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

摘要

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.