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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceHARMONY HIRESOLUTION BIONIC EAR SYSTEM
Generic Nameimplant, cochlear
ApplicantADVANCED BIONICS
28515 westinghouse place
valencia, CA 91355
PMA NumberP960058
Supplement NumberS049
Date Received12/12/2005
Decision Date08/17/2006
Product Code MCM 
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A MODIFICATION TO THE SOUNDWAVE PROFESSIONAL SUITE SOFTWARE (SOUNDWAVE VERSION 1.4) WHICH IMPLEMENTS AN OPTIONAL FEATURE, KNOWN AS FIDELITY 120, AND ADDS SUPPORT FOR THE AURIA HARMONY SOUND PROCESSOR. THE SOFTWARE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SOUNDWAVE PROFESSIONAL SUITE VERSION 1.4 AND IS INDICATED FOR ADULT PATIENTS AND PEDIATRIC PATIENTS AGED 12-MONTHS THROUGH 17 YEARS, 11-MONTHS. HOWEVER, THE OPTIONAL SOFTWARE CAPABILITY KNOWN AS FIDELITY 120 (SPEECH ENCODING STRATEGY) IS LIMITED FOR USE IN ADULTS WITH 1) POST-LINGUAL ONSET OF SEVERE OR PROFOUND HEARING LOSS, 2) A MINIMUM OF THREE-MONTHS EXPERIENCE WITH STANDARD HIRES, AND 3) WHO HAVE THE COGNITIVE ABILITY TO CHOOSE THE SOUND PROCESSING OPTIONS.
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