hearing aids relies on the knowledge and practices of a hearing aid professional, to ensure the proper fitting and adequate service in the interest of the client with hearing loss.
This document specifies general processes of HAFM from the client profile to the follow-up through administering, organising and controlling hearing aid fitting through all stages. It also specifies important preconditions such as education, facilities and systems that are required to ensure proper services.
The focus of this document is the services offered to the majority of adult clients with hearing impairment. It is recognized that certain populations with hearing loss such as children, persons with other disabilities or persons with implantable devices can require services outside the scope of this document. This document generally applies to air conduction hearing aids and for the most part also to bone conduction devices.
Hearing loss can be a consequence of serious medical conditions. Hearing aid professionals are not in a position to diagnose or treat such conditions. When assisting clients seeking hearing rehabilitation without prior medical examination, hearing aid professionals are expected to be observant of symptoms of such conditions and refer to proper medical care.
Further to the main body of the document, which specifies the HAFM requirements and processes, several informative annexes are provided. Appropriate education of hearing aid professionals is vital for exercising HAFM. Annex A defines the competencies required for the HAFM processes. Annex B offers a recommended curriculum for the education of hearing aid professionals. Annex C is an example of an appropriate fitting room. Annex D gives guidance on the referral of clients for medical or other specialist examination and treatment. Annex E is a recommendation for important information to be exchanged with the client during the process of HAFM. Annex F is a comprehensive terminology list offering definitions of the most current terms related to HAFM.
It is the intention that these annexes be helpful to those who wish to deliver HAFM of the highest quality.

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The present document specifies technical characteristics and methods of measurements for audio frequency induction
loop drivers operating from 10 Hz to 9 kHz used in Audio Frequency Induction Loop System (AFILS) with an upper
limit of 45 Arms.
NOTE 1: The object of an AFILS is to transmit an audio signal to people with hearing difficulties. The receiver in
this case is normally a hearing aid or cochlear implant with a built in telecoil, both of which are covered
by ETSI EN 300 422-4 [i.11].
These radio equipment types are capable of operating in the frequency band within the 10 Hz to 9 kHz range:
• with (an) output connection(s);
• for audio frequency baseband transmission (un-modulated and without the use of a carrier).
The present document covers induction loop drivers with output connectors. Integral antenna systems are covered by
ETSI EN 300 422-4 [i.11].
NOTE 2: The relationship between the present document and essential requirements of article 3.2 of Directive
2014/53/EU [i.1] is given in annex A.

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This document specifies ergonomic requirements and recommendations for consumer product spoken instructions that are provided to guide users in the operation of a product and/or as a means of providing feedback to users about the status/state of a product. Such instructions can be used by persons with or without visual impairments, and are useful for users who have difficulty reading and/or cognitive impairments.
The applicability of the requirements and recommendations described in this document does not depend on the language of the instructions or whether the instructions are provided via recorded human speech or synthesized speech from text.
The requirements and recommendations in this document are applicable to conventional, stand-alone consumer products in general, whose function is limited by characteristics that prevent a user from attaching, installing or using assistive technology in order to use the product. They are not applicable to machines and equipment used for professional work.
This document does not apply to products for which the instructional content and/or the means of presentation are specified in other standards (e.g. medical devices, fire alarms). It also does not provide recommendations or requirements for spoken instructions of Interactive Voice Response (IVR) systems or digital assistants on personal computers or similar devices.
NOTE    ISO 9241‑154 provides recommendations or requirements for IVR systems.
This document does not specify voice sounds of text-to-speech systems or narrative speech used in place of printed instruction manuals and independently from the product.

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This document specifies design requirements and recommendations for indicator lights, mainly LED sourced, on consumer products for use by older people and people with visual disabilities. It does not consider the needs of persons who are blind.
Indicator lights include those that inform users visually about the conditions, changes in functional status and settings, and malfunction of products. They convey information by light on/off, time-modulated intensity, blinking, colour, luminance level, and layout.
This document addresses household and home appliances. It excludes electronic displays presenting characters and graphics, machinery, and appliances in special use for professional, technical, and industrial applications.

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IEC 60601-2-66:2019 is available as IEC 60601-2-66:2019 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.

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.

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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.

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This document specifies design requirements and recommendations for indicator lights, mainly LED sourced, on consumer products for use by older people and people with visual disabilities. It does not consider the needs of persons who are blind.
Indicator lights include those that inform users visually about the conditions, changes in functional status and settings, and malfunction of products. They convey information by light on/off, time-modulated intensity, blinking, colour, luminance level, and layout.
This document addresses household and home appliances. It excludes electronic displays presenting characters and graphics, machinery, and appliances in special use for professional, technical, and industrial applications.

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This document specifies ergonomic requirements and recommendations for consumer product spoken instructions that are provided to guide users in the operation of a product and/or as a means of providing feedback to users about the status/state of a product. Such instructions can be used by persons with or without visual impairments, and are useful for users who have difficulty reading and/or cognitive impairments.
The applicability of the requirements and recommendations described in this document does not depend on the language of the instructions or whether the instructions are provided via recorded human speech or synthesized speech from text.
The requirements and recommendations in this document are applicable to conventional, stand-alone consumer products in general, whose function is limited by characteristics that prevent a user from attaching, installing or using assistive technology in order to use the product. They are not applicable to machines and equipment used for professional work.
This document does not apply to products for which the instructional content and/or the means of presentation are specified in other standards (e.g. medical devices, fire alarms). It also does not provide recommendations or requirements for spoken instructions of Interactive Voice Response (IVR) systems or digital assistants on personal computers or similar devices.
NOTE    ISO 9241‑154 provides recommendations or requirements for IVR systems.
This document does not specify voice sounds of text-to-speech systems or narrative speech used in place of printed instruction manuals and independently from the product.

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This document applies to hearing aid fitting management (HAFM) services offered by hearing aid professionals (HAP) when providing benefit for their clients. The provision of hearing aids relies on the knowledge and practices of a hearing aid professional, to ensure the proper fitting and adequate service in the interest of the client with hearing loss. This document specifies general processes of HAFM from the client profile to the follow-up through administering, organising and controlling hearing aid fitting through all stages. It also specifies important preconditions such as education, facilities and systems that are required to ensure proper services. The focus of this document is the services offered to the majority of adult clients with hearing impairment. It is recognized that certain populations with hearing loss such as children, persons with other disabilities or persons with implantable devices can require services outside the scope of this document. This document generally applies to air conduction hearing aids and for the most part also to bone conduction devices. Hearing loss can be a consequence of serious medical conditions. Hearing aid professionals are not in a position to diagnose or treat such conditions. When assisting clients seeking hearing rehabilitation without prior medical examination, hearing aid professionals are expected to be observant of symptoms of such conditions and refer to proper medical care. Further to the main body of the document, which specifies the HAFM requirements and processes, several informative annexes are provided. Appropriate education of hearing aid professionals is vital for exercising HAFM. Annex A defines the competencies required for the HAFM processes. Annex B offers a recommended curriculum for the education of hearing aid professionals. Annex C is an example of an appropriate fitting room. Annex D gives guidance on the referral of clients for medical or other specialist examination and treatment. Annex E is a recommendation for important information to be exchanged with the client during the process of HAFM. Annex F is a comprehensive terminology list offering definitions of the most current terms related to HAFM. It is the intention that these annexes be helpful to those who wish to deliver HAFM of the highest quality.

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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.

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This document specifies design requirements and recommendations for indicator lights, mainly LED sourced, on consumer products for use by older people and people with visual disabilities. It does not consider the needs of persons who are blind. Indicator lights include those that inform users visually about the conditions, changes in functional status and settings, and malfunction of products. They convey information by light on/off, time-modulated intensity, blinking, colour, luminance level, and layout. This document addresses household and home appliances. It excludes electronic displays presenting characters and graphics, machinery, and appliances in special use for professional, technical, and industrial applications.

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This document specifies ergonomic requirements and recommendations for consumer product spoken instructions that are provided to guide users in the operation of a product and/or as a means of providing feedback to users about the status/state of a product. Such instructions can be used by persons with or without visual impairments, and are useful for users who have difficulty reading and/or cognitive impairments. The applicability of the requirements and recommendations described in this document does not depend on the language of the instructions or whether the instructions are provided via recorded human speech or synthesized speech from text. The requirements and recommendations in this document are applicable to conventional, stand-alone consumer products in general, whose function is limited by characteristics that prevent a user from attaching, installing or using assistive technology in order to use the product. They are not applicable to machines and equipment used for professional work. This document does not apply to products for which the instructional content and/or the means of presentation are specified in other standards (e.g. medical devices, fire alarms). It also does not provide recommendations or requirements for spoken instructions of Interactive Voice Response (IVR) systems or digital assistants on personal computers or similar devices. NOTE ISO 9241‑154 provides recommendations or requirements for IVR systems. This document does not specify voice sounds of text-to-speech systems or narrative speech used in place of printed instruction manuals and independently from the product.

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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.

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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.

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The present document specifies technical characteristics and methods of measurements for audio frequency induction
loop amplifiers and receivers operating from 10 Hz to 9 kHz used in audio frequency induction loop systems (AFILS).
NOTE: The object of an AFILS is to transmit an audio signal to people with hearing difficulties. The receiver in
this case is normally a hearing aid with a built in telecoil.
These radio equipment types are capable of operating in the frequency band within the 10 Hz to 9 kHz range:
• either with an output connection(s) and dedicated loop(s) or with an internal loop(s);
• for audio frequency baseband transmission (un-modulated and without the use of a carrier).
The present document covers fixed induction loop amplifiers, mobile induction loop amplifiers and portable induction
loop amplifiers.
The present document covers the essential requirements of article 3.2 of Directive 2014/53/EU [i.1] under the
conditions identified in annex A.

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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.

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ISO 19029:2016 specifies the sound characteristics of auditory guiding signals for persons with seeing impairment and blindness to provide the location and direction information of particular public facilities. The public facilities include facilities such as railway stations, airports, ports, bus terminals, government offices, libraries, community centres, parks, schools, hospitals, theatres, large supermarkets, and its toilets, stairs, etc. EXAMPLE As an auditory guiding signal, a chime sound is emitted from the ticket gate of a railway station. Pedestrians, including persons with seeing impairment and blindness, are able to know the location of the ticket gate by detecting the location of the chime sound. NOTE 1 The auditory guiding signals are also helpful for sighted persons. ISO 19029:2016 also specifies the design or usage of the equipment that provides auditory guiding signals. ISO 19029:2016 does not specify the characteristics of the alerts, such as alarm sounds or emergency signals. NOTE 2 The auditory danger signals are covered by ISO 7731. ISO 19029:2016 does not specify the characteristics of auditory guiding signals coming from the personal mobile equipment that is worn by persons with seeing impairment and blindness.

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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.

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IEC 60118-4:2014 is applicable to audio-frequency induction-loop systems producing an alternating magnetic field at audio frequencies and intended to provide an input signal for hearing aids operating with an induction pick-up coil (telecoil). Throughout this standard, it is assumed that the hearing aids used with it conform to all relevant parts of IEC 60118. This standard specifies requirements for the field strength in audio-frequency induction loops for hearing aid purposes, which will give adequate signal-to-noise ratio without overloading the hearing aid. The standard also specifies the minimum frequency response requirements for acceptable intelligibility. Methods for measuring the magnetic field strength are specified, and information is given on appropriate measuring equipment (see Annex B), information that should be provided to the operator and users of the system (see Annex C), and other important considerations. This standard does not specify requirements for loop driver amplifiers or associated microphone or audio signal sources, which are dealt with in IEC 62489-1, or for the field strength produced by equipment, such as telephone handsets, within the scope of ITU-T P.370. This third edition cancels and replaces the second edition published in 2006. This edition constitutes a technical revision which includes the following significant technical changes with respect to the previous edition: Addition of Annexes G, H and I where more information is provided about practical considerations and methods of measurement.

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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.

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IEC 62489-2:2014 applies to audio-frequency induction-loop systems for assisted hearing. It may also be applied to such systems used for other purposes, as far as it is applicable. The standard is intended for assessment of human exposure to low-frequency magnetic fields produced by the system, by calculation and by in-situ testing. This standard does not deal with other aspects of safety, for which IEC 60065 applies, or with EMC. This second edition cancels and replaces the first edition published in 2011. This edition constitutes a technical revision which includes significant technical changes to reflect several updates to the ICNIRP Guide (Guidelines for limiting exposure to time-varying electric, magnetic, and electromagnetic fields) to which it makes frequent reference. The most significant change is that the underlying metric in the Guide has been changed from tissue current density to induced electric field.
Keywords: hearing aid, accessibility, surdity, deafness

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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

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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.

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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.

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ISO 24501:2010 specifies methods for determining the sound pressure level range of auditory signals so that the users of consumer products, including people with age-related hearing loss, can hear the signal properly in the presence of interfering sounds.
Auditory signals, in ISO 24501:2010, refer to sounds with a fixed frequency (also called beep sounds) and do not include variable frequency sounds, melodic sounds, or voice guides.
ISO 24501:2010 is applicable to auditory signals which are heard at an approximate maximum distance of 4 m from the product, as long as no physical barrier exists between the product and the user. It is not applicable to auditory signals heard through a head receiver or earphones, or to those heard with the ear located very near to the sound source because of the interference of the head with sound propagation.
ISO 24501:2010 does not specify the sound pressure level of auditory signals regulated by other statutes, such as those for fire alarms, gas leakages and crime prevention, nor does it specify auditory signals particular to a communication tool such as telephones.
ISO 24501:2010 does not specify auditory danger signals for public or work areas which are covered in ISO 7731, ISO 8201, and ISO 11429.

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ISO 24500:2010 specifies the auditory signals used as a means of feedback for operations or conditions of consumer products when used by a person with or without visual or auditory impairment. It is intended to be applied as appropriate to such products depending on the product type and its conditions of use.
It is applicable to auditory signals of a fixed frequency used in general applications (also called “beep sounds”), but not to variable frequency or melodic sounds.
It does not specify fire or gas leak alarm sounds or crime prevention alarm sounds (determined by other laws and regulations), electronic chimes, voice guides or other sounds particular to communication instruments such as telephones; nor is it applicable to auditory danger signals for public or work areas (covered in ISO 7731, ISO 8201, and ISO 11429).
It is not applicable to machines and equipment used for professional work; nor does it specify the sound pressure levels of auditory signals from the consumer products (for the determination of these levels, taking into consideration accessible design, see ISO 24501).

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ISO 24501:2010 specifies methods for determining the sound pressure level range of auditory signals so that the users of consumer products, including people with age-related hearing loss, can hear the signal properly in the presence of interfering sounds. Auditory signals, in ISO 24501:2010, refer to sounds with a fixed frequency (also called beep sounds) and do not include variable frequency sounds, melodic sounds, or voice guides. ISO 24501:2010 is applicable to auditory signals which are heard at an approximate maximum distance of 4 m from the product, as long as no physical barrier exists between the product and the user. It is not applicable to auditory signals heard through a head receiver or earphones, or to those heard with the ear located very near to the sound source because of the interference of the head with sound propagation. ISO 24501:2010 does not specify the sound pressure level of auditory signals regulated by other statutes, such as those for fire alarms, gas leakages and crime prevention, nor does it specify auditory signals particular to a communication tool such as telephones. ISO 24501:2010 does not specify auditory danger signals for public or work areas which are covered in ISO 7731, ISO 8201, and ISO 11429.

  • Standard
    21 pages
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  • Standard
    22 pages
    French language
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Describes a method of determining the overall electro-acoustical performance of hearing aid equipment used in the rehabilitation of persons having impaired hearing.

  • Standardization document
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Defines a method of expressing the input/output ratio as an acousto-mechanical sensitivity level measured on a mechanical coupler according to the second edition of HD 590. Provides a suitable basis for the exchange of information or for direct comparison of the electroacoustic characteristics of hearing aids using bone vibrator outputs. The methods chosen are practical and reproducible and are based on selected fixed parameters.

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Applicable to insert earphones which can be fitted to an earmould inserted into the ear canal. Defines those dimensions which are essential in order to ensure interchangeability of insert earphones as used with earmoulds or other attachments to the ear.

  • Standardization document
    6 pages
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ISO 24500:2010 specifies the auditory signals used as a means of feedback for operations or conditions of consumer products when used by a person with or without visual or auditory impairment. It is intended to be applied as appropriate to such products depending on the product type and its conditions of use. It is applicable to auditory signals of a fixed frequency used in general applications (also called “beep sounds”), but not to variable frequency or melodic sounds. It does not specify fire or gas leak alarm sounds or crime prevention alarm sounds (determined by other laws and regulations), electronic chimes, voice guides or other sounds particular to communication instruments such as telephones; nor is it applicable to auditory danger signals for public or work areas (covered in ISO 7731, ISO 8201, and ISO 11429). It is not applicable to machines and equipment used for professional work; nor does it specify the sound pressure levels of auditory signals from the consumer products (for the determination of these levels, taking into consideration accessible design, see ISO 24501).

  • Standard
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  • Standard
    7 pages
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  • Standard
    12 pages
    Russian language
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IEC 62489-1:2010 applies to the components of audio-frequency induction-loop systems for assisted hearing. It may also be applied to such systems used for other purposes, as far as it is applicable. This standard is intended to encourage accurate and uniform presentation of manufacturers' specifications, which can be verified by standardized methods of measurement. It is intended for type testing. The components considered are the following:  - amplifiers;  - microphones;  - other components, such as playback equipment.  IEC 62489-1:2010 does not deal with safety, for which IEC 60065 applies. It also does  not deal with EMC (Electromagnetic compatibility) and EMF (Electromagnetic fields, in the context of human exposure).

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ISO 23600:2007 specifies requirements for acoustic and tactile signals for pedestrian traffic lights to assist in safe and independent mobility of persons with vision impairments and persons with vision and hearing impairments. It is applicable to design, installation and operation of acoustic and tactile signals for pedestrian traffic lights.

  • Standard
    8 pages
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  • Standard
    12 pages
    Russian language
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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

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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.

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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.

  • Amendment
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Gives uniform methods for specifying dynamic and static performance characteristics of hearing aids with automatic gain control circuits together with the relevant methods of measurement for these characteristics.

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To specify characteristics and related test methods for a magnetic field generated by telephone terminals for coupling to hearing aids with magnetic pick-up coils. Applicable to both analogue & digital telephony terminals

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To specify extra audio amplification & related characteristics of telephony terminals to meet the need of hard-of-hearing people.

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