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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 031 Date of Entry 08/06/2013 
FR Recognition Number 4-167
Standard
ANSI ASA  S3.21-2004 (Reaffirmed 2023)
American National Standard Methods for Manual Pure-Tone Threshold Audiometry
Scope/Abstract
Pure-tone threshold audiometry is the procedure used in the assessment of an individual's threshold of hearing for pure tones. Pure-tone threshold audiometry includes manual air-conduction measurements at octave intervals from 250 through 8000 Hz and at intermediate frequencies as needed. When abrupt differences of 20 dB or more occur between adjacent octave frequencies, additional frequencies may be included at the discretion of the tester. Bone-conduction measurements may be carried out if indicated by the test requirements at octave intervals from 250 through 4000 Hz. Also, when required, masking is to be used. The purpose of this standard is to present procedures for conducting manual pure-tone threshold audiometry whose use will minimize intertest differences based on test method.
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
§874.3300 Hearing Aid, Air-Conduction, Prescription Class 1 ESD
§874.3302 Hearing Aid, Bone Conduction Class 2 LXB
§874.3302 Hearing Aid, Bone Conduction, Implanted Class 2 MAH
§874.3400 Masker, Tinnitus Class 2 KLW
§874.3950 Hearing Aid, Air Conduction, Transcutaneous System Class 2 NIX
N/A Implant, Cochlear Class 3 MCM
N/A Implant, Auditory Brainstem Class 3 MHE
N/A Implant, Hearing, Active, Middle Ear, Partially Implanted Class 3 MPV
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 Contacts
 Vasant Dasika
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-5365
  Vasant.Dasika@fda.hhs.gov
 Lindsay DeVries
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  240-402-1462
  Lindsay.DeVries@fda.hhs.gov
 Julie Cohen
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-0772
  Julie.Cohen@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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