Drilling accuracy evaluation of a mouldable surgical targeting system for minimally invasive access to anatomic targets in the temporal bone.

PURPOSE: Minimally invasive cochlear implant surgery using a micro-stereotactic surgical targeting system with on-site moulding of the template aims for a reliable, less experience-dependent access to the inner ear under maximal reduction of trauma to anatomic structures. We present an accuracy evaluation of our system in ex-vivo testing. METHODS: Eleven drilling experiments were performed on four cadaveric temporal bone specimens. The process involved preoperative imaging after affixing the reference frame to the skull, planning of a safe trajectory preserving relevant anatomical structures, customization of the surgical template, execution of the guided drilling and postoperative imaging for determination of the drilling accuracy. Deviation between the drilled and desired trajectories was measured at different depths. RESULTS: All drilling experiments were successfully performed. Other than purposely sacrificing the chorda tympani in one experiment, no other relevant anatomy, such as facial nerve, chorda tympani, ossicles or external auditory canal were harmed. Deviation between the desired and achieved path was found to be 0.25 ± 0.16 mm at skulls' surface and 0.51 ± 0.35 mm at the target level. The closest distance of the drilled trajectories' outer circumference to the facial nerve was 0.44 mm. CONCLUSIONS: We demonstrated the usability for drilling to the middle ear on human cadaveric specimen in a pre-clinical setting. Accuracy proved to be suitable for many applications such as procedures within the field of image-guided neurosurgery. Promising approaches to reach sufficient submillimetre accuracy for CI surgery have been outlined.

Hydraulic insertions of cochlear implant electrode arrays into the human cadaver cochlea: preliminary findings.

OBJECTIVES: (1) To evaluate the feasibility of a non-invasive, novel, simple insertion tool to perform automated, slow insertions of cochlear implant electrode arrays (EA) into a human cadaver cochlea; (2) to estimate the handling time required by our tool. METHODS: Basic science study conducted in an experimental OR. Two previously anonymized human cadaver heads, three commercially available EAs, and our novel insertion tool were used for the experiments. Our tool operates as a hydraulic actuator that delivers an EA at continuous velocities slower than manually feasible. INTERVENTION(S): the human cadaver heads were prepared with a round-window approach for CI surgery in a standard fashion. Twelve EA insertion trials using our tool involved: non-invasive fixation of the tool to the head; directing the tool to the round window and EA mounting onto the tool; automated EA insertion at approximately 0.1 mm/s driven by hydraulic actuation. Outcome measurement(s): handling time of the tool; post-insertion cone-beam CT scans to provide intracochlear evaluation of the EA insertions. RESULTS: Our insertion tool successfully inserted an EA into the human cadaver cochlea (n = 12) while being attached to the human cadaver head in a non-invasive fashion. Median time to set up the tool was 8.8 (7.2-9.4) min. CONCLUSION: The first insertions into the human cochlea using our novel, simple insertion tool were successful without the need for invasive fixation. The tool requires < 10 min to set up, which is clinically acceptable. Future assessment of intracochlear trauma is needed to support its safety profile for clinical translation.

The Use of Clinically Measurable Cochlear Parameters in Cochlear Implant Surgery as Indicators for Size, Shape, and Orientation of the Scala Tympani.

OBJECTIVES: (1) To assess variations of the human intracochlear anatomy and quantify factors which might be relevant for cochlear implantation (CI) regarding surgical technique and electrode design. (2) Search for correlations of these factors with clinically assessable measurements. DESIGN: Human temporal bone study with micro computed tomography (µCT) data and analysis of intracochlear geometrical variations: µCT data of 15 fresh human temporal bones was generated, and the intracochlear lumina scala tympani (ST) and scala vestibuli were manually segmented using custom software specifically designed for accurate cochlear segmentation. The corresponding datasets were processed yielding 15 detailed, three-dimensional cochlear models which were investigated in terms of the scalae height, cross-sectional size, and rotation as well as the interrelation of these factors and correlations to others. RESULTS: The greatest anatomical variability was observed within the round window region of the cochlea (basal 45°), especially regarding the cross-sectional size of the ST and its orientation relative to the scala vestibuli, which were found to be correlated (p < 0.001). The cross-sectional height of the ST changes substantially for both increasing cochlear angles and lateral wall distances. Even small cochleae were found to contain enough space for all commercially available CI arrays. Significant correlations of individual intracochlear parameters to clinically assessable ones were found despite the small sample size. CONCLUSION: While there is generally enough space within the ST for CI, strong intracochlear anatomical variations could be observed highlighting the relevance of both soft surgical technique as well as a highly flexible and self-adapting cochlear implant electrode array design. Cochlear dimensions (especially at the round window) could potentially be used to indicate surgically challenging anatomies.

Investigation of ultra-low insertion speeds in an inelastic artificial cochlear model using custom-made cochlear implant electrodes.

PURPOSE: Latest research on cochlear implantations focuses on hearing preservation during insertion of the implant's electrode array by reducing insertion trauma. One parameter which may influence trauma is insertion speed. The objective of this study was to extend the range of examined insertion speeds to include ultra-low velocities, being lower than manually feasible, and investigate whether these reduce insertion forces. METHODS: 24 custom-made cochlear implant test samples were fabricated and inserted into an artificial scala tympani model using 12 different insertion speeds while measuring the resulting insertion forces. Three commercially available slim straight electrode carriers were inserted using the same setup to analyze whether the results are comparable. RESULTS: Insertions of the test samples using high insertion speeds (2.0/2.8 mm/s) showed significantly higher insertion forces than insertions done with low insertion speeds (0.2 mm/s) or ultra-low insertion speeds (< 0.1 mm/s). The insertions with commercial slim straight electrode arrays showed significantly reduced insertion forces when using a low insertion speed as well. CONCLUSIONS: Slow insertions showed significantly reduced insertion forces. Insertion speeds which are lower than manually feasible showed even lower insertion forces.

On the accuracy of cochlear duct length measurement in computed tomographic images.

PURPOSE: Patient specific selection of cochlear implants would benefit from pre-operative knowledge of cochlear length. Several methods for its measurement or estimation have been described in literature. This study focused on the achievable accuracy in clinically available imaging. METHODS: Five simplified cochlea models milled into porcine bone were scanned in water using clinical cone beam computed tomography. Due to their well-known dimensions these phantoms served as gold standard for the length measurements. Each phantom was measured ten times using the custom software Comet. In addition, cochleae in ten image datasets taken indiscriminately from clinical routine were measured ten times each to test the precision under realistic conditions. The results were also compared to estimations based on the diameter of the basal turn (A value) as described in literature. RESULTS: Measurement accuracy of the phantoms' lengths was high (average error: - 0.2 mm; standard deviation: 0.3 mm). The pooled standard deviation for the measurements in clinical datasets was 0.6 mm. Errors resulted mainly from problems locating the helicotrema. The estimations differed on average - 1.7 to + 0.4 mm from the manual measurements and had standard deviations between 0.5 and 0.6 mm depending on the algorithm. CONCLUSIONS: The program Comet was successfully used to accurately measure the length of the cochlea models in clinically available imaging. The lower image quality of patient scans reduced the precision of the measurement. Estimations using the A value are a quicker alternative for averagely sized cochleae in cases where the lack of accuracy is tolerable.

Insertion forces and intracochlear trauma in temporal bone specimens implanted with a straight atraumatic electrode array.

The aim of the study was to evaluate insertion forces during manual insertion of a straight atraumatic electrode in human temporal bones, and post-implantation histologic evaluation of the samples to determine whether violation of intracochlear structures is related to insertion forces. In order to minimize intracochlear trauma and preserve residual hearing during cochlear implantation, knowledge of the insertion forces is necessary. Ten fresh frozen human temporal bones were prepared with canal wall down mastoidectomy. All samples were mounted on a one-axis force sensor. Insertion of a 16-mm straight atraumatic electrode was performed from different angles to induce "traumatic" insertion. Histologic evaluation was performed in order to evaluate intracochlear trauma. In 4 of 10 samples, dislocation of the electrode into scala vestibuli was observed. The mean insertion force for all 10 procedures was 0.003 ± 0.005 N. Insertion forces measured around the site of dislocation to scala vestibuli in 3 of 4 samples were significantly higher than insertion forces at the same location of the cochleae measured in samples without trauma (p < 0.04). Mean force during the whole insertion process of the straight atraumatic electrode is lower than reported by other studies using longer electrodes. Based on our study, insertion forces leading to basilar membrane trauma may be lower than the previously reported direct rupture forces.

Determination of optimal excitation patterns for local mechanical inner ear stimulation using a physiologically-based model.

Within the field of hearing prosthetics it is known that patients with sufficient residual hearing benefit from the simultaneous employment of hearing aid and cochlear implant. Several attempts have been proposed to combine the sources of the corresponding acoustic and electric stimuli in a single, implantable device. However, since only little is known about the effect of also applying the acoustic stimulus locally from within the inner ear, the current state of research lacks detailed knowledge on the optimal stimulation at the corresponding bionic interface. Within this manuscript, a simple but yet physiologically-based inner ear model is presented which was designed specifically for the analysis of local acoustic or mechanical inner ear stimulation. A detailed model analysis is performed showing that it is capable of mirroring the known mechanical phenomena of this particular stimulation approach. Using the model, it is demonstrated how amplitude and phase shift values of stimuli applied from within the inner ear should be chosen for optimal inner ear stimulation.

Insertion trauma of a cochlear implant electrode array with Nitinol inlay.

The integration of a shape memory actuator is a potential mechanism to achieve a consistent perimodiolar position after electrode insertion during cochlear implant surgery. After warming up, and therefore activation of the shape memory effect, the electrode array will change from a straight configuration into a spiral shaped one leading to a final position close to the modiolus. The aim of this study was to investigate whether the integration of an additional thin wire (referred to as an "inlay") made of Nitinol, a well-established shape memory alloy, in a conventional hearing preservation electrode array will affect the insertion behaviour in terms of increased risk of insertion trauma. Six conventional Hybrid-L electrode arrays (Cochlear Ltd., Sydney, Australia) were modified to incorporate a wire inlay made of Nitinol. The diameter of the wires was 100 µm with a tapered tip region. Electrodes were inserted into human temporal bone specimens using a standard surgical approach. After insertion and embedding in epoxy resin, histological sections were prepared to evaluate insertion trauma. Insertion was straightforward and no difficulties were observed. The addition of a shape memory wire, thin but also strong enough to curl the electrode array, does not result in histologically detectable insertion trauma. Atraumatic insertion seems possible.

On the interdependence of insertion forces, insertion speed, and lubrication: Aspects to consider when testing cochlear implant electrodes.

OBJECTIVES: During the insertion of cochlear implant (CI) electrode arrays, forces occur which may cause trauma and poorer hearing outcomes. Unfortunately, research groups investigating factors influencing insertion forces come to contradicting results, especially regarding insertion speed. This study was conducted to investigate the origin of these contradicting results and to determine how different testing conditions influence experimental findings. METHODS: Repeated, automated insertions with three different FLEX28 CI electrode arrays (MED-EL, Innsbruck, Austria) were performed into a newly developed, anatomically correct and 3D-printed mean scala tympani phantom. The testing protocol for each electrode included variations in insertion speed (v = 0.1-2.0 mm/s) and lubrication (90%, 50%, and 10% liquid soap), resulting in 51 insertions per electrode array and a total of 153 insertions. RESULTS: The test setup and protocol allowed for repeatable insertions with only minimal change in the morphology of the insertion force profiles per testing condition. Strong but varying dependencies of the maximal insertion forces and work were found regarding both lubrication and speed: work-speed dependency is constant for the 10% lubricant, negative for the 50% lubricant and positive for the 90% lubricant. CONCLUSION: Our results can explain part of the contradicting results found within previous studies by translating interrelations known from lubricated rubber friction to the field of CI electrode array insertion. We show that the main driver behind measured bulk forces are most likely the generated friction forces, which are strongly dependent on insertion speed and lubrication. The employed test setup allows for conducting repeatable and comparable insertion studies, which can be recapitulated by other centers due to the detailed explanation of the test setup as well as the developed and freely available insertion phantom. This study hence represents another important step toward standardizing CI array insertion testing.

First clinical implementation of insertion force measurement in cochlear implantation surgery.

Purpose: The significance of atraumatic electrode array (EA) insertion in cochlear implant (CI) surgery is widely acknowledged, with consensus that forces due to EA insertion are directly correlated with insertion trauma. Unfortunately, the manual perception of these forces through haptic feedback is inherently limited, and techniques for in vivo force measurements to monitor the insertion are not yet available. Addressing this gap, we developed of a force-sensitive insertion tool capable of capturing real-time insertion forces during standard CI surgery. Methods: This paper describes the tool and its pioneering application in a clinical setting and reports initial findings from an ongoing clinical study. Data and experiences from five patients have been evaluated so far, including force profiles of four patients. Results: The initial intraoperative experiences are promising, with successful integration into the conventional workflow. Feasibility of in vivo insertion force measurement and practicability of the tool's intraoperative use could be demonstrated. The recorded in vivo insertion forces show the expected rise with increasing insertion depth. Forces at the end of insertion range from 17.2 mN to 43.6 mN, while maximal peak forces were observed in the range from 44.8 mN to 102.4 mN. Conclusion: We hypothesize that this novel method holds the potential to assist surgeons in monitoring the insertion forces and, thus, minimizing insertion trauma and ensuring better preservation of residual hearing. Future data recording with this tool can form the basis of ongoing research into the causes of insertion trauma, paving the way for new and improved prevention strategies.

A method for accurate and reproducible specimen alignment for insertion tests of cochlear implant electrode arrays.

PURPOSE: The trajectory along which the cochlear implant electrode array is inserted influences the insertion forces and the probability for intracochlear trauma. Controlling the trajectory is especially relevant for reproducible conditions in electrode insertion tests. Using ex vivo cochlear specimens, manual alignment of the invisibly embedded cochlea is imprecise and hardly reproducible. The aim of this study was to develop a method for creating a 3D printable pose setting adapter to align a specimen along a desired trajectory toward an insertion axis. METHODS: Planning points of the desired trajectory into the cochlea were set using CBCT images. A new custom-made algorithm processed these points for automated calculation of a pose setting adapter. Its shape ensures coaxial positioning of the planned trajectory to both the force sensor measuring direction and the insertion axis. The performance of the approach was evaluated by dissecting and aligning 15 porcine cochlear specimens of which four were subsequently used for automated electrode insertions. RESULTS: The pose setting adapter could easily be integrated into an insertion force test setup. Its calculation and 3D printing was possible in all 15 cases. Compared to planning data, a mean positioning accuracy of 0.21 ± 0.10 mm at the level of the round window and a mean angular accuracy of 0.43° ± 0.21° were measured. After alignment, four specimens were used for electrode insertions, demonstrating the practical applicability of our method. CONCLUSION: In this work, we present a new method, which enables automated calculation and creation of a ready-to-print pose setting adapter for alignment of cochlear specimens in insertion test setups. The approach is characterized by a high level of accuracy and reproducibility in controlling the insertion trajectory. Therefore, it enables a higher degree of standardization in force measurement when performing ex vivo insertion tests and thereby improves reliability in electrode testing.

Preclinical evaluation of a tool for insertion force measurements in cochlear implant surgery.

PURPOSE: Trauma that may be inflicted to the inner ear (cochlea) during the insertion of an electrode array (EA) in cochlear implant (CI) surgery can significantly decrease the hearing outcome of patients with residual hearing. Interaction forces between the EA and the cochlea are a promising indicator for the likelihood of intracochlear trauma. However, insertion forces have only been measured in laboratory setups. We recently developed a tool to measure the insertion force during CI surgery. Here, we present the first ex vivo evaluation of our tool with a focus on usability in the standard surgical workflow. METHODS: Two CI surgeons inserted commercially available EAs into three temporal bone specimens. The insertion force and the orientation of the tool were recorded together with camera footage. The surgeons answered a questionnaire after each insertion to evaluate the surgical workflow with respect to CI surgery. RESULTS: The EA insertion using our tool was rated successful in all 18 trials. The surgical workflow was evaluated to be equivalent to standard CI surgery. Minor handling challenges can be overcome through surgeon training. The peak insertion forces were 62.4 mN ± 26.7 mN on average. Peak forces significantly correlated to the final electrode insertion depth, supporting the assumption that the measured forces mainly correspond to intracochlear events and not extracochlear friction. Gravity-induced forces of up to 28.8 mN were removed from the signal, illustrating the importance of the compensation of such forces in manual surgery. CONCLUSION: The results show that the tool is ready for intraoperative use. In vivo insertion force data will improve the interpretability of experimental results in laboratory settings. The implementation of live insertion force feedback to surgeons could further improve residual hearing preservation.

A Tool to Enable Intraoperative Insertion Force Measurements for Cochlear Implant Surgery.

OBJECTIVE: Residual hearing preservation during cochlear implant (CI) surgery is closely linked to the magnitude of intracochlear forces acting during the insertion process. So far, these forces have only been measured in vitro. Therefore, the range of insertion forces and the magnitude of damage-inducing thresholds in the human cochlea in vivo remain unknown. We aimed to develop a method to intraoperatively measure insertion forces without negatively affecting the established surgical workflow. Initial experiments showed that this requires the compensation of orientation-dependent gravitational forces. METHODS: We devised design requirements for a force-sensing manual insertion tool. Experienced CI surgeons evaluated the proposed design for surgical safety and handling quality. Measured forces from automated and manual insertions into an artificial cochlea model were evaluated against data from a static external force sensor representing the gold standard. RESULTS: The finalized manual insertion tool uses an embedded force sensor and inertial measurement unit to measure insertion forces. The evaluation of the proposed design shows the feasibility of orientation-independent insertion force measurements. Recorded forces correspond well to externally recorded reference forces after reliable removal of gravitational disturbances. CI surgeons successfully used the tool to insert electrode arrays into human cadaver cochleae. CONCLUSION: The presented positive evaluation poses the first step towards intraoperative use of the proposed tool. Further in vitro experiments with human specimens will ensure reliable in vivo measurements. SIGNIFICANCE: Intraoperative insertion force measurements enabled by this tool will provide insights on the relationship between forces and hearing outcomes in cochlear implant surgery.

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

OBJECTIVES: Drilling a minimally invasive access to the inner ear is a demanding task in which a computer-assisted surgical system can support the surgeon. Herein, we describe the design of a new micro-stereotactic targeting system dedicated to cochlear implant (CI) surgery and its experimental evaluation in an ex vivo study. METHODS: The proposed system consists of a reusable, bone-anchored reference frame, and a patient-specific drilling jig on top of it. Individualization of the jig is simplified to a single counterbored hole drilled out of a blank. For accurate counterboring, the setup includes a manufacturing device for individual positioning of the blank. The system was tested in a preclinical setting using twelve human cadaver donors. Cone beam computed tomograph (CBCT) scans were obtained and a drilling trajectory was planned pointing towards the basal part of the cochlea. The surgical drill was moved forward manually and slowly while the jig constrained the drill along the predetermined path. RESULTS: Drilling could be performed with preservation of facial nerve in all specimens. The mean error caused by the system at the target point in front of the cochlea was 0.30 mm ± 0.11 mm including an inaccuracy of 0.09 mm ± 0.03 mm for counterboring the guiding aperture into the jig. CONCLUSION: Feasibility of the proposed system to perform a minimally invasive posterior tympanotomy approach was shown successfully in all specimens. SIGNIFICANCE: First evaluation of the new system in a comprehensive ex vivo study demonstrating sufficient accuracy and the feasibility of the whole concept.

Design of a Tool Integrating Force Sensing With Automated Insertion in Cochlear Implantation.

The quality of hearing restored to a deaf patient by a cochlear implant in hearing preservation cochlear implant surgery (and possibly also in routine cochlear implant surgery) is believed to depend on preserving delicate cochlear membranes while accurately inserting an electrode array deep into the spiral cochlea. Membrane rupture forces, and possibly, other indicators of suboptimal placement, are below the threshold detectable by human hands, motivating a force sensing insertion tool. Furthermore, recent studies have shown significant variability in manual insertion forces and velocities that may explain some instances of imperfect placement. Toward addressing this, an automated insertion tool was recently developed by Hussong et al. By following the same insertion tool concept, in this paper, we present mechanical enhancements that improve the surgeon's interface with the device and make it smaller and lighter. We also present electomechanical design of new components enabling integrated force sensing. The tool is designed to be sufficiently compact and light that it can be mounted to a microstereotactic frame for accurate image-guided preinsertion positioning. The new integrated force sensing system is capable of resolving forces as small as 0.005 N, and we provide experimental illustration of using forces to detect errors in electrode insertion.

Toward a cochlear implant electrode array with shape memory effect for post-insertion perimodiolar positioning.

For cochlear implants (CI) a final position of the electrode array (EA) along the inner wall of the spirally shaped cochlea is considered to be beneficial because it results in a closer proximity to the auditory nerve fibers. A shape memory effect (SME) could facilitate such shift of the EA toward the cochlear inner wall, but its implementation remains to be solved. The current study presents an EA prototype featuring the SME with minute adjustments of the material properties of Nitinol, a shape memory alloy, in combination with a suitable cooling strategy to prevent premature curling. Ten samples were successfully inserted by a CI surgeon into an artificial cochlear model submerged into a temperature-controllable water bath to simulate temporary hypothermia of the inner ear (31°C). Gentle insertions were possible, with an average insertion speed of 0.81 ± 0.14 mm/s. After recovery of body temperature, the desired position shift toward the modiolus was observed in all trials. Angular insertion depth increased by approximately 81.8° ± 23.4°. We demonstrate for the first time that using the body temperature responsive SME for perimodiolar EA positioning is feasible and does not impede a gentle surgical insertion.

3D Printed Cell Culture Chamber for Testing the Effect of Pump-Based Chronic Drug Delivery on Inner Ear Tissue.

Cochlear hair cell damage and spiral ganglion neuron (SGN) degeneration are the main causes of sensory neural hearing loss. Cochlear implants (CIs) can replace the function of the hair cells and stimulate the SGNs electrically. The condition of the SGNs and their spatial distance to the CI are key factors for CI-functionality. For a better performance, a high number of neurons and a closer contact to the electrode are intended. Neurotrophic factors are able to enhance SGN survival and neurite outgrowth, and thereby might optimize the electrode-nerve interaction. This would require chronic factor treatment, which is not yet established for the inner ear. Investigations on chronic drug delivery to SGNs could benefit from an appropriate in vitro model. Thus, an inner ear inspired Neurite Outgrowth Chamber (NOC), which allows the incorporation of a mini-osmotic pump for long-term drug delivery, was designed and three-dimensionally printed. The NOC's function was validated using spiral ganglion explants treated with ciliary neurotrophic factor, neurotrophin-3, or control fluid released via pumps over two weeks. The NOC proved to be suitable for explant cultivation and observation of pump-based drug delivery over the examined period, with neurotrophin-3 significantly increasing neurite outgrowth compared to the other groups.

Uncoiling the Human Cochlea-Physical Scala Tympani Models to Study Pharmacokinetics Inside the Inner Ear.

In the field of cochlear implantation, artificial/physical models of the inner ear are often employed to investigate certain phenomena like the forces occurring during implant insertions. Up to now, no such models are available for the analysis of diffusion processes inside the cochlea although drug delivery is playing an increasingly important role in this field. For easy access of the cochlea along its whole profile, e.g., for sequential sampling in an experimental setting, such a model should ideally be longitudinal/uncoiled. Within this study, a set of 15 micro-CT imaging datasets of human cochleae was used to derive an average representation of the scala tympani. The spiral profile of this model was then uncoiled along different trajectories, showing that these trajectories influence both length and volume of the resulting longitudinal model. A volumetric analysis of the average spiral model was conducted to derive volume-to-length interrelations for the different trajectories, which were then used to generate two tubular, longitudinal scala tympani models with volume and length properties matching the original, spiral profile. These models can be downloaded for free and used for reproducible and comparable simulative and experimental investigations of diffusion processes within the inner ear.

The Effect of Ultra-slow Velocities on Insertion Forces: A Study Using a Highly Flexible Straight Electrode Array.

OBJECTIVE: The present study sought to 1) characterize insertion forces resulting from a flexible straight electrode array (EA) inserted at slow and ultra-slow insertion velocities, and 2) evaluate if ultra-slow velocities decrease insertion forces independent of other variables. BACKGROUND: Low insertion forces are desirable in cochlear implant (CI) surgery to reduce trauma and preserve hearing. Recently, ultra-slow insertion velocities (lower than manually feasible) have been shown to produce significantly lower insertion forces using other EAs. METHODS: Five flexible straight EAs were used to record insertion forces into an inelastic artificial scala tympani model. Eleven trial recordings were performed for each EA at five predetermined automated, continuous insertion velocities ranging from 0.03 to 1.6 mm/s. RESULTS: An ultra-slow insertion velocity of 0.03 mm/s resulted in a median insertion force of 0.010 N at 20 mm of insertion depth, and 0.026 N at 24.3 mm-the final insertion depth. These forces represent only 24 to 29% of those measured using 1.6 mm/s. After controlling for insertion depth of the EA into the artificial scala tympani model and trial insertion number, decreasing the insertion velocity from 0.4 to 0.03 mm/s resulted in a 50% decrease in the insertion forces. CONCLUSION: Using the tested EA ultra-slow velocities can decrease insertion forces, independent of variables like insertion depth. Our results suggest ultra-slow velocities can reduce insertion forces at least 60%, compared with humanly feasible continuous velocities (≥0.9 mm/s).