Approval for the nucleus® hybrid l24 cochlear implant system. The nucleus® hybrid l24 cochlear implant system is intended to provide electric stimulation to the mid-to-high frequency region of the cochlea and acoustic amplification to the low frequency regions, for patients with residual low frequency hearing sensitivity. The system is indicated for unilateral use in patients aged 18 years and older who have residuallow-frequency hearing sensitivity and severe to profound high frequency sensorineural hearing loss, and who obtain limited benefit from appropriately fit bilateral hearing aids. Typical preoperative hearing of candidates ranges from normal to moderate hearing loss in the low frequencies (thresholds no poorer than 60 db hl up to and including 500 hz), with severe to profound mid to high frequency hearing loss (threshold average of 2000, 3000, and 4000 hz >=75 db hl) in the ear to be implanted, and moderately severe to profound mid to high frequency hearing loss (threshold average of 2000, 3000, and 4000 hz >=60 db hl) in the contralateral ear. The cnc word recognition score will be between 10% and 60%, inclusively, in the ear to be implanted in the preoperative aided condition and in the contralateral ear will be equal to or better than that of the ear to be implanted but not more than 80% correct. Prospective candidates shouldgo through a suitable hearing aid trial, unless already appropriately fit with hearing aids.
| Device | NUCLEUS HYBRID L24 IMPLANT SYSTEM |
| Classification Name | Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification |
| Generic Name | Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification |
| Applicant | Cochlear Americas |
| Date Received | 2013-06-03 |
| Decision Date | 2014-03-20 |
| Notice Date | 2014-04-10 |
| PMA | P130016 |
| Supplement | S |
| Product Code | PGQ |
| Docket Number | 14M-0327 |
| Advisory Committee | Ear Nose & Throat |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | Cochlear Americas 13059 East Peakview Avenue centennial, CO 80111 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P130016 | | Original Filing |
| S051 |
2022-09-07 |
Real-time Process |
| S050 |
2022-07-11 |
30-day Notice |
| S049 |
2022-05-02 |
Normal 180 Day Track No User Fee |
| S048 | | |
| S047 |
2022-02-01 |
30-day Notice |
| S046 | | |
| S045 |
2020-11-12 |
30-day Notice |
| S044 | | |
| S043 |
2020-01-14 |
Special (immediate Track) |
| S042 | | |
| S041 | | |
| S040 | | |
| S039 | | |
| S038 |
2019-06-07 |
Normal 180 Day Track No User Fee |
| S037 |
2019-01-30 |
30-day Notice |
| S036 |
2018-11-01 |
Normal 180 Day Track |
| S035 |
2018-08-13 |
30-day Notice |
| S034 |
2018-02-15 |
30-day Notice |
| S033 |
2018-01-02 |
30-day Notice |
| S032 |
2017-11-13 |
Normal 180 Day Track |
| S031 |
2017-07-17 |
30-day Notice |
| S030 |
2017-06-21 |
Real-time Process |
| S029 |
2017-06-07 |
30-day Notice |
| S028 |
2017-05-23 |
Normal 180 Day Track |
| S027 |
2017-05-16 |
30-day Notice |
| S026 |
2017-04-24 |
30-day Notice |
| S025 |
2017-04-10 |
30-day Notice |
| S024 |
2017-03-23 |
30-day Notice |
| S023 |
2017-02-27 |
30-day Notice |
| S022 |
2016-10-12 |
Normal 180 Day Track |
| S021 |
2016-10-06 |
Normal 180 Day Track No User Fee |
| S020 |
2016-07-25 |
30-day Notice |
| S019 |
2016-06-15 |
135 Review Track For 30-day Notice |
| S018 |
2016-02-24 |
30-day Notice |
| S017 |
2016-02-24 |
Normal 180 Day Track |
| S016 |
2016-02-08 |
Normal 180 Day Track |
| S015 |
2016-01-06 |
30-day Notice |
| S014 |
2016-01-05 |
30-day Notice |
| S013 |
2015-12-04 |
30-day Notice |
| S012 |
2015-11-23 |
Normal 180 Day Track |
| S011 |
2015-02-13 |
30-day Notice |
| S010 |
2014-12-24 |
30-day Notice |
| S009 |
2014-09-24 |
Normal 180 Day Track No User Fee |
| S008 |
2014-07-23 |
30-day Notice |
| S007 |
2014-06-09 |
Real-time Process |
| S006 |
2014-05-16 |
30-day Notice |
| S005 |
2014-05-01 |
Normal 180 Day Track |
| S004 |
2014-04-18 |
Normal 180 Day Track No User Fee |
| S003 |
2014-04-18 |
Normal 180 Day Track No User Fee |
| S002 |
2014-04-02 |
Real-time Process |
| S001 |
2014-03-28 |
30-day Notice |
NIH GUDID Devices