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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceHIRESOLUTION BIONIC EAR SYSTEM
Generic NameImplant, cochlear
ApplicantADVANCED BIONICS
28515 WESTINGHOUSE PLACE
VALENCIA, CA 91355
PMA NumberP960058
Supplement NumberS047
Date Received10/27/2005
Decision Date04/11/2006
Product Code MCM 
Advisory Committee Ear Nose & Throat
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR A REVISION TO THE AURIA BEHIND-THE-EAR SOUND PROCESSOR, WHICH WILL BE MARKETED UNDER THE TRADE NAME AURIA HARMONY. THE REVISION INCORPORATES NEW CIRCUITRY, FIRMWARE, AND COMPONENTS, INCLUDING A NEW DIGITAL SIGNAL PROCESSOR CHIP, INTERNAL TELECOIL, BUILT-IN DIAGNOSTIC LIGHT EMITTING DIODE (LED), IMPROVED AUDIO FRONT END, AND ENHANCED FRF TRANSMITTER.
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