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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.
 
Trade NameHIRESOLUTION BIONIC EAR SYSTEM
Classification Nameimplant, cochlear
Generic Namecochlear implant
ApplicantADVANCED BIONICS LLC
PMA NumberP960058
Supplement NumberS100
Date Received11/28/2012
Decision Date03/12/2013
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Clinical Trials NCT01616576
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the hires optima sound processing strategy. Hires optima is a modification of the hires fidelity 120 strategy, and is intended to optimize power efficiency. This new strategy improves battery life without compromising the listening benefits of the hiresolution bionic ear system.
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