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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 051 Date of Entry 01/14/2019 
FR Recognition Number 4-162
Standard
ANSI ASA  S3.4-2007 (Reaffirmed 2020)
American National Standard Procedure for the Computation of Loudness of Steady Sounds
Scope/Abstract
This standard specifies a procedure for calculating the monaural and binaural loudness of steady sounds as perceived by listeners with normal hearing. The procedure is based on the spectra of the sounds. The possible sounds include simple and complex tones (both harmonic and inharmonic), bands of noise and mixtures of tones and noise. The spectra can be specified exactly, in terms of the frequencies and levels of individual spectral components, or approximately, in terms of the levels in 1/3 octave bands covering center frequencies from 50 to 16,000 Hz. The standard is applicable to sounds presented in free field with a frontal incidence, in a diffuse field, or listening via headphones.
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
§874.3302 Hearing Aid, Bone Conduction Class 2 LXB
§874.3302 Hearing Aid, Bone Conduction, Implanted Class 2 MAH
§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 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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