Study Comparing Robotic-Assisted to Manual Electrode Insertion for Cochlear Implants Evaluating Safety and Hearing Outcomes in Adults

What this Trial Is About

Researchers are comparing robotic-assisted electrode array insertion to manual insertion in cochlear implant surgery to see if the robotic method reduces trauma and improves outcomes. This study focuses on adults eligible for cochlear implants and evaluates how robotic control of insertion speed and force might preserve inner ear structures and function better than manual methods. The primary goal is to understand if this advanced technology leads to better hearing preservation and speech perception after surgery. The study involves two groups one using the FDA-approved iotaSOFT robotic insertion system and the other undergoing standard manual cochlear implant surgery. The robotic system allows precise control of insertion speed between 0.1-1.0 mmsec and reduces force variability, which has shown benefits in cadaver studies. Surgeons use a drive unit with foot pedal control to insert the electrode array carefully. The manual group receives the usual electrode insertion without robotic assistance. Participants will undergo postoperative CT scans to assess cochlear trauma, as well as evaluations of electrode impedance and auditory nerve function using ECochG and eCAP. Hearing preservation and speech perception are also measured over time. Follow-up visits occur at activation and at 3 and 6 months post-implant. This research aims to provide detailed information on structural and functional outcomes after cochlear implant surgery, helping to guide future surgical practices.

Robotic-Assisted Versus Manual Electrode Array Insertion