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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 4-273
ANSI ASA S3.7-2016 (Reaffirmed 2020)
American National Standard Method for Coupler Calibration of Earphones
This standard describes measurement methods for earphones and earphone transducers using couplers or ear simulators. Guidance is provided for the selection of the appropriate coupler or ear simulator for a given earphone and application. Methods for measurement of calibrated frequency response, input-output linearity, electrical impedance, and non-linear distortion, are described.
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FDA recognition of ANSI/ASA S3.7-1995 (Reaffirmed 2008) [Rec# 4-164] will be superseded by recognition of ANSI/ASA S3.7-2016 (Reaffirmed 2020) [Rec# 4-273]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 4-164] until July 10, 2022. After this transition period, declarations of conformity to [Rec# 4-164] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§874.1050 Audiometer Class 2 EWO
§874.1080 Set, Audiometer Calibration Class 1 EWA
FDA Technical Contact
 Vasant Dasika
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.