PMA P960058S100

Device: HIRESOLUTION BIONIC EAR SYSTEM
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S100
Product code: MCM
Decision date: 2013-03-12
Classification: Implant, Cochlear
Generic name: Implant, cochlear
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.

Current openFDA PMA Record#

Device: HIRESOLUTION BIONIC EAR SYSTEM
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S100
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2013-03-12
Decision code: APPR
Date received: 2012-11-13
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
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.