Abstract
Objectives(1) To evaluate the feasibility of a non-invasive, novel, simple insertion tool to perform automated, slow insertions of cochlear implant electrode arrays (EA) into a human cadaver cochlea; (2) to estimate the handling time required by our tool.MethodsBasic science study conducted in an experimental OR. Two previously anonymized human cadaver heads, three commercially available EAs, and our novel insertion tool were used for the experiments. Our tool operates as a hydraulic actuator that delivers an EA at continuous velocities slower than manually feasible.Intervention(s): the human cadaver heads were prepared with a round-window approach for CI surgery in a standard fashion. Twelve EA insertion trials using our tool involved: non-invasive fixation of the tool to the head; directing the tool to the round window and EA mounting onto the tool; automated EA insertion at approximately 0.1 mm/s driven by hydraulic actuation.Outcome measurement(s): handling time of the tool; post-insertion cone-beam CT scans to provide intracochlear evaluation of the EA insertions.ResultsOur insertion tool successfully inserted an EA into the human cadaver cochlea (n = 12) while being attached to the human cadaver head in a non-invasive fashion. Median time to set up the tool was 8.8 (7.2–9.4) min.ConclusionThe first insertions into the human cochlea using our novel, simple insertion tool were successful without the need for invasive fixation. The tool requires < 10 min to set up, which is clinically acceptable. Future assessment of intracochlear trauma is needed to support its safety profile for clinical translation.Supplementary InformationThe online version contains supplementary material available at 10.1007/s00405-021-06979-z.
Highlights
Cochlear implants (CI) represent the standard of care for severe to profoundly hearing-impaired individuals [1] and have been suggested in the literature as the most successful neuroprosthesis to date [2, 3]
Germany variable on audiological outcomes, the previous literature suggests that decreasing the insertion velocity of electrode arrays into the cochlea can significantly lower insertion forces, [6,7,8,9] and lower insertion forces decrease the likelihood of intracochlear trauma [10, 11]
Twelve insertion trials using the Cochlea Hydro Drive” (CHD) were conducted and intracochlear insertions of the electrode arrays (EA) were achieved in all cases (Table 1)
Summary
Cochlear implants (CI) represent the standard of care for severe to profoundly hearing-impaired individuals [1] and have been suggested in the literature as the most successful neuroprosthesis to date [2, 3]. High outcome variability in CI recipients can be observed [4, 5]. Further evolution of eligibility criteria, electrode arrays, processor technologies, and surgical technique continues to take place. While it is difficult to isolate the impact from a single. The present study was a poster presentation during the American Academy of Otolaryngology-Head and Neck Surgery Foundation 2020 Virtual Annual Meeting Atraumatic CI surgery is highly desirable as it is reported to facilitate superior hearing outcomes [12, 13]
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