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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 031 Date of Entry 08/06/2013 
FR Recognition Number 4-90
ANSI ASA  S3.39:1987 (Reaffirmed 2020)
American National Standard Specifications for Instruments to Measure Aural Acoustic Impedance and Admittance (Aural Acoustic Immittance)
The instruments covered by this standard are designed primarily for the measurement of acoustic impedance, acoustic admittance, or both quantities, within the human external auditory meatus. The standard is concerned with the parameters and tolerances of instruments used for measurement of aural acoustic impedance and aural acoustic admittance when the probe-tone frequency is 226 Hz. It is not within the scope of this standard to establish normative values for human ears....

The purpose of this standard is to ensure that acoustic-impedance or acoustic-admittance measurements will be substantially the same for a given ear when these measurements are obtained with any instruments that meet the specifications and tolerances outlined in this standard, and when comparable test conditions prevail. This standard is not intended to inhibit development, to restrict incorporation of new features (such ads probe frequencies other than 226 Hz), or to discourage other improvements that may become useful in the measurement of aural acoustic impedance or acoustic admittance.
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
§874.1090 Tester, Auditory Impedance Class 2 ETY
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
 Julie Cohen
 Lindsay DeVries
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.