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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cochlear implantation | Procedure | 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 | Other | computerized tomography (CT) scan of the facial nerve | ||
| electromyograph | Other | electromyographic verification of the facial nerve |
| Measure | Description | Time Frame |
|---|---|---|
| cochlear implantation with the ROSA robot surgery time | cochlear implantation with the ROSA robot surgery time | during surgery, day 1 |
| surgical quality based on material description and surgical technique | surgical quality based on material description and surgical technique | during surgery, day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| surgical quality based on robot precision | surgical quality based on robot precision | during surgery, day 1 |
| surgical quality based on the cochlear implantation in the cochlea | surgical quality based on the cochlear implantation in the cochlea |
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| Name | Affiliation | Role |
|---|---|---|
| Nathalie klopp-Dutote, MD | CHU amiens | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens | Amiens | 80000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34310841 | Result | Klopp-Dutote N, Lefranc M, Strunski V, Page C. Minimally invasive fully ROBOT-assisted cochlear implantation in humans: Preliminary results in five consecutive patients. Clin Otolaryngol. 2021 Nov;46(6):1326-1330. doi: 10.1111/coa.13840. Epub 2021 Aug 17. No abstract available. |
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| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D019929 | Cochlear Implantation |
| ID | Term |
|---|---|
| D013506 | Otologic Surgical Procedures |
| D013517 | Otorhinolaryngologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019919 | Prosthesis Implantation |
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| during surgery, day 1 |
| surgical quality based on intraoperative electrophysiological data | surgical quality based on intraoperative electrophysiological data | during surgery, day 1 |
| surgical quality based on pathological complications | surgical quality based on pathological complications (facial, paralysis, infection, pain) | during surgery and postoperative period (1.5 month after surgery) |
| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |