HIRESOLUTION BIONIC EAR SYSTEM
FDA premarket approval P960058/S047 · decided 2006-04-11
Approval details
- PMA number
- P960058
- Supplement
- S047
- 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
- 2005-10-27
- Decision date
- 2006-04-11
- Days to decision
- 166 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- APPROVAL FOR A REVISION TO THE AURIA BEHIND-THE-EAR SOUND PROCESSOR, WHICH WILL BE MARKETED UNDER THE TRADE NAME AURIA HARMONY. THE REVISION INCORPORATES NEW CIRCUITRY, FIRMWARE, AND COMPONENTS, INCLUDING A NEW DIGITAL SIGNAL PROCESSOR CHIP, INTERNAL TELECOIL, BUILT-IN DIAGNOSTIC LIGHT EMITTING DIODE (LED), IMPROVED AUDIO FRONT END, AND ENHANCED FRF TRANSMITTER.
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