Project Grant R43DC021397

DETERMINING RELIABILITY AND EFFICACY OF INTRAOPERATIVE SENSORS TO REDUCE STRUCTURAL DAMAGE DURING COCHLEAR IMPLANTATION - PROJECT SUMMARY HL IS A LEADING CAUSE OF DISABILITY WORLDWIDE, RESPONSIBLE FOR AN ESTIMATED $981B IN GLOBAL COSTS. WHEN ACOUSTIC AMPLIFICATION OF HEARING AIDS IS NO LONGER AN EFFECTIVE TREATMENT, PATIENTS CAN RECEIVE A COCHLEAR IMPLANT (CI). CURRENTLY, THE SURGEON THREADS THE ELECTRODE ARRAY INTO THE SPIRAL COCHLEA, RISKING STRUCTURAL DAMAGE THAT DESTROYS RESIDUAL ACOUSTIC HEARING AND IMPACTS OVERALL HEARING OUTCOMES. CONSEQUENTLY, ADOPTION RATES REMAIN EXTREMELY LOW: 5% OF THE ELIGIBLE POPULATION IN THE US. ADVANCED OPTRONICS (AO) IS DEVELOPING A NOVEL SURGEON GUIDANCE SYSTEM USING A MICROELECTROMECHANICAL SYSTEM (MEMS) SENSOR ARRAY THAT WILL BE SEAMLESSLY INTEGRATED WITH EXISTING CI ELECTRODE ARRAY DESIGNS TO DETECT BENDING AND FORCES ACTING ON THE ARRAY TO WARN SURGEONS OF POTENTIAL RISKS. USING ADVANCED POLYMER MICROFABRICATION TECHNIQUES, AO HAS PRODUCED ULTRA-THIN AND FLEXIBLE SENSORS THAT CAN BE INCORPORATED INTO CI ELECTRODES WITH MINIMAL IMPACT ON THE CI ELECTRODE SIZE OR MECHANICS. THIS PHASE I PROPOSAL WILL DEMONSTRATE THE FEASIBILITY OF THE SYSTEM FROM A FABRICATION, USABILITY, AND REGULATORY PERSPECTIVE. THE PHASE I RESULTS WILL PAVE THE WAY FOR CLINICAL TRANSLATION DURING PHASE II. THE SPECIFIC AIMS FOR THE PHASE I PROJECT ARE: SPECIFIC AIM 1: DETERMINING SENSOR RELIABILITY WITH A COCHLEAR IMPLANT ELECTRODE: THE COMPLETE SYSTEM (CI + SENSOR) WILL BE ITERATIVELY IMPROVED FOR ROBUSTNESS AND RELIABILITY TO MAXIMIZE TWO KEY METRICS: 1. MEASUREMENT RELIABILITY, AND 2. ATTACHMENT ROBUSTNESS. SPECIFIC AIM 2: DEMONSTRATING SENSOR EFFECTIVENESS TO IMPROVE SURGEON TECHNIQUE: THE SYSTEM'S EFFICACY WILL BE VALIDATED VIA SURGEON INSERTION IN 3D PRINTED COCHLEAR MODELS. SURGEONS WILL SYSTEMATICALLY VARY INSERTION TECHNIQUE AND DATA COLLECTED IN THESE TRIALS WILL BE EVALUATED TO SHOW THAT REAL-TIME FEEDBACK ALLOWS SURGEONS TO MINIMIZE INSERTION FORCES. SPECIFIC AIM 3: DETERMINING REGULATORY PATHWAY AND REQUIREMENTS: A DETAILED REGULATORY PROPOSAL WILL BE PREPARED TO COVER INTENDED USE, REGULATORY DESCRIPTIONS OF HARDWARE AND SOFTWARE COMPONENTS, AND STUDIES TO SUPPORT SAFETY AND EFFECTIVENESS. A PRE-SUBMISSION BRIEFING DOCUMENT WILL BE PREPARED FOR AN EARLY AND COMPREHENSIVE FDA DISCUSSION ON PRODUCT DEVELOPMENT AND REGISTRATION STRATEGIES.