Implant, Cochlear
Basic Information
- Device Name
- Implant, Cochlear
- Trade Name
- CLARION MULTI-STRATEGY COCHLEAR IMPLANT
- PMA Number
- P960058
- Device Class
- FDA Class 3
- Product Code
- MCM
- Generic Name
- Implant, cochlear
- Medical Specialty
- Unknown
- Advisory Committee
- Ear, Nose, Throat
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- June 26, 1997
- Date Received
- December 30, 1996
- Expedited Review
- N
- Docket Number
- 97M-0396
Advisory Committee 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 WITH APPROPRIATELY FITTED HEARING AIDS; 4)LACK OF BENEFIT FROM APPROPRIATELY FITTING HEARING AIDS. IN YOUNGER CHILDREN, LACK OF BENEFIT WITH HEARING AIDS IS DEFINED AS FAILURE TO ATTAIN BASIC AUDITORY MILESTONES SUCH AS A CHILD'S INCONSISTENT RESPONSE TO HIS/HER NAME IN QUIET OR TO ENVIRONMENTAL SOUNDS (MEANINGFUL AUDITORY INTEGRATION SCALE). IN OLDER CHILDREN, LACK OF AIDED BENEFIT IS DEFINED AS SCORING 0% ON OPEN-SET WORD RECOGNITION (PHONETICALLY BALANCED KINDERGARTEN TEST - WORD LIST) ADMINISTERED WITH MONITORED LIVE-VOICE (70 DB SPL). BOTH YOUNGER AND OLDER CHILDREN SHOULD DEMONSTRATE ONLY MINIMAL ABILITY ON AGE APPROPRIATE OPEN-SET SENTENCE MEASURES AND A PLATEAU IN AUDITORY DEVELOPMENT.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MCM | Implant, Cochlear | FDA class 3 | Unknown |