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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 041 Date of Entry 04/04/2016 
FR Recognition Number 4-190
Standard
ANSI ASA  S3.35-2010 (Reaffirmed 2020)
American National Standard Method for Measurement of Performance Characteristics of Hearing Aids under Simulated Real-Ear Working Conditions
Scope/Abstract
The purpose of this standard is to describe test methods which include the acoustical effects of a simulated median adult wearer on the performance of a hearing aid.

Measurements made under simulated real-ear aided working conditions may be divided into two classes:
- Direct simulated real-ear aided measurements, which determine the sound pressure developed by a hearing aid in an ear simulator for a given free-field input sound pressure.
- Insertion measurements, which determine the difference between the sound pressures developed in the ear simulator with and without a hearing aid in place.

Such measurements attempt to determine the actual acoustical assistance that a hearing aid gives to a user.

The test methods described in this document are not intended for quality control.

The results obtained under simulated real-ear aided conditions may differ substantially from results obtained on an individual person due to anatomical and physiological variations of heads, torsos, pinnae, ear canals, and eardrums.

The methods recommended in this standard give information on the measurement of the following parameters that are considered important for the evaluation of the performance of a hearing aid as normally worn, and for which simulated real-ear aided conditions are considered essential: insertion gain
- real-ear aided output sound-pressure level for 90 dB input sound-pressure level
- directional characteristics.
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FDA recognition of ANSI, ASA S3.35-2010 (Reaffirmed 2020) [Rec# 4-190] will be superseded by recognition of ANSI, ASA S3.35-2021 [Rec# 4-312].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
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB
  301-796-5365
  Vasant.Dasika@fda.hhs.gov
 Lindsay DeVries
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB
  240-402-1462
  Lindsay.DeVries@fda.hhs.gov
 Julie Cohen
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB
  301-796-0772
  Julie.Cohen@fda.hhs.gov
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)
Dental/ENT
*These are provided as examples and others may be applicable.
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