HIRESOLUTION BIONIC EAR SYSTEM WITH NAIDA CI Q70 SOUND PROCESSOR
FDA premarket approval P960058/S102 · decided 2013-08-19
Approval details
- PMA number
- P960058
- Supplement
- S102
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HIRESOLUTION BIONIC EAR SYSTEM WITH NAIDA CI Q70 SOUND PROCESSOR
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics
- Date received
- 2013-02-04
- Decision date
- 2013-08-19
- Days to decision
- 196 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- APPROVAL FOR THE NAIDA CI Q70 SOUND PROCESSOR, A SMALLER BEHIND THE EAR (BTE) SOUND PROCESSOR THAT HAS WIRELESS CONNECTIVITY. THE SUPPLEMENT ALSO INCLUDES A COMPLEMENTARY SET OF ACCESSORIES, A NEW CLINICIANS PROGRAMMING INTERFACE, AND A NEW VERSION OF THE SOUNDWAVE FITTING SOFTWARE.
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