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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 NameHARMONY HIRESOLUTION BIONIC EAR SYSTEM
Classification Nameimplant, cochlear
Generic Namecochlear implant
ApplicantADVANCED BIONICS CORP.
PMA NumberP960058
Supplement NumberS094
Date Received11/02/2011
Decision Date04/02/2012
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 new accessory, called t -comm, for advanced bionics body-worn sound processors. This accessory allows the use of the currently-approved t-mic to be used with the body-worn sound processors. The t-comm also incorporates a telecoil. A switch allows the user to select between t-mic, telecoil, or a 50/50 mix of the two inputs.
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