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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 043 Date of Entry 06/27/2016 
FR Recognition Number 4-228
Standard
ANSI ASA  S3.20-2015 (Reaffirmed 2020)
American National Standard Bioacoustical Terminology
Scope/Abstract
This American National Standard provides definitions for terms used in human bioacoustics. Some additional general terms for measurement and instruments related to applications in psychoacoustics are also provided.

Acoustical terms of more general use in the performance of acoustical measurements, the properties of electroacoustic transducers, and applications in the fields of architectural acoustics, environmental acoustics, underwater sound, and music are provided in ANSI/ASA S1.1-2013 American National Standard Acoustical Terminology. A selected set of terms from clause 3 of ANSI/ASA S1.1-2013 involving acoustical levels is listed here in Annex A, and terms from clause 6 on transducer and linear system properties are included here as Annex B. The entire clause 11 of ANSI/ASA S1.1-2013 containing psychoacoustics and physiological acoustical terminology is included here in Annex C, and the entire clause 12 on musical acoustics is included here in Annex D. All terms defined in the body of the text and in the annexes are listed in an alphabetical index.
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
§874.1050 Audiometer Class 2 EWO
§874.1060 Chamber, Acoustic (For Audiometric Testing) Class 1 EWC
§874.1080 Set, Audiometer Calibration Class 1 EWA
§874.1090 Tester, Auditory Impedance Class 2 ETY
§874.1090 Tympanometer Class 2 NAS
§874.3300 Hearing Aid, Air-Conduction, Prescription Class 1 ESD
§874.3302 Hearing Aid, Bone Conduction Class 2 LXB
§874.3302 Hearing Aid, Bone Conduction, Implanted Class 2 MAH
§874.3305 Hearing Aid, Air-Conduction With Wireless Technology, Prescription Class 2 OSM
§874.3320 Device, Assistive Listening Class 2 LZI
§874.3400 Masker, Tinnitus Class 2 KLW
§874.3950 Hearing Aid, Air Conduction, Transcutaneous System Class 2 NIX
N/A Implant, Cochlear Class 3 MCM
N/A Implant, Auditory Brainstem Class 3 MHE
N/A Implant, Hearing, Active, Middle Ear, Partially Implanted Class 3 MPV
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
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-5365
  Vasant.Dasika@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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