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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceNUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM
Generic NameImplant, auditory brainstem
ApplicantCochlear Americas
10350 Park Meadows Drive
Lone Tree, CO 80124
PMA NumberP000015
Date Received03/29/2000
Decision Date10/20/2000
Product Code MHE 
Docket Number 00M-1659
Notice Date 12/12/2000
Advisory Committee Ear Nose & Throat
Expedited Review Granted? Yes
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT (ABI) SYSTEM, WHICH IS INTENDED TO RESTORE USEFUL HEARING VIA ELECTRICAL STIMULATION OF THE COCHLEAR NUCLEUS. THE DEVICE IS INDICATED FOR INDIVIDUALS 12 YEARS OF AGE OR OLDER, WHO HAVE BEEN DIAGNOSED WITH NEUROFIBROMATOSIS TYPE 2 (NF2). IMPLANTATION MAY OCCUR DURING FIRST OR SECOND-SIDE TUMOR REMOVAL, OR IN PATIENTS WITH PREVIOUSLY REMOVED ACOUSTIC TUMORS BILATERALLY. BECAUSE THE SURGICAL PROCEDURE FOR TUMOR EXCISION AND ELECTRODE PLACEMENT ELIMINATES RESIDUAL HEARING, PREOPERATIVE AUDIOLOGICAL CRITERIA ARE NOT RELEVANT. PROSPECTIVE IMPLANT RECIPIENTS AND THEIR FAMILIES SHOULD HAVE APPROPRIATE EXPECTATIONS, REGARDING THE POTENTIAL BENEFITS OF AN AUDITORY BRAINSTEM IMPLANT AND SHOULD BE HIGHLY MOTIVATED TO PARTICIPATE IN THE POSTOPEARATIVE REHABILITATION PROCESS.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S008 S010 S011 S012 S014 
S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 S025 S026 
S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 S037 S038 
S039 S040 S041 S042 S043 S044 S045 S046 S047 S048 S049 S050 
S051 S052 
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