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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 031 Date of Entry 08/06/2013 
FR Recognition Number 4-167
ANSI S3.21-2004 (Reaffirmed 2009) American National Standard Methods for Manual Pure-Tone Threshold Audiometry
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 Class 1 ESD
§874.3300 Hearing Aid, Bone Conduction Class 2 LXB
§874.3300 Hearing Aid, Bone Conduction, Implanted Class 2 MAH
§874.3950 Hearing Aid, Air Conduction, Transcutaneous System Class 2 NIX
§874.3400 Masker, Tinnitus Class 2 KLW
Unclassified Implant, Auditory Brainstem Class 3 MHE
Unclassified Implant, Cochlear Class 3 MCM
Unclassified Implant, Hearing, Active, Middle Ear, Partially Implanted Class 3 MPV
§874.3950 Hearing Aid, Air Conduction, Transcutaneous System Class 2 NIX
FDA Technical Contact
 James K. Kane
Standards Development Organization
ANSI American National Standards Institute https://www.ansi.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.