Cochlear Hearing Loss, Implant
Conditions
Keywords
cochlear implant, robotic, mini-invasive
Brief summary
Cochlear Implantation is a system developed to restore hearing in people with profound sensorineural hearing loss, whose classical hearing aids are ineffective. Surgery is necessary to insert the internal part into the cochlea and requires milling the mastoid to access the round window. This approach is technically difficult, and is performed under a microscope by an experienced surgeon. The development of a surgical technique that is both safer and less invasive is currently possible thanks to robotics.
Detailed description
The ROSA robot coupled to the O-Arm scanner will guide the milling to the round window, whose path has been previously modeled, with the identification of the facial nerve. Milling will be done in 2 stages with a CT (computerised tomography scan) and electromyographic verification of the facial nerve. The insertion of the implant will be performed manually under endoscopic control. The preoperative and postoperative course of the patient will be identical.
Interventions
PROCEDUREcochlear implantation
cochlear implantation is a system developed to restore hearing in people with profound sensorineural hearing loss, whose classical hearing aids are ineffective. Surgery is necessary to insert the internal part into the cochlea and requires milling the mastoid to access the round window. This approach is technically difficult, and is performed under a microscope by an experienced surgeon.
computerized tomography (CT) scan of the facial nerve
OTHERelectromyograph
electromyographic verification of the facial nerve
Sponsors
Centre Hospitalier Universitaire, Amiens
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients eligible for cochlear implantation in CHU Amiens * patient more than 18 years old.
Exclusion criteria
* malformation or significant antecedent of mastoidectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cochlear implantation with the ROSA robot surgery time | during surgery, day 1 | cochlear implantation with the ROSA robot surgery time |
| surgical quality based on material description and surgical technique | during surgery, day 1 | surgical quality based on material description and surgical technique |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| surgical quality based on robot precision | during surgery, day 1 | surgical quality based on robot precision |
| surgical quality based on the cochlear implantation in the cochlea | during surgery, day 1 | surgical quality based on the cochlear implantation in the cochlea |
| surgical quality based on intraoperative electrophysiological data | during surgery, day 1 | surgical quality based on intraoperative electrophysiological data |
| surgical quality based on pathological complications | during surgery and postoperative period (1.5 month after surgery) | surgical quality based on pathological complications (facial, paralysis, infection, pain) |
Countries
France
Outcome results
None listed