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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 4-273
Standard
ANSI ASA  S3.7-2016 (Reaffirmed 2023)
American National Standard Method for Coupler Calibration of Earphones
Scope/Abstract
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.
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
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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