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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 036 Date of Entry 07/09/2014 
FR Recognition Number 4-160
ANSI ASA  S3.1-1999 (Reaffirmed 2023)
American National Standard Maximum Permissible Ambient Noise Levels for Audiometric Test Rooms
Hearing measurements in an audiometric test room may be conducted for different audiometric purposes over different test frequency ranges. However, if the ambient noise level is excessively high, some hearing threshold levels measured in that environment will be inaccurate. This occurs because excessively high ambient noise will create an elevation of hearing threshold levels. This is a psychoacoustic phenomenon called masking.

Exclusion of all ambient noise from an audiometric test room is not feasible nor practical from structural and cost considerations. However, to ensure that hearing tests are not influenced by excessive ambient noise masking, there is a need to specify maximum permissible ambient noise levels (MPANLs) that can be allowed in an audiometric test room. This is true particularly when testing is done at sound pressure levels for pure tones corresponding to 0 dB hearing level. Further, there is a need to specify MPANLs for different audiometric conditions, test frequency ranges, and earphone types that will permit testing at reference equivalent threshold levels specified in ANSI S3.6- 1996 American National Standard Specification for Audiometers.

This Standard includes the specification and measurement of MPANLs in an audiometric test room. Within this Standard, MPANLs are specified for octave and one-third octave band intervals from 125 to 8000 Hz for the audiometric conditions of testing with ears covered using a supra-aural and insert earphone and ears not covered for the test frequency ranges 125 to 8000 Hz, 250 to 8000 Hz, and 500 to 8000 Hz.
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
§874.1060 Chamber, Acoustic (For Audiometric Testing) Class 1 EWC
§874.1080 Set, Audiometer Calibration Class 1 EWA
§874.1090 Tester, Auditory Impedance Class 2 ETY
§874.1090 Tympanometer Class 2 NAS
§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*
1. Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Transcutaneous Air Circulation Hearing Aid System (TACHAS), issued November 2002.

2. Guidance for Industry and FDA Staff: Implantable Middle Ear Hearing Device, issued August 2003.

3. Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Tinnitus Masker Devices, issued November 2005.

4. Guidance for Industry: Noise Claims in Hearing Aid Labeling Document, issued October 1998.

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
 Lindsay DeVries
 Julie Cohen
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)
*These are provided as examples and others may be applicable.