- Device
- AURIA HARMONY HIRESOLUTION BIONIC EAR SYSTEM
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S091
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2012-04-27
- Decision code
- APPR
- Date received
- 2011-09-30
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL OF DESIGN CHANGES IMPLEMENTED IN THE APPROVED HIRES 90K COCHLEAR IMPLANT DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME "HIRES+90KR ADVANTAGE", HEREAFTER REFERRED TO AS "ADVANTAGE." THIS MODIFIED COCHLEAR IMPLANT DESIGN WILL BEMARKETED UNDER A NEW MODEL NUMBER (CI-1500-XXX) AND THE BRAND NAME FOR THE HIRES 90K COCHLEAR IMPLANT, "AURIA HARMONY HIRCSOLUTION BIONIC EAR SYSTEM" WILL BE CHANGED TO "HIRESOLUTION BIONIC EAR SYSTEM." THE ADVANTAGE IMPLANT INCLUDES THE FOLLOWING: A REINFORCED ANTENNA COIL AND AN INTEGRATED SILICONS POCKET FOR THE MAGNET. THE IMPLANT DIGITAL INTEGRATED CIRCUIT HAS ALSO BEEN REVISED TO INCLUDE THE LATEST WAFER ASSEMBLY PROCESSES.