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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 061 Date of Entry 12/18/2023 
FR Recognition Number 4-312
ANSI ASA  S3.35-2021
American National Standard Method for Measurement of Performance Characteristics of Hearing Aids Under Simulated Real-Ear Working Conditions
This standard describes techniques used to measure hearing aids under simulated conditions of real ear use. For the purpose of these measurements, a standard manikin and ear simulator are used to represent a typical hearing aid wearer. Acoustical requirements of the test space as well as how the manikin is positioned with respect to the sound source are given. Two methods are presented to control the level of the incident sound field during the testing. Procedures are provided to obtain both the aided gain and the insertion gain, in order to determine the increase in sound pressure relative to the unaided condition, with and without the acoustical effect of the manikin. Procedures are also provided to obtain the directional response of the hearing aid on the manikin as a function of azimuth and elevation of the sound source, and to calculate the directivity index from the directional response.
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.
Transition Period
FDA recognition of ANSI, ASA S3.35-2010 (Reaffirmed 2020) [Rec# 4-190] will be superseded by recognition of ANSI, ASA S3.35-2021 [Rec# 4-312]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 4-190] until December 21, 2025. After this transition period, declarations of conformity to [Rec# 4-190] will not be accepted.
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 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.