Crossing borders in Cochlear Implantation – from research to clinical application of minimally invasive drilling

Introduction: The surgical procedure of cochlear implantation remained mainly unchanged for decades. Today, robotics in otologic surgery aim for two main goals as we have summarized in [1]:1) Access to a target structure in a minimally invasive manner with high accuracy2) Assisting the insertion of electrodes.

Methods: We addressed (1) in an ongoing study (MHH IRB 9030_BO_S_2020) with 11 adult patients undergoing cochlear implantation. The first six patients involved sham drill bits, as reported in [2]. In this work, we present the results (usability, accuracy and surgical workflow analysis) of the remaining five patients, involving actual drilling the access tunnel with the help of a mini-stereotactic frame and patient specific positioning jigs.

Results: The facial nerve and other risk structures were preserved as planned and the trajectory was deemed suitable for electrode insertion. No post-operative study-related adverse events were reported. In two cases the surgery was reverted to the conventional approach due to technical issues with the steam sterilizer.DiscussionJig-guided access to the middle is both, feasible and safe. It is possible to integrate in the operating workflow requiring neither setting up a robotic arm, nor a navigation system. This benefit, combined with a single bone-screw fixation concept contributed to the success, showing that the required accuracy was reached in challenging clinical conditions and showcase a successful transfer of basic research into a product realization.

References [1]: Lenarz et al. (2023). Robotics in Neurotology. In Robotics in Skull-Base Surgery (pp. 73-92). Springer Nature.[2]: Salcher et al. (2022). Minimally invasive cochlear implantation: first-in-man of patient-specific positioning jigs. Frontiers in Neurology

Conflict-of-Interest: The authors SJ, MK and TL declare being limited partners of HörSys IP GmbH & Co. KG, which holds a financial stake in OtoJig GmbH, a German company that owns and further develops the described technology. SJ, FR, MK, and JS are employed by OtoJig GmbH. MF is employed by MED-EL Deutschland GmbH.