ANSI ASA S3.22-2014

Standard Organization:

ANSI ASA S3.22-2014
American National Standard Specification of Hearing Aid Characteristics

Recognition Date2015-08-14
Recognition List040
Recognition Number4-220
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 describes certain hearing aid measurements and parameters that are deemed useful in determining the electroacoustic performance of an air-conduction hearing aid. Some of these lend themselves to setting of tolerances for the purpose of maintaining product uniformity and for compliance with the performance specified for a model.

It is not the intent of this document to restrict the variety of hearing aid performance available nor to inhibit in any way advances in the state of the art.

This standard is limited to the specification of certain electroacoustic characteristics based on sinusoidal and other steady-state test signals. Measurements described in this standard are not intended to reflect in situ performance of hearing aids, directional performance of directional hearing aids, or certain performance properties of digital hearing aids, such as processing delay.

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
§874.3320 Hearing Aid, Group And Auditory Trainer Class 2 EPF
§874.3310 Calibrator, Hearing Aid / Earphone And Analysis Systems Class 2 ETW
§874.3305 Hearing Aid, Air Conduction With Wireless Technology Class 2 OSM
§874.3300 Hearing Aid, Air Conduction Class 1 ESD

FDA Guidance:

There is no relevant guidance developed at this time.

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