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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 040 Date of Entry 08/14/2015 
FR Recognition Number 4-220
ANSI ASA  S3.22-2014 (Reaffirmed 2020)
American National Standard Specification of Hearing Aid Characteristics
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.
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, Prescription Class 1 ESD
§874.3305 Hearing Aid, Air-Conduction With Wireless Technology, Prescription Class 2 OSM
§874.3310 Calibrator, Hearing Aid / Earphone And Analysis Systems Class 2 ETW
§874.3320 Hearing Aid, Group And Auditory Trainer Class 2 EPF
Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contacts
 Julie Cohen
 Vasant Dasika
 Lindsay DeVries
Standards Development Organizations
ANSI American National Standards Institute https://www.ansi.org/
ASA Acoustical Society of America http://acousticalsociety.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.