Development and Evaluation of a Reusable, Force Measuring Tool for the Robot-Assisted Insertion of Cochlear Implant Electrode Arrays.

OBJECTIVE: Limitations in human kinematics during cochlear implantation induce pressure transients and increased forces on intracochlear structures. Herein, we present a novel head-mounted surgical tool designed for the motorized insertion of cochlear implant electrode arrays. The tool integrates a force measurement feature to overcome the lack of haptic feedback in current robotic solutions. METHODS: Utilizing a prototype device, we compare force measurements with those exerted on intracochlear structures in a realistic temporal bone model. Furthermore, we test the tool on six temporal bone specimens in a surgical setting to assess its performance in various anatomies. RESULTS: Force measurements exhibit good agreement with intracochlear forces, offering significantly improved resolution over manual, tactile sensing. Successful electrode array insertions in six cadaver specimens affirmed the feasibility of tool setup, motorized insertion and tool removal in different anatomies. CONCLUSION: The tool allows the robot-assisted insertion of cochlear implant electrode arrays and offers valuable insights during the surgical procedure, demonstrating promise for application in clinical contexts. SIGNIFICANCE: This instrument has the potential to aid surgeons in achieving atraumatic placement of electrodes, consequently contributing to the improvement of hearing outcomes in cochlear implantation.

Uncovering Vulnerable Phases in Cochlear Implant Electrode Array Insertion: Insights from an In Vitro Model.

OBJECTIVES: The aim of this study is to improve our understanding of the mechanics involved in the insertion of lateral wall cochlear implant electrode arrays. DESIGN: A series of 30 insertion experiments were conducted by three experienced surgeons. The experiments were carried out in a previously validated artificial temporal bone model according to established soft surgery guidelines. The use of an in vitro setup enabled us to comprehensively evaluate relevant parameters, such as insertion force, intracochlear pressure, and exact electrode array position in a controlled and repeatable environment. RESULTS: Our findings reveal that strong intracochlear pressure transients are more frequently caused during the second half of the insertion, and that regrasping the electrode array is a significant factor in this phenomenon. For choosing an optimal insertion speed, we show that it is crucial to balance slow movement to limit intracochlear stress with short duration to limit tremor-induced pressure spikes, challenging the common assumption that a slower insertion is inherently better. Furthermore, we found that intracochlear stress is affected by the order of execution of postinsertion steps, namely sealing the round window and posterior tympanotomy with autologous tissue and routing of the excess cable into the mastoid cavity. Finally, surgeons' subjective estimates of physical parameters such as speed, smoothness, and resistance did not correlate with objectively assessed measures, highlighting that a thorough understanding of intracochlear mechanics is essential for an atraumatic implantation. CONCLUSION: The results presented in this article allow us to formulate evidence-based surgical recommendations that may ultimately help to improve surgical outcome and hearing preservation in cochlear implant patients.

Cochlear implant electrode impedance subcomponents as biomarker for residual hearing.

Introduction and objectives: Maintaining the structural integrity of the cochlea and preserving residual hearing is crucial for patients, especially for those for whom electric acoustic stimulation is intended. Impedances could reflect trauma due to electrode array insertion and therefore could serve as a biomarker for residual hearing. The aim of this study is to evaluate the association between residual hearing and estimated impedance subcomponents in a known collective from an exploratory study. Methods: A total of 42 patients with lateral wall electrode arrays from the same manufacturer were included in the study. For each patient, we used data from audiological measurements to compute residual hearing, impedance telemetry recordings to estimate near and far-field impedances using an approximation model, and computed tomography scans to extract anatomical information about the cochlea. We assessed the association between residual hearing and impedance subcomponent data using linear mixed-effects models. Results: The progression of impedance subcomponents showed that far-field impedance was stable over time compared to near-field impedance. Low-frequency residual hearing demonstrated the progressive nature of hearing loss, with 48% of patients showing full or partial hearing preservation after 6 months of follow-up. Analysis revealed a statistically significant negative effect of near-field impedance on residual hearing (-3.81 dB HL per kΩ; p < 0.001). No significant effect of far-field impedance was found. Conclusion: Our findings suggest that near-field impedance offers higher specificity for residual hearing monitoring, while far-field impedance was not significantly associated with residual hearing. These results highlight the potential of impedance subcomponents as objective biomarkers for outcome monitoring in cochlear implantation.

Postoperative Impedance-Based Estimation of Cochlear Implant Electrode Insertion Depth.

OBJECTIVES: Reliable determination of cochlear implant electrode positions shows promise for clinical applications, including anatomy-based fitting of audio processors or monitoring of electrode migration during follow-up. Currently, electrode positioning is measured using radiography. The primary objective of this study is to extend and validate an impedance-based method for estimating electrode insertion depths, which could serve as a radiation-free and cost-effective alternative to radiography. The secondary objective is to evaluate the reliability of the estimation method in the postoperative follow-up over several months. DESIGN: The ground truth insertion depths were measured from postoperative computed tomography scans obtained from the records of 56 cases with an identical lateral wall electrode array. For each of these cases, impedance telemetry records were retrieved starting from the day of implantation up to a maximum observation period of 60 mo. Based on these recordings, the linear and angular electrode insertion depths were estimated using a phenomenological model. The estimates obtained were compared with the ground truth values to calculate the accuracy of the model. RESULTS: Analysis of the long-term recordings using a linear mixed-effects model showed that postoperative tissue resistances remained stable throughout the follow-up period, except for the two most basal electrodes, which increased significantly over time (electrode 11: ~10 Ω/year, electrode 12: ~30 Ω/year). Inferred phenomenological models from early and late impedance telemetry recordings were not different. The insertion depth of all electrodes was estimated with an absolute error of 0.9 mm ± 0.6 mm or 22° ± 18° angle (mean ± SD). CONCLUSIONS: Insertion depth estimations of the model were reliable over time when comparing two postoperative computed tomography scans of the same ear. Our results confirm that the impedance-based position estimation method can be applied to postoperative impedance telemetry recordings. Future work needs to address extracochlear electrode detection to increase the performance of the method.

A Sleeve-Based, Micromotion Avoiding, Retractable and Tear-Opening (SMART) Insertion Tool for Cochlear Implantation.

OBJECTIVE: In conventional cochlear implantation, the insertion of the electrode array is strongly affected by the local anatomy and human kinematics. Herein, we present a concept for an insertion tool that allows to optimize the insertion trajectory beyond anatomical constraints and stabilizes the electrode array in manual implantation. A novel sleeve-based design allows the instrument to be compliant and potentially protective to intracochlear structures, while a tear-open mechanism allows it to be removed after insertion by simply retracting the tool. METHODS: Conventional and tool-guided manual insertions were performed by expert cochlear implant surgeons in an analog temporal bone model that allows to simultaneously record intracochlear pressure, insertion forces and electrode array deformation. RESULTS: Comparison between conventional and tool-guided insertions demonstrate a substantial reduction of maximum insertion forces, force variations, transverse intracochlear electrode array movement, and pressure transients. CONCLUSION: The presented tool can be utilized in manual cochlear implantation and significantly improves key metrics associated with intracochlear trauma. SIGNIFICANCE: The instrument may ultimately help improve hearing outcomes in cochlear implantation. The versatile design may be used in both manual cochlear implantation and motorized and robotic insertion, as well as image-guided surgery.

Robotic Cochlear Implantation for Direct Cochlear Access.

Robot-assisted systems offer great potential for gentler and more precise cochlear implantation. In this article, we provide a comprehensive overview of the clinical workflow for robotic cochlear implantation using a robotic system specifically developed for a minimally invasive, direct cochlear access. The clinical workflow involves experts from various disciplines and requires training to ensure a smooth and safe procedure. The protocol briefly summarizes the history of robotic cochlear implantation. The clinical sequence is explained in detail, beginning with the assessment of patient eligibility and covering surgical preparation, preoperative planning with the special planning software, drilling of the middle ear access, intraoperative imaging to confirm the trajectory, milling of the inner ear access, insertion of the electrode array, and implant management. The steps that require special attention are discussed. As an example, the postoperative outcome of robotic cochlear implantation in a patient with advanced otosclerosis is presented. Finally, the procedure is discussed in the context of the authors' experience.

In-Vitro Study of Speed and Alignment Angle in Cochlear Implant Electrode Array Insertions.

OBJECTIVE: The insertion of the electrode array is a critical step in cochlear implantation. Herein we comprehensively investigate the impact of the alignment angle and feed-forward speed on deep insertions in artificial scala tympani models with accurate macro-anatomy and controlled frictional properties. METHODS: Motorized insertions (n=1033) were performed in six scala tympani models with varying speeds and alignment angles. We evaluated reaction forces and micrographs of the insertion process and developed a mathematical model to estimate the normal force distribution along the electrode arrays. RESULTS: Insertions parallel to the cochlear base significantly reduce insertion energies and lead to smoother array movement. Non-constant insertion speeds allow to reduce insertion forces for a fixed total insertion time compared to a constant feed rate. CONCLUSION: In cochlear implantation, smoothness and peak forces can be reduced with alignment angles parallel to the scala tympani centerline and with non-constant feed-forward speed profiles. SIGNIFICANCE: Our results may help to provide clinical guidelines and improve surgical tools for manual and automated cochlear implantation.

Fabrication of human anatomy-based scala tympani models with a hydrophilic coating for cochlear implant insertion experiments.

Electrode array insertion into the inner ear is a critical step in cochlear implantation, and artificial scala tympani models can be a valuable tool for studying the dynamics of this process. This technical note describes the fabrication of electrode array dummies and scala tympani models that address shortcomings of previously published cochlear models. In particular, we improve the reproduction of frictional properties with an easy-to-apply polymer brush coating that creates hydrophilic surfaces, and produce geometries with accurate macro-anatomy based on microtomographic scans. The presented methods rely only on commonly available materials and tools and are based on publicly available data. Our validation shows very good agreement of insertion forces both in terms of linear insertion depth and insertion speed compared to previously published measurements of insertions in cadaveric temporal bones.

Intraoperative Impedance-Based Estimation of Cochlear Implant Electrode Array Insertion Depth.

OBJECTIVE: Cochlear implant impedances are influenced by the intracochlear position of the electrodes. Herein, we present an intuitive approach to calculate tissue resistances from transimpedance recordings, ultimately enabling to estimate the insertion depth of cochlear implant electrodes. METHODS: Electrode positions were measured in computed-tomography images of 20 subjects implanted with the same lateral wall cochlear implant model. The tissue resistances were estimated from intraoperative telemetry data using bivariate spline extrapolation from the transimpedance recordings. Using a phenomenological model, the electrode insertion depths were estimated. RESULTS: The proposed method enabled the linear insertion depth of all electrodes to be estimated with an average error of 0.76 ± 0.53 mm. CONCLUSION: Intraoperative telemetry recordings correlate with the linear and angular depth of electrode insertion, enabling estimations with an accuracy that can be useful for clinical applications. SIGNIFICANCE: The proposed method can be used to objectively assess surgical outcomes during and after cochlear implantation based on non-invasive and readily available telemetry recordings.