ANSI ASA S3.46-2013

Standard Organization:

ANSI ASA S3.46-2013
American National Standard Methods of Measurement of Real-Ear Performance Characteristics of Hearing Aids

Recognition Date2014-07-09
Recognition List036
Recognition Number4-211
Extent Complete standard
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STG Dental/ENT
FDA Tech  Shu-Chen Peng   FDA/OMPT/CDRH/ODE/DOED/ENTB/   301-796-6481   shu-chen.peng@fda.hhs.gov

Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

This standard covers the terminology, procedures and essential equipment characteristics for the measurement of the acoustic output and acoustic gain of hearing aids, coupled to human ears, in a variety of acoustic environments and for the measurement of certain acoustic properties of the ear related to the application of hearing aids. These measurements can be divided into two classes: a) direct measures of sound pressure level (SPL), and b) insertion measurements. Direct measures (previously called in situ measurements) report SPL developed in an ear canal, with or without a hearing aid in place and are expressed as dB gain relative to the SPL at a field reference point. Insertion measurements report ear canal SPL with a hearing aid in place relative to the ear canal SPL without the hearing aid. Behavioral measures of real-ear hearing aid performance, such as functional gain, are excluded from this standard.

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
§874.3950 Hearing Aid, Air Conduction, Transcutaneous System Class 2 NIX
§874.3300 Hearing Aid, Air Conduction Class 1 ESD
§874.3950 Hearing Aid, Air Conduction, Transcutaneous System Class 2 NIX

FDA Guidance:

There is no relevant guidance developed at this time.

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