DEVICE EVALUATION SUMMARY: TEST RESULTS FROM DEVICE MANUFACTURING WERE REVIEWED. SOUND PROCESSOR (SN (B)(4)) PASSED ALL FUNCTIONAL TESTING IN PRODUCTION. A DHR REVIEW REVEALED THAT THE DEVICE MET ALL SPECIFICATIONS AND THERE WERE NO MANUFACTURING ISSUES. THE SOUND PROCESSOR (SN (B)(4)) WAS EVALUATED UPON RECEIPT AT ENVOY MEDICAL. A VISUAL INSPECTION REVEALED NO DEVICE ABNORMALITIES EXCEPT FOR SOME SURFACE SCUFFING CONSISTENT WITH THE USE OF TOOLS FOR REMOVAL. THE BATTERY'S VOLTAGE WAS TESTED AND CONFIRMED TO BE DEPLETED. THE BATTERY WAS CONFIRMED TO BE DEPLETED AT THE TIME OF EXPLANT. ROOT CAUSE FINDINGS INDICATE THAT PATIENT WAS PROGRAMMED IN SETTINGS THAT RESULT IN FREQUENT OR PERPETUAL FEEDBACK WITHOUT PATIENT ABLE TO HEAR IT (PROFOUND HIGH FREQUENCY HEARING LOSS). (B)(4).
D
Patient 1
ENVOY MEDICAL WAS NOTIFIED OF A SOUND PROCESSOR REPLACEMENT DUE TO BATTERY DEPLETION. THIS PARTICULAR SOUND PROCESSOR WAS IMPLANTED FOR 2.1 YEARS, WHICH IS LESS THAN THE EXPECTED WORST CASE BATTERY LIFE FOR NORMAL OPERATION OF 2.8 YEARS. CLINICAL HISTORY: (B)(6) 2011 - ORIGINAL IMPLANT, (B)(6) 2011 - FITTING, (B)(6) 2013 - FITTING, (B)(6) 2013 - ANALYSIS, (B)(6) 2013 - BATTERY REPLACEMENT. ON (B)(6) 2016 - ROOT CAUSE FINDINGS INDICATE THAT PATIENT WAS PROGRAMMED IN SETTINGS THAT RESULT IN FREQUENT OR PERPETUAL FEEDBACK WITHOUT PATIENT ABLE TO HEAR IT (PROFOUND HIGH FREQUENCY HEARING LOSS). KNOWN ISSUE CONTRIBUTING TO EARLY BATTERY DEPLETION.