Abstract
To demonstrate the feasibility of robotic middle ear access in a clinical setting, nine adult patients with severe-to-profound hearing loss indicated for cochlear implantation were included in this clinical trial. A keyhole access tunnel to the tympanic cavity and targeting the round window was planned based on preoperatively acquired computed tomography image data and robotically drilled to the level of the facial recess. Intraoperative imaging was performed to confirm sufficient distance of the drilling trajectory to relevant anatomy. Robotic drilling continued toward the round window. The cochlear access was manually created by the surgeon. Electrode arrays were inserted through the keyhole tunnel under microscopic supervision via a tympanomeatal flap. All patients were successfully implanted with a cochlear implant. In 9 of 9 patients the robotic drilling was planned and performed to the level of the facial recess. In 3 patients, the procedure was reverted to a conventional approach for safety reasons. No change in facial nerve function compared to baseline measurements was observed. Robotic keyhole access for cochlear implantation is feasible. Further improvements to workflow complexity, duration of surgery, and usability including safety assessments are required to enable wider adoption of the procedure.
Highlights
Advances in image guidance, robotic technology and minimally-invasive techniques offer an opportunity to transform inner ear surgery from open procedures to keyhole approaches
Of 43 initially assessed subjects planned for cochlear implantation, 29 patients were screened for facial recess size, the other 14 patients were excluded because one or more of the other inclusion criteria were unmet
All nine patients were implanted with a cochlear implant (CI) (SYNCHRONY, MED-EL, Innsbruck, Austria) under full preservation of facial nerve function
Summary
Robotic technology and minimally-invasive techniques offer an opportunity to transform inner ear surgery from open procedures to keyhole approaches. Over four decades after the description by House [1], conventional cochlear implant (CI) surgery remains essentially unchanged. Alternative implantation techniques to further improve patient outcomes such as reduced. Support by commercial partners was provided in the form of research material and in-kind contributions. None of the commercial funders had any role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript
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