CLARION MULTI-STRATEGY COCHLEAR IMPLANT
FDA premarket approval P960058 · decided 1997-06-26
Approval details
- PMA number
- P960058
- Trade name
- CLARION MULTI-STRATEGY COCHLEAR IMPLANT
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics
- Date received
- 1996-12-30
- Decision date
- 1997-06-26
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- APPROVAL FOR THE CLARION MULTI-STRATEGY COCHLEAR IMPLANT. THE DEVICE IS INTENDED TO RESTORE A LEVEL OF AUDITORY SENSATION TO CHILDREN WITH PROFOUND SENSORINEURAL DEAFNESS VIA ELECTRICAL STIMULATION OF THE AUDITORY NERVE. CLARION IS INDICATED FOR THE FOLLOWING: 1)CHILDREN, 2 THROUGH 17 YEARS OF AGE. IF X-RAYS DEMONSTRATE EVIDENCE OF OSSIFICATION, CHILDREN AS YOUNG AS 18 MONTHS MAY BE IMPLANTED; 2)PROFOUND, BILATERAL SENSORINEURAL DEAFNESS; 3)UNDERGONE OR BE WILLING TO UNDERGO A HEARING AID TRAIL
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