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

NCT07081542 · AdventHealth · Updated 2 Jan 2026

What is being tested
IotaSoft Robotic Insertion System; Manual Cochlear Implant Insertion
For
Sensorineural Hearing Loss; Bilateral Hearing Loss; Cochlear Implantation; Hearing Disorders; Hearing Disorders and Deafness; Inner Ear Disorders; Hearing Impairment
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years to 80 years. About 32 people. The full rules are on the registry page.
Where
United States
When
Starts or started 1 Jan 2026, ends 31 Jan 2027. Registered 23 July 2025.
Results
None posted yet.

In the researchers' words

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.
ClinicalTrials.gov, NCT07081542

Sites

  • AdventHealth CelebrationKissimmee, Florida, United States