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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMULTI-STRATEGY COCHLEAR IMPLANT-PLATINUM BTE SOUND PROCESSOR (ADULT)
Generic NameImplant, cochlear
ApplicantADVANCED BIONICS CORP.
12740 SAN FERNANDO RD.
SYLMAR, CA 91342
PMA NumberP940022
Supplement NumberS016
Date Received11/16/2000
Decision Date01/12/2001
APCB Date 10/18/2002
Product Code MCM 
Advisory Committee Ear Nose & Throat
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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 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. ADULTS: 1) 18 YEARS OF AGE OR OLDER 2) PROFOUND, BILATERAL SENSORINEURAL DEAFNESS (>=90DB) 3) POSTLINGUALLY DEAFENED 4) LACK OF BENEFIT FROM APPROPRIATELY FITTED HEARING AIDS.
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