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U.S. Department of Health and Human Services

Recognized Consensus Standards

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FR Publication Date: 01/30/2014 

Part B: Supplementary Information

ANSI S3.22:2003, specification of hearing aid characteristics - includes april 2007 erratum. (Dental/ENT)
Address of Standards Development Organization:
 American National Standards Institute (ANSI)
  25 West 43rd Street
  4th Floor
  New York, NY 10036
 
CDRH Offices and Divisions associated with recognized standards:
(1)OFFICE OF DEVICE EVALUATION (ODE)
DIVISION OF OPHTHALMIC AND EAR, NOSE AND THROAT DEVICES (DOED)
(2)OFFICE OF COMPLIANCE (OC)
Devices Affected:
Air-Conduction Hearing Aid Calibrator and Analysis System
Processes Affected:
510(k), PMA, PDP, IDE, HDE, Design Control Input, Quality System Regulation
Type of Standard:
 National, Vertical
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
§874.3310 Calibrator, Hearing Aid / Earphone And Analysis Systems Class 2 ETW
§874.3320 Hearing Aid, Group And Auditory Trainer Class 2 EPF
FDA Technical Contact:
 Teresa Cygnarowicz
  FDA/CDRH/ODE
  9200 CORPORATE BLVD, HFZ-460
  ROCKVILLE MD 20850
  240/276-4247
  email: teresa.cygnarowicz@fda.hhs.gov
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