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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.
 
DeviceHARMONY HIRESOLUTION BIONIC EAR SYSTEM
Generic NameImplant, cochlear
ApplicantADVANCED BIONICS
28515 WESTINGHOUSE PLACE
VALENCIA, CA 91355
PMA NumberP960058
Supplement NumberS094
Date Received11/02/2011
Decision Date04/02/2012
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 NEW ACCESSORY, CALLED T -COMM, FOR ADVANCED BIONICS BODY-WORN SOUND PROCESSORS. THIS ACCESSORY ALLOWS THE USE OF THE CURRENTLY-APPROVED T-MIC TO BE USED WITH THE BODY-WORN SOUND PROCESSORS. THE T-COMM ALSO INCORPORATES A TELECOIL. A SWITCH ALLOWS THE USER TO SELECT BETWEEN T-MIC, TELECOIL, OR A 50/50 MIX OF THE TWO INPUTS.
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