PMA P130016S005
- Device
- NUCLEUS HYBRID L24 IMPLANT SYSTEM
- Applicant
- Cochlear Americas
- PMA number
- P130016
- Supplement
- S005
- Product code
- PGQ
- Decision date
- 2014-11-12
- Classification
- Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- 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.
Current openFDA PMA Record#
- Device
- NUCLEUS HYBRID L24 IMPLANT SYSTEM
- Applicant
- Cochlear Americas
- PMA number
- P130016
- Supplement
- S005
- Product code
- PGQ
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Decision date
- 2014-11-12
- Decision code
- APPR
- Date received
- 2014-05-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- 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.