|
Device | NUCLEUS HYBRID L24 IMPLANT SYSTEM |
Generic Name | Cochlear implant with combined electrical stimulation and acoustic amplification |
Applicant | Cochlear Americas 10350 Park Meadows Drive Centennial, CO 80124 |
PMA Number | P130016 |
Supplement Number | S005 |
Date Received | 05/01/2014 |
Decision Date | 11/12/2014 |
Product Code |
PGQ |
Advisory Committee |
Ear Nose & Throat |
Clinical Trials | NCT00678899
|
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CP900 SERIES SOUND PROCESSOR FIRMWARE FEATURES AS PART OF THE NUCLEUS HYBRID L24 COCHLEAR IMPLANT SYSTEM. THESE FEATURES INCLUDE A WIND NOISE REDUCTION (WNR) ALGORITHM, A SIGNAL-TO-NOISE RATIO-BASED NOISE REDUCTION (SNR-NR) FUNCTION, AND AN AUTOMATIC ENVIRONMENTAL CLASSIFIER (SCAN) FUNCTION. |