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A Steadier Hand: The First Human Clinical Trial of a Single-Use Robotic-Assisted Surgical Device for Cochlear Implant Electrode Array Insertion

Objective To evaluate the safety and utility of an investigational robotic-assisted cochlear implant insertion system. Study Design Prospective, single-arm, open-label study under abbreviated Investigational Device Exemption requirements. Setting All procedures were performed, and all data were collected, at a single tertiary referral center. Patients Twenty-one postlingually deafened adult subjects that met Food and Drug Administration indication criteria for cochlear implantation. Intervention All patients underwent standard-of-care surgery for unilateral cochlear implantation with the addition of a single-use robotic-assisted insertion device during cochlear electrode insertion. Main Outcome Measures Successful insertion of cochlear implant electrode array, electrode array insertion time, postoperative implant function. Results Successful robotic-assisted insertion of lateral wall cochlear implant electrode arrays was achieved in 20 (95.2%) of 21 patients. One insertion was unable to be achieved by either robotic-assisted or manual insertion methods, and the patient was retrospectively found to have a preexisting cochlear fracture. Mean intracochlear electrode array insertion time was 3 minutes 15 seconds. All implants with successful robotic-assisted electrode array insertion (n = 20) had normal impedance and neural response telemetry measures for up to 6 months after surgery. Conclusions Here we report the first human trial of a single-use robotic-assisted surgical device for cochlear implant electrode array insertion. This device successfully and safely inserted lateral wall cochlear implant electrode arrays from the three device manufacturers with devices approved but he Food and Drug Administration.