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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 031 FR Publication Date: 08/05/2013 

Part B: Supplementary Information

Recognition Number 4-204: ANSI / ASA / IEC S3.42-2012/Part 2/ IEC 60118-15:2012, american national standard testing hearing aids - part 2: methods for characterizing signal processing in hearing aids with a speech-like signal (a nationally adopted international standard). (Dental/ENT)

Date of Standard: 2012. 
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
 
 International Electrotechnical Commission (IEC)
  3, Rue de Varembe'
  PO Box 131
  CH-1211 Geneva 20, 0
  SWITZERLAND
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
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
§874.3300 Hearing Aid, Air Conduction Class 1 ESD
§874.3300 Hearing Aid, Bone Conduction Class 2 LXB
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
* in the United States, copies of this standard can be obtained from:
  American National Standards Institute (ANSI)*
  25 West 43rd Street
  4th Floor
  New York, NY 10036
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