Comparative Analysis of Robotics-Assisted and Manual Insertions of Cochlear Implant Electrode Arrays

Abstract

HypothesisRobotics-assisted cochlear implant (CI) insertions will result in reduced intracochlear trauma when compared with manual, across multiple users.BackgroundWhether intracochlear trauma and translocations are two factors that may contribute to significant variability in CI outcomes remains to be seen. To address this issue, we have developed a robotics-assisted insertion system designed to aid the surgeon in inserting electrode arrays with consistent speeds and reduced variability. This study evaluated the effect of robotics-assisted insertions on the intracochlear trauma as compared with manual insertions in cadaveric cochleae in a simulated operative environment.MethodsTwelve neurotologists performed bilateral electrode insertions into cochleae of full cadaveric heads using both the robotics-assisted system and manual hand insertion. Lateral wall electrodes from three different manufacturers (n = 24) were used and randomized between surgeons. Insertion angle of the electrode and trauma scoring were evaluated using high-resolution three-dimensional x-ray microscopy and compared between robotics-assisted and manual insertions.ResultsThree-dimensional x-ray microscopy provided excellent resolution to characterize the in situ trauma and insertion angle. Robotics-assisted insertions significantly decreased insertional intracochlear trauma as measured by reduced trauma scores compared with manual insertions (average: 1.3 versus 2.2, device versus manual, respectively; p < 0.05). There was no significant difference between insertion angles observed for manual and robotics-assisted techniques (311 ± 131° versus 307 ± 96°, device versus manual, respectively).ConclusionsRobotics-assisted insertion systems enable standardized electrode insertions across individual surgeons and experience levels. Clinical trials are necessary to investigate whether insertion techniques that reduce insertional variability and the likelihood of intracochlear trauma also improve CI auditory outcomes.

A Steadier Hand: The First Human Clinical Trial of a Single-Use Robotic-Assisted Surgical Device for Cochlear Implant Electrode Array Insertion

“…Importantly, they determined the robot-assisted procedures resulted in lower rates of translocation and were therefore less traumatic than the procedures that used manual insertion techniques. Previous cadaveric studies evaluating a similar robotic-assisted insertion device to that used in this clinical study have suggested an overall decrease in the cochlea trauma score with robotic-assisted insertions compared with manual in cadaveric insertions (30). The novelty of the current device can be highlighted by examining the differences in the robotic systems used by Daoudi et al versus the one reported in this clinical study.…”

“…A recent systematic review evaluating tip fold-over with straight electrodes found an incidence of 0.1-1.3% depending on the study (31). Additionally, other clinical studies evaluating the effects of robotic-assisted insertion on safety have found that tip fold-overs are less likely to occur with robotic-assisted insertions because of the consistent insertion speed (30,32). The results of the current study extend the current body of knowledge on this subject, although more direct comparative studies are needed.…”

Intraoperative Measurement of Insertion Speed in Cochlear Implant Surgery: A Preliminary Experience with Cochlear SmartNav

“…Suggested alternatives, such as intraoperative imaging or optical tracking, have limited implementation in current clinical practice. Slower and more atraumatic array placements are reported to have been achieved with robot-assisted insertion devices, currently under development [ 29 ].…”

Combining Intraoperative Electrocochleography with Robotics-Assisted Electrode Array Insertion

“…Robotics-assisted EA insertion is an emerging technique in hearing preservation CI that can overcome the limitations of manual insertion, with studies suggesting lower rates of translocation and cochlear trauma (7,(21)(22)(23)(24). Our group has previously described the clinical safety and utility of a single-use robotic-assisted CI EA insertion device that can delicately insert an array at constant speed as low as 0.1 mm/s (11).…”