HARMONY HIRESOLUTION BIONIC EAR SYSTEM
FDA premarket approval P960058/S094 · decided 2012-04-02
Approval details
- PMA number
- P960058
- Supplement
- S094
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HARMONY HIRESOLUTION BIONIC EAR SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics
- Date received
- 2011-11-02
- Decision date
- 2012-04-02
- Days to decision
- 152 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- APPROVAL FOR A NEW ACCESSORY, CALLED T -COMM, FOR ADVANCED BIONICS BODY-WORN SOUND PROCESSORS. THIS ACCESSORY ALLOWS THE USE OF THE CURRENTLY-APPROVED T-MIC TO BE USED WITH THE BODY-WORN SOUND PROCESSORS. THE T-COMM ALSO INCORPORATES A TELECOIL. A SWITCH ALLOWS THE USER TO SELECT BETWEEN T-MIC, TELECOIL, OR A 50/50 MIX OF THE TWO INPUTS.
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