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.
| Device | NUCLEUS ABI541 AUDITORY BRAINSTEM IMPLANT |
| Classification Name | Implant, Auditory Brainstem |
| Generic Name | Implant, Auditory Brainstem |
| Applicant | Cochlear Americas |
| Date Received | 2015-12-18 |
| Decision Date | 2016-06-13 |
| PMA | P000015 |
| Supplement | S012 |
| Product Code | MHE |
| Advisory Committee | Ear Nose & Throat |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Cochlear Americas 13059 East Peakview Avenue centennial, CO 80111 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P000015 | | Original Filing |
| S048 |
2022-09-07 |
Real-time Process |
| S047 |
2022-04-26 |
Normal 180 Day Track |
| S046 |
2021-06-21 |
135 Review Track For 30-day Notice |
| S045 |
2020-11-12 |
30-day Notice |
| S044 | | |
| S043 |
2020-07-15 |
30-day Notice |
| S042 |
2019-11-13 |
30-day Notice |
| S041 | | |
| S040 | | |
| S039 |
2019-07-31 |
30-day Notice |
| S038 | | |
| S037 |
2019-06-06 |
30-day Notice |
| S036 | | |
| S035 |
2019-01-30 |
30-day Notice |
| S034 |
2018-11-01 |
Normal 180 Day Track |
| S033 |
2018-08-13 |
30-day Notice |
| S032 |
2018-04-13 |
30-day Notice |
| S031 |
2018-02-15 |
30-day Notice |
| S030 |
2018-02-02 |
30-day Notice |
| S029 |
2018-01-02 |
30-day Notice |
| S028 |
2018-01-02 |
30-day Notice |
| S027 |
2017-11-13 |
Normal 180 Day Track |
| S026 |
2017-08-25 |
135 Review Track For 30-day Notice |
| S025 |
2017-08-07 |
30-day Notice |
| S024 |
2017-07-26 |
30-day Notice |
| S023 |
2017-06-21 |
Real-time Process |
| S022 |
2017-06-07 |
30-day Notice |
| S021 |
2017-05-16 |
30-day Notice |
| S020 |
2017-04-10 |
30-day Notice |
| S019 |
2017-03-23 |
30-day Notice |
| S018 |
2016-11-23 |
30-day Notice |
| S017 |
2016-11-23 |
30-day Notice |
| S016 |
2016-10-12 |
Normal 180 Day Track |
| S015 |
2016-09-22 |
30-day Notice |
| S014 |
2016-06-23 |
30-day Notice |
| S013 | | |
| S012 |
2015-12-18 |
Normal 180 Day Track |
| S011 |
2009-10-13 |
Special (immediate Track) |
| S010 |
2007-12-03 |
Real-time Process |
| S009 | | |
| S008 |
2006-09-05 |
30-day Notice |
| S007 | | |
| S006 |
2005-03-09 |
30-day Notice |
| S005 |
2003-06-24 |
Real-time Process |
| S004 |
2002-12-06 |
Normal 180 Day Track |
| S003 |
2002-10-31 |
Normal 180 Day Track |
| S002 |
2001-07-23 |
Normal 180 Day Track |
| S001 |
2001-06-22 |
Normal 180 Day Track |
NIH GUDID Devices