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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.
 
DeviceNUCLEUS ABI541 AUDITORY BRAINSTEM IMPLANT
Generic NameImplant, auditory brainstem
ApplicantCochlear Americas
10350 Park Meadows Drive
Lone Tree, CO 80124
PMA NumberP000015
Supplement NumberS012
Date Received12/18/2015
Decision Date06/13/2016
Product Code MHE 
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 the Nucleus ABI541 Auditory Brainstem Implant, a modification to the existing ABI24M device, which is intended to restore a level of auditory sensation via electrical stimulation of the cochlear nucleus in 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. This supplement also requested approval for a new bodyworn battery pack compatible with the Nucleus 6 Sound Processor, and the ability to program ABI541 recipients using the Advanced Combination Encoder (ACE) sound coding strategy.
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