Quantitative in-vitro assessment of a novel robot-assisted system for cochlear implant electrode insertion.

Purpose As an increasing number of cochlear implant candidates exhibit residual inner ear function, hearing preservation strategies during implant insertion are gaining importance. Manual implantation is known to induce traumatic force and pressure peaks. In this study, we use a validated in-vitro model to comprehensively evaluate a novel surgical tool that addresses these challenges through motorized movement of a forceps. Methods Using lateral wall electrodes, we examined two subgroups of insertions: 30 insertions were performed manually by experienced surgeons, and another 30 insertions were conducted with a robot-assisted system under the same surgeons' supervision. We utilized a realistic, validated model of the temporal bone. This model accurately reproduces intracochlear frictional conditions and allows for the synchronous recording of forces on intracochlear structures, intracochlear pressure, and the position and deformation of the electrode array within the scala tympani. Results We identified a significant reduction in force variation during robot-assisted insertions compared to the conventional procedure, with average values of 12 mN/s and 32 mN/s, respectively. Robotic assistance was also associated with a significant reduction of strong pressure peaks and a 17 dB reduction in intracochlear pressure levels. Furthermore, our study highlights that the release of the insertion tool represents a critical phase requiring surgical training. Conclusion Robotic assistance demonstrated more consistent insertion speeds compared to manual techniques. Its use can significantly reduce factors associated with intracochlear trauma, highlighting its potential for improved hearing preservation. Finally, the system does not mitigate the impact of subsequent surgical steps like electrode cable routing and cochlear access sealing, pointing to areas in need of further research.