Development of a Micro-Mechanical Insertion Tool with Intraoperative Real-Time Electrophysiological Sensing Control for Cochlear Implantation

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Project Summary/Abstract. One of the more recent goals of cochlear implant (CI) surgery is the preservation of residual hearing to improve overall patient outcomes. Unfortunately, up to 50% of patients experience delayed residual hearing loss following cochlear implant surgery, resulting in a diminished quality of life. To address this issue, iotaMotion is developing an insertion system to assist surgeons in performing controlled and consistent CI electrode insertions as well as to monitor the electrocochleography (ECochG) readings taken from the cochlea during CI electrode insertion, which have been shown to indicate cellular damage and residual hearing loss. The system controls the rate of electrode array insertion and responds in real time to ECochG feedback received from the cochlear tissues via a feedback loop. In Phase I, a working benchtop prototype was developed and the system response to ECochG signals was demonstrated in both benchtop and large animal in vivo proof-of-concept studies. Control algorithms were also developed as part of the feedback loop to the insertion system’s motor unit. Continuing with these results, the goals of this proposed Phase II SBIR project are to: 1) Improve System Usability and Enhance Use Features. With the goal of continuing to improve the prototype developed in Phase I, Aim 1 work will improve system fidelity, incorporate real-time impedance checks, integrate the system into an easy-to-use tablet for use in the OR, and evaluate usability. 2) Establish Manufacturing and Quality Controls. The supply chain and manufacturing and quality procedures to verify/validate system safety and reliability will be implemented using relevant standards and FDA guidance to define testing procedures. The electrical safety, sterility, biocompatibility, functionality, and data security testing of production-level devices that will be used for pre-clinical studies and commercialization will be performed. 3) Evaluate In Vivo Efficacy of the Combined System. The system will be evaluated in an acute in vivo model of cochlear implantation. By comparing usage of the system to the current gold standard of manual CI electrode insertions, iotaMotion will evaluate the system’s ability to monitor ECochG signals from the cochlea and will confirm that the system induces no increases in scalar translocations or OSL fractures when compared to manual insertions as assessed by 3D X-ray microscopy. 4) Perform Observational Clinical Study. As part of the regulatory strategy, the ability of the ECochG monitoring system to collect reliable and significant ECochG signals in an observational clinical study will be evaluated. Completion of these Phase II Aims will set the stage for the development and production of the system in a GMP environment and execution of a prospective clinical trial designed to establish safety and efficacy in humans. We envision the data collected to comprise the basis for the Device History Record that will be used to prepare for first-in-man studies. This Phase II funding will help secure additional company investment and will move us much closer to commercializing this much-needed treatment for people suffering from disabling hearing loss.