Clinical Implementation of Second-generation Minimally Invasive Image-guided Cochlear Implantation Surgery

Abstract

Objective: Minimally invasive, image-guided cochlear implantation (CI) surgery consists of drilling a precise tunnel from the surface of the mastoid cortex through the facial recess to target the scala tympani. In the first set of clinical trials of this technique, heat-induced facial nerve paresis (House-Brackmann II/VI) occurred on a patient on the last day of the initial trial which was scheduled to be halted secondary to a change in the regulatory requirements dictated by the 2012 the Food and Drug Administration Safety and Innovation Act requiring Investigational Device Exemption approval for previously exempted customized medical device testing. To address this adverse event, extensive changes were made to the drilling protocol; additionally, a custom insertion tool was developed. To address the Food and Drug Administration Safety and Innovation Act, an Investigational Device Exemption was submitted and, subsequently approved. Herein is described our first clinical implementation of the modified technique. Patient: Seventy-year-old with profound, postlingual sensorineural hearing loss who had previously undergone right CI via traditional approach in 2015. Intervention: Minimally invasive image-guided left CI. Main Outcome Measure: Time of intervention, final location of CI electrode array within cochlea. Results: Surgery took 155 minutes of which the largest components (in descending order) were soft tissue work, closure, and drilling. Full scala tympani insertion with angular insertion depth of 557 degrees of the electrode array was achieved. There were no complications, and the patient had an uneventful recovery and activation. Conclusions: Minimally invasive, image-guided CI surgery is achievable and reduces the mastoid depression associated with traditional CI surgery. ClinicalTrials.gov information: Study NCT03101917, Microtable Microstereotactic Frame and Drill Press and Associated Method for Cochlear Implantation Level of Evidence: Case Report.

Ex Vivo Evaluation of a Minimally Invasive Approach for Cochlear Implant Surgery

“…Our system accuracy was determined at the target point closer to the cochlea and is in the range suitable for cochlear implantation surgery as investigated in a previous study [39]. This value is also comparable to another microstereotactic frame (Microtable with 0.31 mm ± 0.10 mm) TBME-00337-2022.R1 already used in a clinical investigation [33], [34].…”

“…with several drawbacks [32]. Therefore, several groups are working on the vision of a minimally invasive approach to the inner ear and it is already shown that rigidly attached MSF [33], [34] as well as image-guided robot systems [13], [35] can provide sufficient accuracy. However, minCIS is far from being a well-established and widely used standard.…”

“…However, minCIS is far from being a well-established and widely used standard. Although the HEARO robot is sophisticated from a technological point of view, a task autonomous surgical robot may not be the optimal solution from an economic perspective [34].…”

Robot-Assisted Electrode Insertion in Cochlear Implantation Controlled by Intraoperative Electrocochleography—A Pilot Study

“…Currently, there are four systems for clinical robotic cochlear implantation available. Three of them, Microtable ® (Vanderbilt), HEARO ® (Bern) and ROSA ® (Amiens), are used for direct cochlear access but the number of cases implanted with these devices is still very limited [ 10 , 23 , 24 , 25 , 26 ]. The fourth system (RobOtol ® ) is not intended for drilling, but for robotic alignment of the electrode array and its insertion into the scala tympani.…”

Clinical Translation of an Insertion Tool for Minimally Invasive Cochlear Implant Surgery

“…With the user and design requirements met, this tool was translated to the operating room for the first time, and enabled a full ST insertion in a clinical case [48]. No backup tools were needed, although three were available.…”