Evaluation of Insertion Forces and Cochlea Trauma Following Robotics-Assisted Cochlear Implant Electrode Array Insertion

Evaluation of Insertion Forces and Cochlea Trauma Following Robotics-Assisted Cochlear Implant Electrode Array Insertion: Hypothesis:

The objective was to evaluate the effect of cochlear implant (CI) insertion technique on electrode insertion forces and intracochlear trauma. We hypothesize that robotics-assisted insertions will reduce insertion forces and intracochlear trauma compared with manual insertions.

Background:

Variability in CI outcomes exists across patients, implant centers, surgeons, and electrode types. While surgical techniques that reduce electrode insertion trauma are well established, insertion trauma remains one contributing factor to variability in CI outcomes. Previous work demonstrates that micromechanically controlled insertion tools reduce both maximum insertion forces and insertion variability compared with manual insertions.

Methods:

CI electrode insertions were performed either by hand (n = 12) or utilizing a robotics-assisted tool (n = 12) in fresh frozen, human cadaveric cochleae using electrodes from four different CI manufacturers. Electrodes array insertion forces were additionally evaluated in benchtop cochlea models. Following cadaveric insertions, samples were imaged via high resolution x-ray microscopy to evaluate electrode position and intracochlear trauma events based on a modified Eshraghi scale.

Results:

Electrode array insertions performed by robotics-assisted system showed significantly lower insertion forces and variability. Manual electrode array insertions had a significantly higher overall trauma score of 3.1 ± 2.0 compared with 0.9 ± 1.0 for robotics-assisted insertions. Robotics-assisted insertions had higher rate of basilar membrane elevations while manual insertions showed higher rates of severe trauma events.

Conclusions:

The robotic-assisted insertion system reduced trauma events associated with CI electrode insertions in cadaveric cochleae compared with manual insertions. Surgical devices which help to precisely and more consistently insert electrodes may improve CI outcomes and hearing preservation.

Address correspondence and reprint requests to Christopher R. Kaufmann, M.D., M.S., Department of Otolaryngology–Head & Neck Surgery, University of Iowa, 200 Hawkins Dr, Iowa City, IA 52242; E-mail: Christopher-Kaufmann@uiowa.edu

Funding Sources: iotaMotion, Inc.; NIDCD T32 DC00040.

C.K. and M.H. are co-founders and directors of iotaMotion. A.H. is an iotaMotion employee. For the remaining authors none were declared.

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