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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 036 Date of Recognition 07/09/2014 
FR Recognition Number 4-177
Standard
ANSI ASA S12.65-2006 (Reaffirmed 2011)
American National Standard For Rating Noise with Respect to Speech Interference
Scope/Abstract
This standard defines a simple numerical method for rating the expected speech-interfering aspects of noise using acoustical measurements of the noise. The relevant acoustical characteristics of the noise are summarized in terms of a single-valued index known as the speech interference level. The application of the measure is intended for natural speech.
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
§874.3300 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
Guidance for Industry - Noise Claims in Hearing Air Labeling Document issued on: October 21, 1998
FDA Technical Contact
 Shu-Chen Peng
  FDA/OMPT/CDRH/ODE/DOED/ENTB/
  301-796-6481
  shu-chen.peng@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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