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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 028 Date of Entry 03/16/2012 
FR Recognition Number 4-173
ANSI ASA  S3.44-1996 (Reaffirmed 2006)
American National Standard for Determination of Occupational Noise Exposure and Estimation of Noise-Induced Hearing Impairment
The standard is an adaptation of the international standard ISO 1999:1990(E) of the same name. Unlike the international standard, this standard allows assessment of noise exposure using a time/intensity trading relation other than a 3-decibel increase per halving of exposure time. This standard presents, in statistical terms, the relationship between noise exposures and changes in hearing threshold levels for a noise exposed population. This standard can also be applied to the calculation of the risk of incurring hearing handicap from sustained daily exposure to noise. Guidance is provided as to the measurement of noise exposure.
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
§874.3400 Masker, Tinnitus Class 2 KLW
Relevant FDA Guidance and/or Supportive Publications*
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Tinnitus Maskers Devices, issued November 2005.

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
 Vasant Dasika
 Lindsay DeVries
 Julie Cohen
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.