Hearing aids
Hearing aids are wearable medical devices intended to aid a person with impaired hearing. A hearing aid usually consists of a microphone, amplifier, signal processor and earphone, or bone conductor. Hearing aids are powered by a battery (single use or rechargeable) and possibly also containing alternative means of signal pickup such as induction coil, wireless input or electrical input. It is fitted using audiometric and prescriptive methods.
A hearing aid can be placed on the body (BW), behind the ear (BTE), in the ear (ITE, also named full concha), in the canal (ITC) or completely in the canal (CIC).
What do we cover
WG13 covers measurements and safety requirements of hearing aids. In addition there are documents describing mechanical specifications for plugs used in hearing aids, and an interface for programming digital hearing aids. Description of the measurements of basic electroacoustic parameters as gain, output, bandwidth, internal noise and distortion are key parameters in hearing aid data, but for the last decades EMC performance has become increasingly important with the widespread use of mobile phones and smart phones in close vicinity of hearing aids. High immunity to RF fields is essential for hearing aids to maintain their performance in real life situations. Advanced digital signal processing and new wireless solutions calls for continuous updates and new developments in hearing aid standards.
WG13 does not cover requirements for induction loop systems.
Why is it important
Standardisation is necessary for a range of reasons, including:
•Establishing performance requirements to enable high quality hearing aids to be produced and marketed
•Consistency in the application of measurement principles
•Safety requirements enabling the end users to safe and well functioning devices.
Experts / Countries
Active projects
Publications
IEC 60118-0:2022: Electroacoustics – Hearing aids – Part 0: Measurement of the performance characteristics of hearing aids
IEC 60118-5:1983: Hearing aids – Part 5: Nipples for insert earphones
IEC 60118-7:2005: Electroacoustics – Hearing aids – Part 7: Measurement of the performance characteristics of hearing aids for production, supply and delivery quality assurance purposes
IEC 60118-8:2005: Electroacoustics – Hearing aids – Part 8: Methods of measurement of performance characteristics of hearing aids under simulated in situ working conditions
IEC 60118-9:2019: Electroacoustics – Hearing aids – Part 9: Methods of measurement of the performance characteristics of bone conduction hearing aids
IEC 60118-12:1996: Hearing aids – Part 12: Dimensions of electrical connector systems
IEC 60118-13:2019: Electroacoustics – Hearing aids – Part 13: Requirements and methods of measurement for electromagnetic immunity to mobile digital wireless devices
IEC 60118-15:2012: Electroacoustics – Hearing aids – Part 15: Methods for characterising signal processing in hearing aids with a speech-like signal
IEC 60601-2-66:2019: Medical electrical equipment – Part 2-66: Particular requirements for the basic safety and essential performance of hearing aids and hearing aid systems
IEC 61669:2015: Electroacoustics – Measurement of real-ear acoustical performance characteristics of hearing aids
TR 62809:2019: Summary of requirements and tests to products in the scope of IEC 60601-2-66
TS 62886:2016: Electroacoustics – Hearing aids – Method for measuring electroacoustic performance up to 16 kHz
Gert Ravn
Convenor