Approval for neuro cochlear implant system (ncis)the neuro cochlear implant system (ncis) is indicated for individuals eighteen (18) years of age or older, with bilateral severe-to-profound sensorineural hearing loss, who obtain limited benefit from appropriately fitted hearing aid(s). Severe-to-profound hearing loss is determined by a pure-tone average (pta) superior or equal (? ) to 70 db hl at 500, 1000 and 2000 hz. Limited benefit from amplification is defined by scores of 50% or less on hearing in noise test (hint) sentences in quiet or noise, in the best-aided listening condition. Unless already appropriately fitted with hearing aids, it is recommended that candidates undergo a hearing aid trial period of three (3) months.
| Device | Neuro Cochlear Implant System |
| Generic Name | Implant, Cochlear |
| Applicant | Oticon Medical |
| Date Received | 2020-03-23 |
| Decision Date | 2021-06-23 |
| PMA | P200021 |
| Supplement | S |
| Product Code | MCM |
| Advisory Committee | Ear Nose & Throat |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Oticon Medical 2720 Chemin Saint Bernard vallauris 06220 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P200021 | Original Filing | |
| S014 | 2022-05-18 | 30-day Notice |
| S013 | ||
| S012 | 2022-04-29 | Normal 180 Day Track No User Fee |
| S011 | 2022-02-23 | 30-day Notice |
| S010 | 2021-12-15 | Normal 180 Day Track No User Fee |
| S009 | 2021-10-08 | 30-day Notice |
| S008 | ||
| S007 | 2021-09-27 | 30-day Notice |
| S006 | 2021-09-27 | 30-day Notice |
| S005 | 2021-08-23 | 30-day Notice |
| S004 | 2021-08-11 | 30-day Notice |
| S003 | 2021-08-11 | 30-day Notice |
| S002 | ||
| S001 | 2021-07-23 | Normal 180 Day Track No User Fee |