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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 043 Date of Recognition 06/27/2016 
FR Recognition Number 4-228
Standard
ANSI ASA S3.20-2015 (Revision of ANSI S3.20-1995)
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
§874.3950 Hearing Aid, Air Conduction, Transcutaneous System Class 2 NIX
§874.3400 Masker, Tinnitus Class 2 KLW
§874.3305 Hearing Aid, Air Conduction With Wireless Technology Class 2 OSM
§874.3300 Hearing Aid, Air Conduction Class 1 ESD
§874.3300 Hearing Aid, Bone Conduction Class 2 LXB
§874.3300 Hearing Aid, Bone Conduction, Implanted Class 2 MAH
§874.1090 Tester, Auditory Impedance Class 2 ETY
§874.1090 Tympanometer Class 2 NAS
§874.1080 Set, Audiometer Calibration Class 1 EWA
§874.1060 Chamber, Acoustic (For Audiometric Testing) Class 1 EWC
§874.1050 Audiometer Class 2 EWO
Unclassified Implant, Auditory Brainstem Class 3 MHE
Unclassified Implant, Cochlear Class 3 MCM
Unclassified Implant, Hearing, Active, Middle Ear, Partially Implanted Class 3 MPV
§874.3320 Device, Assistive Listening Class 2 LZI
§874.3950 Hearing Aid, Air Conduction, Transcutaneous System Class 2 NIX
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
FDA Technical Contact
 Vasant Dasika
  FDA/OMPT/CDRH/ODE/DOED/ENTB/
  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
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