Description of Event or Problem · 0
I AM A RECIPIENT OF THE ADVANCED BIONICS C1 INTERNAL COCHLEAR IMPLANT, WHICH I RECEIVED IN THE LATE 1990S. MY ONLY COMPATIBLE EXTERNAL PROCESSOR WAS RELEASED IN 2019, AND THERE ARE NO CURRENT OR PLANNED UPGRADES OR BACKWARD COMPATIBLE OPTIONS AVAILABLE. I WAS INFORMED DIRECTLY BY THE CEO OF ADVANCED BIONICS THAT THERE ARE NO COMPATIBLE PROCESSORS IN DEVELOPMENT. THIS CONTRADICTS THE PROMISE OF BACKWARD COMPATIBILITY THAT WAS MADE TO MY PARENTS WHEN I RECEIVED THE IMPLANT WHEN I WAS 2 YEARS OLD. I HAVE SENT TWO FOLLOW-UP EMAILS TO THE CHIEF EXECUTIVE OFFICER ASKING WHETHER THERE ARE ANY ACTIVE RESEARCH EFFORTS, A DEVELOPMENT ROADMAP, OR PLANS FOR A FUTURE C1-COMPATIBLE PROCESSOR -- I HAVE RECEIVED NO RESPONSE. IF MY PROCESSOR FAILS, I FACE THE RISK OF COMPLETE HEARING LOSS. I HAVE CONSULTED MULTIPLE SURGEONS AND AUDIOLOGISTS (2¿3 PROFESSIONALS), ALL OF WHOM STRONGLY ADVISED AGAINST ELECTIVE REIMPLANTATION SURGERY DUE TO THE RISKS INVOLVED---UNLESS THE INTERNAL DEVICE ITSELF FAILS. I FEEL BACKED INTO A CORNER WITH NO SAFE OR MODERN SOLUTION TO MAINTAIN ACCESS TO HEARING. I'VE ALSO SPOKEN WITH A REPRESENTATIVE FROM COCHLEAR AMERICAS, WHO CONFIRMED THAT PATIENTS WITH INTERNAL IMPLANTS DATING BACK TO THE MID TO LATE 1990S STILL HAVE BACKWARD-COMPATIBLE PROCESSOR OPTIONS TODAY. I KNOW SEVERAL PATIENTS USING COCHLEAR DEVICES WHO CONTINUE TO RECEIVE MODERN UPGRADES. THIS MAKES IT DIFFICULT TO UNDERSTAND WHY ADVANCED BIONICS, A WELL-FUNDED COMPANY, HAS POSSIBLY ABANDONED C1 USERS ENTIRELY. I AM REPORTING THIS ISSUE TO RAISE AWARENESS ABOUT THE LACK OF SUPPORT AND BACKWARD COMPATIBILITY FOR C1 RECIPIENTS, AND THE RISK IT POSES TO HEARING HEALTH, MEDICAL EQUITY, AND PATIENT SAFETY. I AM ASKING THE FDA TO INVESTIGATE OR ADDRESS THIS CONCERN, ESPECIALLY AS IT RELATES TO LONG-TERM RECIPIENTS OF A CLASS III MEDICAL DEVICE BEING LEFT WITHOUT ACCESS OR RECOURSE. REFERENCE REPORT: MW5175285.