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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Nameimplant, auditory brainstem
Generic Nameimplant, auditory brainstem
Cochlear Americas
13059 east peakview avenue
centennial, CO 80111
PMA NumberP000015
Date Received03/29/2000
Decision Date10/20/2000
Product Code
MHE[ Registered Establishments with MHE ]
Docket Number 00M-1659
Notice Date 12/12/2000
Advisory Committee Ear Nose & Throat
Expedited Review Granted? Yes
Combination Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S008 S010 S011 
S012 S014 S015