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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 051 Date of Entry 01/14/2019 
FR Recognition Number 4-171
Standard
ANSI ASA S3.37-1987 (Reaffirmed 2020)
American National Standard Preferred Earhook Nozzle Thread for Postauricular Hearing Aids
Scope/Abstract
This standard applies only to those postauricular hearing aids which utilize screw-on threads.
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
§874.3300 Hearing Aid, Air-Conduction, Prescription Class 1 ESD
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
 Shu-Chen Peng
  FDA/OC/CDRH/OPEQ/OHTI/DHTIC/
  301-796-6481
  shu-chen.peng@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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