HIRESOLUTION BIONIC EAR SYSTEM
FDA premarket approval P960058/S100 · decided 2013-03-12
Approval details
- PMA number
- P960058
- Supplement
- S100
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HIRESOLUTION BIONIC EAR SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics
- Date received
- 2012-11-13
- Decision date
- 2013-03-12
- Days to decision
- 119 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- 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.
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