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.
Objectives
Cochlear implants provide an effective treatment option for those with severe hearing loss, including those with preserved low frequency hearing. However, certain issues can reduce implant efficacy including intracochlear tissue response and delayed loss of residual acoustic hearing. We describe a mouse model of cochlear implantation with chronic electric stimulation that can be used to study cochlear implant biology and related pathologies.
Methods
Twelve normal hearing adult CBA/J mice underwent unilateral cochlear implantation and were evenly divided into one group receiving electric stimulation and one not. Serial impedance and neural response telemetry (NRT) measurements were made to assess implant functionality. Functionality was defined as having at least one electrode with an impedance ≤ 35 kOhms. Mouse cochleae were harvested for histology and 3D x-ray microscopy 21 days post-operatively, or, in case the implant was still functional, at a later time point when the implant failed. A separate experiment measured the hearing preservation rate in 7 adult CBA/J mice undergoing unilateral cochlear implantation with serial auditory brainstem response (ABR) and distortion product otoacoustic emissions (DPOAE).
Results
Implants maintained functionality for a mean of 35 days in the non-stimulated group and 19.8 days in the stimulated group. Reliable NRT and behavioral responses to electric stimulation were recorded. A robust intracochlear peri-implant tissue response with neo-ossification was seen in all cochleae. Six of seven mice maintained intact low frequency hearing up to 6 weeks following cochlear implantation.
Conclusions
We demonstrate the feasibility of cochlear implantation and behaviorally significant electric stimulation in the mouse, with the potential for hearing preservation. This model may be combined with established mouse models of hearing loss and the large genetic and molecular research toolkit unique to the mouse for mechanistic and therapeutic investigations of cochlear implant biology.
D-met administration in advance of noise-exposure, without further administration, significantly protects from noise-induced ABR threshold shift and OHC loss.
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.
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