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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 056 Date of Entry 06/07/2021 
FR Recognition Number 4-274
ANSI ASA S3.2-2020
American National Standard Method for Measuring the Intelligibility of Speech over Communication Systems
This standard specifies a method for subjectively evaluating the speech intelligibility of communication systems. The standard specifies validated English word lists for performing the tests. The standard also specifies methods for selecting and training the talkers and listeners, for designing, controlling, and reporting the test conditions, and for calculating the intelligibility score, and for analyzing and reporting the test results.
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.
Transition Period
FDA recognition of ANSI/ASA S3.2-2009 (Reaffirmed 2014) [Rec# 4-183] will be superseded by recognition of ANSI/ASA S3.2-2020 [Rec# 4-274]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 4-183] until July 10, 2022. After this transition period, declarations of conformity to [Rec# 4-183] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§874.3300 Hearing Aid, Air Conduction Class 1 ESD
§874.3300 Hearing Aid, Bone Conduction Class 2 LXB
§874.3300 Hearing Aid, Bone Conduction, Implanted Class 2 MAH
§874.3950 Hearing Aid, Air Conduction, Transcutaneous System Class 2 NIX
§874.3320 Hearing Aid, Group And Auditory Trainer Class 2 EPF
§874.3320 Device, Assistive Listening Class 2 LZI
§874.3950 Hearing Aid, Air Conduction, Transcutaneous System Class 2 NIX
Relevant FDA Guidance and/or Supportive Publications*
1. Guidance for Industry: Noise Claims in Hearing Aid Labeling, Issued October 1998.

2. Guidance for Industry and Food and Drug Administration Staff: Immediately in Effect Guidance Document: Conditions for Sale for Air-Conduction Hearing Aids, Issued December 2016.
FDA Technical Contact
 Ting Zhang
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.