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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 CORP.
PMA NumberP960058
Supplement NumberS047
Date Received10/27/2005
Decision Date04/11/2006
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a revision to the auria behind-the-ear sound processor, which will be marketed under the trade name auria harmony. The revision incorporates new circuitry, firmware, and components, including a new digital signal processor chip, internal telecoil, built-in diagnostic light emitting diode (led), improved audio front end, and enhanced frf transmitter.
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