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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 051 Date of Recognition 01/14/2019 
FR Recognition Number 4-162
Standard
ANSI S3.4-2007 (Reaffirmed 2017)
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
§874.3950 Hearing Aid, Air Conduction, Transcutaneous System Class 2 NIX
§874.3400 Masker, Tinnitus Class 2 KLW
§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
Unclassified Implant, Auditory Brainstem Class 3 MHE
Unclassified Implant, Cochlear Class 3 MCM
Unclassified Implant, Hearing, Active, Middle Ear, Partially Implanted Class 3 MPV
§874.3950 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
 Shu-Chen Peng
  FDA/OMPT/CDRH/ODE/DOED/ENTB/
  301-796-6481
  shu-chen.peng@fda.hhs.gov
Standards Development Organization
ANSI American National Standards Institute https://www.ansi.org/
FDA Specialty Task Group (STG)
Dental/ENT
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