Looking for volunteers
Impact of Robotic Cochlear Implantation on Hearing Performance in Noise
NCT06248398 · Assistance Publique - Hôpitaux de Paris · Updated 17 Feb 2025
- What is being tested
- Surgery with RobOtol®; Conventional manual surgery
- For
- Severe to Profound Hearing Loss
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years and older. About 140 people. The full rules are on the registry page.
- Where
- France
- When
- Starts or started 20 Feb 2024, ends Dec 2025. Registered 8 Feb 2024.
- Results
- None posted yet.
In the researchers' words
The purpose of this study is to compare two methods of cochlear implantation : conventional manual insertion versus robot-assisted in order to verify whether robotic insertion provides better performance in the noisy environment. To do this, we will compare the two methods of insertion of the electrode holder, on 140 patients candidates for cochlear implantation randomized in two groups (70 conventional surgery versus 70 robot-assisted surgery). All patients will be recruited during 17 months, in our Ear, nose and throat (ENT) Department of the Pitié-Salpêtrière hospital group, the first center for adult patients established in France (on average 180 patients/year). Patient will be followed for 9 months with clinical evaluation, imaging, audiometric, listening effort and quality of life assessments. These evaluations will be carried out preoperatively and postoperatively at 3 months and 6 months post-activation of the cochlear implant.
Sites
- Groupe Hospitalier Pitié-SalpêtrièreParis, France
