CLARION CII BIONIC EAR SYSTEM
FDA premarket approval P960058/S023 · decided 2002-09-09
Approval details
- PMA number
- P960058
- Supplement
- S023
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CLARION CII BIONIC EAR SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics
- Date received
- 2002-07-29
- Decision date
- 2002-09-09
- Days to decision
- 42 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- APPROVAL FOR THE COMMERCIAL DISTRIBUTION OF THE CLARION HIFOCUS ELECTRODE WITHOUT THE POSITIONER (MODEL AB-5100-11A) IN ADULTS WITH POST-LINGUAL ONSET OF SEVERE-TO-PROFOUND HEARING LOSS AND IN CHILDREN WITH PROFOUND HEARING LOSS (12-MONTHS TO 17-YEARS, 11-MONTHS OF AGE). IT ALSO REQUESTED APPROVAL OF THE HIGH RESOLUTION SPEECH PROCESSING STRATEGY (HIRES SOFTWARE, MODEL NUMBER CI-6055) FOR BOTH PATIENT POPULATIONS.
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