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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 036 FR Publication Date: 07/09/2014 

Part B: Supplementary Information

Recognition Number 4-177: ANSI / ASA S12.65-2006 (Reaffirmed 2011), american national standard for rating noise with respect to speech interference. (Dental/ENT)

Date of Standard: 2006. 
Addresses of Standards Development Organizations:
 American National Standards Institute (ANSI)
  25 West 43rd Street
  4th Floor
  New York, NY 10036
 
 Acoustical Society of America (ASA)
  500 Sunnyside Boulevard
  Woodbury, NY 11797-2999
 
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
DIVISION OF OPHTHALMIC AND EAR, NOSE AND THROAT DEVICES (DOED)
Devices Affected:
Hearing Aids, Implantable Middle-Ear Hearing Devices, Cochlear Implants, Auditory Brainstem Implants
Processes Affected:
510(k), IDE, PMA, PDP, HDE, Quality System Regulation
Type of Standard:
 Horizontal, National
Extent of Recognition:
Complete standard and any annexes.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
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
§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
§874.3950 Hearing Aid, Air Conduction, Transcutaneous System Class 2 NIX
Relevant Guidance:
Guidance for Industry - Noise Claims in Hearing Air Labeling Document issued on: October 21, 1998
FDA Technical Contact:
 Shu-Chen Peng
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66 Room 2446
  Silver Spring MD 20993
  301/796-6481
  email: shu-chen.peng@fda.hhs.gov
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