| 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. |
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| Device | HARMONY HIRESOLUTION BIONIC EAR SYSTEM |
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| Classification Name | implant, cochlear |
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| Generic Name | implant, cochlear |
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| Applicant |
| ADVANCED BIONICS |
| 28515 westinghouse place |
| valencia, CA 91355 |
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| PMA Number | P960058 |
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| Supplement Number | S049 |
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| Date Received | 12/12/2005 |
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| Decision Date | 08/17/2006 |
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| Product Code | |
| Advisory Committee |
Ear Nose & Throat |
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| Supplement Type | normal 180 day track |
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| Supplement Reason | change design/components/specifications/material |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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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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