Clinical Evaluation of Robot-assisted Cochlear Implant Insertion in Adults Using RobOtol® Compared to Manual Insertion (ROBIICCA)
Profound Bilateral Hearing Loss
About this trial
This is an interventional treatment trial for Profound Bilateral Hearing Loss focused on measuring Profound hearing loss, cochlear implant, RobOtol®
Eligibility Criteria
Inclusion Criteria: Adult patient (age > 18) Eligible for a cochlear implant insertion according to the HAS recommendations Patient having signed an informed consent Exclusion Criteria: Exclusion Criteria: Profound hearing loss linked to meningitis Bilateral cochlear implants insertion during the same surgery Removal and re-insertion of a cochlear implant (due to a failure for example) Patient under guardianship or curatorship Contraindication to the use of the RobOtol®: Patients wearing electronic devices directly connected to the brain or nervous system. Presence of medical conditions that prohibit general anesthesia. Impossibility of viewing the anatomy adequately. Any situation that, in the doctor's opinion, might involve risk for the patient Anticipated difficulty to comply with the investigation (job transfer, geographical distance, lack of motivation, incapacity to fulfill the questionnaires), Patient previously included in Robiicca study (for the opposite site) Perimodiolar implants (not compatible with the RobOtol®)
Sites / Locations
- Lille University HospitalRecruiting
- Bordeaux University Hospital
- Brest University HospitalRecruiting
- Chu Clermont FerrandRecruiting
- Hopital BicetreRecruiting
- AP-HM
- CHRU de Montpellier
- MichelRecruiting
- CHU NICERecruiting
- AP-HP - la Pitié-Salpétrière
- C.H.R. Pontchaillou
- CHU de Saint-EtienneRecruiting
- CHRU Hautepierre
- CHRU de Tours
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Manual insertion
Robotized insertion
Manual insertion of the cochlear implant
Robotic insertion of the cochlear implant