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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namehybrid cochlear implant
PMA NumberP130016
Supplement NumberS005
Date Received05/01/2014
Decision Date11/12/2014
Product Code
PGQ[ Registered Establishments with PGQ ]
Advisory Committee Ear Nose & Throat
Clinical Trials NCT00678899
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
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.