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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 038 Date of Entry 01/27/2015 
FR Recognition Number 4-183
ANSI ASA S3.2-2009 (Reaffirmed 2014)
American National Standard Method for Measuring the Intelligibility of Speech over Communication Systems
The scope of this standard includes the measurement of the intelligibility of speech over entire communication systems and the evaluation of the contributions of elements of speech communication systems. The scope also includes evaluation of the factors that affect the intelligibility of speech.

In this standard the intelligibility of speech over a speech communication system is measured by comparing the monosyllabic words trained listeners receive and identify with the words trained talkers or speech coders speak into a communication system that connects the talkers (or speech coders) with the listeners. The standard requires the intelligibility measurements to be made with talkers and listeners who are native speakers of English and who have no speech or hearing defects.
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FDA recognition of ANSI/ASA S3.2-2009 (Reaffirmed 2014) [Rec# 4-183] will be superseded by recognition of ANSI/ASA S3.2-2020 [Rec# 4-274].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.