PMA P000015S012

Device: NUCLEUS ABI541 AUDITORY BRAINSTEM IMPLANT
Applicant: Cochlear Americas
PMA number: P000015
Supplement: S012
Product code: MHE
Decision date: 2016-06-13
Classification: Implant, Auditory Brainstem
Generic name: Implant, auditory brainstem
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.

Current openFDA PMA Record#

Device: NUCLEUS ABI541 AUDITORY BRAINSTEM IMPLANT
Applicant: Cochlear Americas
PMA number: P000015
Supplement: S012
Product code: MHE
Generic name: Implant, auditory brainstem
Decision date: 2016-06-13
Decision code: APPR
Date received: 2015-12-18
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
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.