FDA.reportPublic FDA data

PMA P960058S015

Device
MULTI-STRATEGY COCHLEAR IMPLANT-PLATINUM BTE SOUND PROCESSOR (PEDIATRIC)
Applicant
Advanced Bionics
PMA number
P960058
Supplement
S015
Product code
MCM
Decision date
2001-01-12
Classification
Implant, Cochlear
Generic name
Implant, cochlear
Approval order statement
APPROVAL FOR INCORPORATION OF THE SIZE-REDUCED SPEECH PROCESSOR TO BE WORN BEHIND THE EAR, KNOWN AS THE PLATINUM BTE(TM) SOUND PROCESSOR. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CLARION(R) MULTI-STRATEGY COCHLEAR IMPLANT PLATINUM BTE(TM) SOUND PROCESSOR. THE DEVICE IS INDICATED TO RESTORE A LEVEL OF AUDITORY SENSATION TO INDIVIDUALS WITH PROFOUND SENSORINEURAL DEAFNESS VIA ELECTRICAL STIMULATION OF THE AUDITORY NERVE. CHILDREN: 1) TWO YEARS OF AGE THROUGH 17 YEARS, IF X-RAYS DEMONSTRATE EVIDENCE OF OSSIFICATION, CHILDREN AS YOUND AS 18 MONTHS MAY BE IMPLANTED. 2) PROFOUND, BILATERAL SENSORINEURAL DEAFNESS (>=90DB) 3) UNDERGONE OR BE WILLING TO UNDERGO A HEARING ADI TRIAL WITH APPROPRIATELY FITTED HEARING AIDS 4) LACK OF BENEFIT FROM APPROPRIATELY FITTED HEARING AIDS. IN YOUNGER CHILDREN, LACK OF BENEFIT WITH HEARING AIDS IS DEFINED AS FAILURE TO ATTAIN BASIC AUDITORY MILESTONES WUCH AS A CHILD'S INCONSISTENT RESPONSE TO HIS/HER NAME ION QUIET OR TO ENVIRONMENTAL SOUNDS (MEANINGFUL AUDITORY INTEGRATION SCALE). IN OLDER CHILDREN, LACK OF AIDED BENEFIT IS DEFINED AS SCORING 0% ON OPEN-SET WORK 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.

Current openFDA PMA Record#

Device
MULTI-STRATEGY COCHLEAR IMPLANT-PLATINUM BTE SOUND PROCESSOR (PEDIATRIC)
Applicant
Advanced Bionics
PMA number
P960058
Supplement
S015
Product code
MCM
Generic name
Implant, cochlear
Decision date
2001-01-12
Decision code
APPR
Date received
2000-11-16
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR INCORPORATION OF THE SIZE-REDUCED SPEECH PROCESSOR TO BE WORN BEHIND THE EAR, KNOWN AS THE PLATINUM BTE(TM) SOUND PROCESSOR. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CLARION(R) MULTI-STRATEGY COCHLEAR IMPLANT PLATINUM BTE(TM) SOUND PROCESSOR. THE DEVICE IS INDICATED TO RESTORE A LEVEL OF AUDITORY SENSATION TO INDIVIDUALS WITH PROFOUND SENSORINEURAL DEAFNESS VIA ELECTRICAL STIMULATION OF THE AUDITORY NERVE. CHILDREN: 1) TWO YEARS OF AGE THROUGH 17 YEARS, IF X-RAYS DEMONSTRATE EVIDENCE OF OSSIFICATION, CHILDREN AS YOUND AS 18 MONTHS MAY BE IMPLANTED. 2) PROFOUND, BILATERAL SENSORINEURAL DEAFNESS (>=90DB) 3) UNDERGONE OR BE WILLING TO UNDERGO A HEARING ADI TRIAL WITH APPROPRIATELY FITTED HEARING AIDS 4) LACK OF BENEFIT FROM APPROPRIATELY FITTED HEARING AIDS. IN YOUNGER CHILDREN, LACK OF BENEFIT WITH HEARING AIDS IS DEFINED AS FAILURE TO ATTAIN BASIC AUDITORY MILESTONES WUCH AS A CHILD'S INCONSISTENT RESPONSE TO HIS/HER NAME ION QUIET OR TO ENVIRONMENTAL SOUNDS (MEANINGFUL AUDITORY INTEGRATION SCALE). IN OLDER CHILDREN, LACK OF AIDED BENEFIT IS DEFINED AS SCORING 0% ON OPEN-SET WORK 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.