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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 056 Date of Entry 06/07/2021 
FR Recognition Number 4-275
Standard
ANSI ASA  S3.6-2018
American National Standard for Specification for Audiometers
Scope/Abstract
The audiometers covered in this specification are devices designed for use in determining the hearing threshold level of an individual in comparison with a chosen standard reference threshold level. This standard provides specifications and tolerances for pure tone, speech, and masking signals and describes the minimum test capabilities of different types of audiometers.

This standard classifies audiometers according to the type of signal generated (pure tones, speech, or both), mode of operation, and complexity or range of auditory functions tested. Audiometers are also classified by type. Audiometers used for diagnostic assessment are classified as Types 1, 2, or 3, while audiometers having air-conduction facilities only are classified as Type 4.
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
§874.1050 Audiometer Class 2 EWO
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 Contact
 Vasant Dasika
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB
  301-796-5365
  Vasant.Dasika@fda.hhs.gov
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)
Dental/ENT
*These are provided as examples and others may be applicable.
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