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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 028 FR Publication Date: 03/16/2012 

Part B: Supplementary Information

Recognition Number 4-183: ANSI S3.2-2009 (Revision of ANSI S3.2-1999), american national standard method for measuring the intelligibility of speech over communication systems. (Dental/ENT)

Date of Standard: 2009. 
Address of Standards Development Organization:
 American National Standards Institute (ANSI)
  25 West 43rd Street
  4th Floor
  New York, NY 10036
 
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, Assistive Listening Devices
Processes Affected:
510(k), IDE, PMA, PDP, HDE, Quality System Regulation
Type of Standard:
 Vertical, National
Extent of Recognition:
Complete standard and any annexes.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
Unclassified Device, Assistive Listening   LZI
§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
§874.3320 Hearing Aid, Group And Auditory Trainer Class 2 EPF
§874.3950 Hearing Aid, Air Conduction, Transcutaneous System Class 2 NIX
Relevant Guidance:
Guidance for Industry - Noise Claims in Hearing Aid 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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