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prSSH EN IEC 60118-0:2024

Electroacoustics - Hearing aids - Part 0: Measurement of the performance characteristics of hearing aids

General information

10.00     Nov 7, 2024

DPS

DPS/KT 8

European Norm

17.140.50  

Scope

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.

Related directives

Directives related to this standards.

2017/745

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

Life cycle

PREVIOUSLY

PUBLISHED
SSH EN 60118-0:2015

NOW

IN_DEVELOPMENT
prSSH EN IEC 60118-0:2024
10.00 Proposal for new project registered
Nov 7, 2024

Related project

Adopted from EN IEC 60118-0:2024 IDENTICAL

Adopted from IEC 60118-0:2022 ED4 IDENTICAL