HIRESOLUTION BIONIC EAR SYSTEM
FDA premarket approval P960058/S033 · decided 2004-02-18
Approval details
- PMA number
- P960058
- Supplement
- S033
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HIRESOLUTION BIONIC EAR SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics
- Date received
- 2004-02-09
- Decision date
- 2004-02-18
- Days to decision
- 9 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- APPROVAL FOR A NEW AURIA (BEHIND-THE-EAR) ACCESSORY, CALLED THE AURIA T-COIL. THE ACCESSORY PROVIDES AURIA USERS AN OPTIONAL INTERFACE FOR TELEPHONES AND INDUCTION LOOP-BASED ASSISTIVE LISTENING SYSTEM.
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