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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 4-211
ANSI ASA  S3.46-2013 (Reaffirmed 2023)
American National Standard Methods of Measurement of Real-Ear Performance Characteristics of Hearing Aids
This standard covers the terminology, procedures and essential equipment characteristics for the measurement of the acoustic output and acoustic gain of hearing aids, coupled to human ears, in a variety of acoustic environments and for the measurement of certain acoustic properties of the ear related to the application of hearing aids. These measurements can be divided into two classes: a) direct measures of sound pressure level (SPL), and b) insertion measurements. Direct measures (previously called in situ measurements) report SPL developed in an ear canal, with or without a hearing aid in place and are expressed as dB gain relative to the SPL at a field reference point. Insertion measurements report ear canal SPL with a hearing aid in place relative to the ear canal SPL without the hearing aid. Behavioral measures of real-ear hearing aid performance, such as functional gain, are excluded from this standard.
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
§874.3300 Hearing Aid, Air-Conduction, Prescription Class 1 ESD
§874.3950 Hearing Aid, Air Conduction, Transcutaneous System Class 2 NIX
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.