|
Device | HIRESOLUTION BIONIC EAR SYSTEM |
Generic Name | implant, cochlear |
Applicant |
ADVANCED BIONICS |
28515 westinghouse place |
valencia, CA 91355 |
|
PMA Number | P960058 |
Supplement Number | S100 |
Date Received | 11/13/2012 |
Decision Date | 03/12/2013 |
Product Code |
MCM
|
Advisory Committee |
Ear Nose & Throat |
Supplement Type | normal 180 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product |
No
|
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. |