Robotic-Assisted Versus Manual Electrode Array Insertion

Robotics-assisted electrode insertion overcomes many surgeon-related kinetic limitations such as insertion speed, tremor, drift, and lack of accurate force control. In human cadaveric cochleae, robotics-assisted electrode insertion causes less intracochlear trauma compared to manual insertion. Whether this technical advance results in functional benefits in CI patients remains unknown. To address this critical knowledge gap, the investigators will compare cochlear trauma assessed using CT scans, cochlear and AN function assessed using ECochG and/or the eCAP, and clinical outcomes quantified by postoperative residual acoustic hearing and speech perception scores between participants randomized to either manual or robotics-assisted electrode array insertion.

NCT Number	NCT06951594
Lead Sponsor	University of Iowa
Conditions	Cochlear Implantation, Robotics
Enrollment	100 participants
Start Date	2025-06-30
Primary Completion	2028-03-31 (estimated)
Study Completion	2028-08-31 (estimated)
Updated on ClinicalTrials.gov	2025-07-17