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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 040 Date of Entry 08/14/2015 
FR Recognition Number 4-184
ANSI ASA  S3.25-2009 (Reaffirmed 2019)
American National Standard For an Occluded Ear Simulator
Ear simulators are intended for earphone response determination, measurement of hearing aid gain and performance, and measurements requiring simulation of the sound transmission characteristics of an external ear. Measurements performed with ear simulators are intended to provide data equivalent to sound pressures at the eardrum generated by sound sources in and around the ear.

This standard gives acoustical performance criteria for a device that provides acoustic impedance and exhibits sound-pressure distributions approximating the median adult human ear between an ear mold and the eardrum. Two specific embodiments whose performance conforms to these criteria are described. Construction details can be found in the annexes.

As a simulation of part of a median adult human ear, the occluded ear simulator is suitable for use in test systems such as manikins, where the complete ear is to be simulated.

Procedures are given for determining that the occluded ear simulator has the specified acoustic performance.
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
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 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.