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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 028 Date of Recognition 03/16/2012 
FR Recognition Number 4-173
ANSI S3.44-1996 Reaffirmed by ANSI on 27 April 2006
American National Standard Determination of Occupational Noise Exposure and Estimation of Noise-Induced Hearing Impairment
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§874.3400 Masker, Tinnitus Class 2 KLW
§874.3300 Hearing Aid, Air Conduction Class 1 ESD
Relevant FDA Guidance and/or Supportive Publications
Draft Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Tinnitus Maskers Devices. Document issued on November 8, 2005
FDA Technical Contact
 Shu-Chen Peng
Standards Development Organization
ANSI American National Standards Institute https://www.ansi.org/
FDA Specialty Task Group (STG)