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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 031 Date of Recognition 08/06/2013 
FR Recognition Number 4-204
Standard
ANSI ASA IEC S3.42-2012/Part 2/ IEC 60118-15:2012
American National Standard Testing Hearing Aids - Part 2: Methods for characterizing signal processing in hearing aids with a speech-like signal (a nationally adopted international standard)
Scope/Abstract
This American National Standard 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 procedure uses a speech-like test signal and the hearing aid settings are set to those programmed for an individual end-user or those recommended by the manufacturer for a typical enduser for a range of flat, moderately sloping or steep sloping audiograms, so that the measured characteristics are comparable to those which may be obtained by a wearer at typical user settings.

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.

Measurements of the characteristics of signal processing in hearing aids which apply non-linear processing techniques are valid only for the test signal used. Measurements which require a different test signal or test conditions are outside the scope of this standard.

Conformance to the specifications in this 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 standard as given by the values given in 6.1.

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.

Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§874.3300 Hearing Aid, Air Conduction Class 1 ESD
§874.3300 Hearing Aid, Bone Conduction Class 2 LXB
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
FDA Technical Contact
 Shu-Chen Peng
  FDA/OMPT/CDRH/ODE/DOED/ENTB/
  301-796-6481
  shu-chen.peng@fda.hhs.gov
Standards Development Organizations
ANSI American National Standards Institute https://www.ansi.org/
ASA Acoustical Society of America http://acousticalsociety.org/
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
Dental/ENT
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