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 NumberS100
Date Received11/13/2012
Decision Date03/12/2013
Product Code MCM 
Advisory Committee Ear Nose & Throat
Clinical TrialsNCT01616576
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE HIRES OPTIMA SOUND PROCESSING STRATEGY. HIRES OPTIMA IS A MODIFICATION OF THE HIRES FIDELITY 120 STRATEGY, AND IS INTENDED TO OPTIMIZE POWER EFFICIENCY. THIS NEW STRATEGY IMPROVES BATTERY LIFE WITHOUT COMPROMISING THE LISTENING BENEFITS OF THE HIRESOLUTION BIONIC EAR SYSTEM.