Comparative Analysis of Hearing Outcomes: Robotic vs. Manual Insertion of Cochlear Implants

This research study is evaluating two different methods of cochlear implant (CI) insertion - robotic-assisted insertion and manual insertion - to better understand how they affect hearing outcomes. Participants in this study will be randomly assigned to receive their cochlear implant using one of these two techniques. Both methods are performed in a standard operating room by qualified surgeons, and both are considered safe and approved for use. The main goal is to compare how well participants hear one year after surgery based on the insertion method used. The study will also look at things like surgical time, inner ear health, and how the hearing nerve responds. All participants will receive the same type of cochlear implant device and follow-up care. This study may help guide future surgical techniques and improve outcomes for individuals receiving cochlear implants.

NCT Number	NCT07081542
Lead Sponsor	AdventHealth
Conditions	Sensorineural Hearing Loss, Bilateral Hearing Loss, Cochlear Implantation, Hearing Disorders, Hearing Disorders and Deafness, Inner Ear Disorders, Hearing Impairment
Enrollment	32 participants
Start Date	2026-01-01
Primary Completion	2027-01-31 (estimated)
Study Completion	2027-01-31 (estimated)
Updated on ClinicalTrials.gov	2026-01-02