PMA P970051S123

Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Applicant: Cochlear Americas
PMA number: P970051
Supplement: S123
Product code: MCM
Decision date: 2015-04-02
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR NEW DIGITAL SOUND PROCESSOR FIRMWARE FEATURES AS PART OF THE COCHLEAR NUCLEUS 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 24 COCHLEAR IMPLANT SYSTEM
Applicant: Cochlear Americas
PMA number: P970051
Supplement: S123
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2015-04-02
Decision code: APPR
Date received: 2014-10-02
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR NEW DIGITAL SOUND PROCESSOR FIRMWARE FEATURES AS PART OF THE COCHLEAR NUCLEUS 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.