• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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 2020)
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.
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FDA recognition of ANSI/ASA S3.7-1995 (Reaffirmed 2008) [Rec# 4-164] will be superseded by recognition of ANSI/ASA S3.7-2016 (Reaffirmed 2020) [Rec# 4-273].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
  FDA/OC/CDRH/OPEQ/OHTI/DHTIC/
  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.
-
-