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

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Abstract: While the Cochlear Implant (CI) has traditionally been used to treat patients with severe to complete hearing loss, recent advances have now made the CI a treatment option for people with moderate hearing levels who previously did not qualify for a traditional CI. These hearing preservation approaches attempt to preserve the patient's residual hearing following CI surgery. However, studies have suggested that trauma to the cochlea during electrode insertion results in damage to delicate inner ear structures, and up to 50% of patients experience delayed hearing loss following surgery that results in a diminished quality of life.1 Additionally, recent studies suggest that trauma to the cochlea occurring during electrode insertion may be correlated with changes in Electrocochleography (ECochG) readings taken from the cochlea. In this SBIR, iotaMotion aims to develop an insertion tool that couples cochlear implant ECochG measurements to a micromechanical control system that will assist the surgeon to sense, predict, and mitigate cochlear insertion trauma in real-time during electrode insertion. The anticipated impact of this technology will be to improve short and long-term hearing outcomes for CI patients by enhancing “hearing preservation” cochlear implantation. The project will develop a functional prototype with insertion control algorithms for a “smart” insertion tool and then evaluate the system's feasibility in a pilot animal study via the following three aims:1) Develop a Working Benchtop Prototype of a Real-Time Intracochlear Damage Monitoring and Insertion Tool. The first stage of development will comprise the design, fabrication, and testing of the device in a laboratory setting; demonstrating that the insertion tool can be controlled and regulated by the novel hardware and software inputs. 2) Evaluate the control system EcochG feedback sensitivity and reliability with motion control algorithms that utilize real-time feedback to prevent intracochlear damage. Aim 2 will develop several firmware control algorithms that detect ECochG changes with a feedback loop to the control console and motor unit for micromechanical motion adjustments. This will help determine the relationship between ECochG readings and electrode movement within the cochlea. 3) Demonstrate proof of concept capability to assist the surgeon during electrode insertion based on real time ECochG feedback in pilot large animal study. The final specific aim will evaluate the prototype device in vivo with a pilot animal model. The ability of the device to sense and mitigate ECochG changes through motion adjustments will be validated. Ultimately, the success of Phase I will allow development of this insertion system to progress to a second iteration of the design (based on the knowledge gained in Phase I) and further in vivo testing to establish the efficacy of the device as compared to the current gold standard of implantations. SBIR funding will help secure additional outside investment and bring us closer to commercializing this much needed treatment for people suffering from disabling hearing loss.