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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 053 Date of Entry 12/23/2019 
FR Recognition Number 4-260
ANSI ASA  S12.2-2019
American National Standard for Criteria for Evaluating Room Noise
The three primary methods for evaluating room noise are:
1. The survey method that employs the A-weighted sound level;
2. The engineering method that employs noise criteria (NC) curves; and
3. The method for evaluating low-frequency fluctuating noise using room noise criteria (RNC)

This Standard also contains one ancillary set of criteria curves for evaluating acoustically induced
vibrations or rattles.

Requirements are given in the body of the Standard for determining whether a:
1. Measured or estimated A-weighted sound level satisfies a specified noise criterion.
2. Set of octave-band sound pressure levels satisfies a specified NC curve.
3. Time-series of octave-band sound pressure levels satisfies a specified RNC curve.
4. Table of octave-band sound pressure levels that, when modulated by fluctuations at low
frequencies, may cause perceptible vibrations or rattles in lightweight constructions.
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
§874.1090 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*
Class II Special Controls Guidance Document: Transcutaneous Air Conduction Hearing Aid System (TACHAS); Guidance for Industry and FDA, issued November 2002.

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

Guidance for Industry - Noise Claims in Hearing Aid Labeling, 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 Contact
 Vasant Dasika
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.