Image-guided Cochlear Implantation Research Articles

Concept and first Implementation of an intracochlearly navigated Electrode Array for Cochlear Implantation.

Cochlear implants (CI) are an established treatment for people with deafness or severe hearing loss. To restore patients' hearing an electrode array (EA) of the CI is inserted into the cochlea to stimulate the auditory nerve. Thereby, the exact positioning and gentle insertion of the EA is crucial for optimal hearing perception outcome. Currently, only microscopic vision is available for entering the cochlea, but the critical intracochlear process during EA insertion is like a "black box" and the surgeon has to rely on haptic feedback. Methods for visualizing the insertion process during surgery are inaccurate or not suitable for routine use due to radiation exposure. To address this problem, we developed a computer-assisted and image-guided cochlear implantation system with an exact real-time visualization of the EA position during the insertion process. The system is based on an electromagnetic tracking system that measures the position and orientation of a sensor integrated into the tip of a EA prototype and visualizes it in presurgical image data. A first experiment with our system showed that a EA prototype could be inserted into a cochlea of a human temporal bone and placed with an accuracy of [Formula: see text]. A maximum insertion angle of 120° was achieved.

Validation of automatic cochlear implant electrode localization techniques using .

Cochlear implants (CIs) are standard treatment for patients who experience sensorineural hearing loss. Although these devices have been remarkably successful at restoring hearing, it is rare that they permit to achieve natural fidelity and many patients experience poor outcomes. Our group has developed image-guided CI programming techniques (IGCIP), in which image analysis techniques are used to locate the intracochlear position of CI electrodes to determine patient-customized settings for the CI processor. Clinical studies have shown that IGCIP leads to significantly improved outcomes. A crucial step is the localization of the electrodes, and rigorously quantifying the accuracy of our algorithms requires dedicated datasets. We discuss the creation of a ground truth dataset for electrode position and its use to evaluate the accuracy of our electrode localization techniques. Our final ground truth dataset includes 30 temporal bone specimens that were each implanted with one of four different types of electrode array by an experienced CI surgeon. The arrays were localized in conventional CT images using our automatic methods and manually in high-resolution images to create the ground truth. The conventional and images were registered to facilitate comparison between automatic and ground truth electrode localization results. Our technique resulted in mean errors of 0.13mm in localizing the electrodes across 30 cases. Our approach successfully permitted characterizing the accuracy of our methods, which is critical to understand their limitations for use in IGCIP.

Selecting electrode configurations for image-guided cochlear implant programming using template matching.

Cochlear implants (CIs) are neural prostheses that restore hearing using an electrode array implanted in the cochlea. After implantation, the CI processor is programmed by an audiologist. One factor that negatively impacts outcomes and can be addressed by programming is cross-electrode neural stimulation overlap (NSO). We have proposed a system to assist the audiologist in programming the CI that we call image-guided CI programming (IGCIP). IGCIP permits using CT images to detect NSO and recommend deactivation of a subset of electrodes to avoid NSO. We have shown that IGCIP significantly improves hearing outcomes. Most of the IGCIP steps are robustly automated but electrode configuration selection still sometimes requires manual intervention. With expertise, distance-versus-frequency curves, which are a way to visualize the spatial relationship learned from CT between the electrodes and the nerves they stimulate, can be used to select the electrode configuration. We propose an automated technique for electrode configuration selection. A comparison between this approach and one we have previously proposed shows that our method produces results that are as good as those obtained with our previous method while being generic and requiring fewer parameters.

Localizing landmark sets in head CTs using random forests and a heuristic search algorithm for registration initialization.

Cochlear implants (CIs) use electrode arrays that are surgically inserted into the cochlea to stimulate frequency-mapped nerve endings to treat patients with hearing loss. CIs are programmed postoperatively by audiologists using behavioral tests without information on electrode-cochlea spatial relationship. We have recently developed techniques to segment the intracochlear anatomy and to localize individual contacts in clinically acquired computed tomography (CT) images. Using this information, we have proposed a programming strategy that we call image-guided CI programming (IGCIP), and we have shown that it significantly improves outcomes for both adult and pediatric recipients. One obstacle to large-scale deployment of this technique is the need for manual intervention in some processing steps. One of these is the rough registration of images prior to the use of automated intensity-based algorithms. Although seemingly simple, the heterogeneity of our image set makes this task challenging. We propose a solution that relies on the automated random forest-based localization of multiple landmarks used to estimate an initial transformation with a point-based registration method. Results show that it produces results that are equivalent to a manual initialization. This work is an important step toward the full automation of IGCIP.

Evaluation of a high-resolution patient-specific model of the electrically stimulated cochlea.

Cochlear implants (CIs) are surgically implanted medical devices used to treat individuals with severe-to-profound sensorineural hearing loss. Although these devices have been remarkably successful at restoring audibility, many patients experience poor outcomes. Our group has developed the first image-guided CI programming technique where the electrode positions are found in CT images and used to estimate neural activation patterns, which is unique information that audiologists can use to define patient-specific processor settings. Currently, neural activation is estimated using only the distance from each electrode to the neural activation sites, which might be less accurate than using high-resolution electro-anatomical models (EAMs) to perform physics-based estimations of neural activation. We propose a patient-customized EAM approach where the EAM is spatially and electrically adapted to a patient-specific configuration. Spatial adaptation is done through nonrigid registration of the model with the patient CT image. Electrical adaptation is done by adjusting tissue resistivity parameters, so the intracochlear voltage distributions predicted by the model best match those directly measured for the patient via their implant. We found that our approach, demonstrated for [Formula: see text] patients, results in mean percent differences between direct and simulated measurements of voltage distributions of 10.9%.

Automatic selection of the active electrode set for image-guided cochlear implant programming.

Cochlear implants (CIs) are neural prostheses that restore hearing by stimulating auditory nerve pathways within the cochlea using an implanted electrode array. Research has shown when multiple electrodes stimulate the same nerve pathways, competing stimulation occurs and hearing outcomes decline. Recent clinical studies have indicated that hearing outcomes can be significantly improved by using an image-guided active electrode set selection technique we have designed, in which electrodes that cause competing stimulation are identified and deactivated. In tests done to date, an expert is needed to perform the electrode selection step with the assistance of a method to visualize the spatial relationship between electrodes and neural sites determined using image analysis techniques. We propose to automate the electrode selection step by optimizing a cost function that captures the heuristics used by the expert. Further, we propose an approach to estimate the values of parameters used in the cost function using an existing database of expert electrode selections. We test this method with different electrode array models from three manufacturers. Our automatic approach generates acceptable active electrode sets in 98.3% of the subjects tested. This approach represents a crucial step toward clinical translation of our image-guided CI programming system.

A Neuromonitoring Approach to Facial Nerve Preservation During Image-guided Robotic Cochlear Implantation.

A multielectrode probe in combination with an optimized stimulation protocol could provide sufficient sensitivity and specificity to act as an effective safety mechanism for preservation of the facial nerve in case of an unsafe drill distance during image-guided cochlear implantation. A minimally invasive cochlear implantation is enabled by image-guided and robotic-assisted drilling of an access tunnel to the middle ear cavity. The approach requires the drill to pass at distances below 1 mm from the facial nerve and thus safety mechanisms for protecting this critical structure are required. Neuromonitoring is currently used to determine facial nerve proximity in mastoidectomy but lacks sensitivity and specificity necessaries to effectively distinguish the close distance ranges experienced in the minimally invasive approach, possibly because of current shunting of uninsulated stimulating drilling tools in the drill tunnel and because of nonoptimized stimulation parameters. To this end, we propose an advanced neuromonitoring approach using varying levels of stimulation parameters together with an integrated bipolar and monopolar stimulating probe. An in vivo study (sheep model) was conducted in which measurements at specifically planned and navigated lateral distances from the facial nerve were performed to determine if specific sets of stimulation parameters in combination with the proposed neuromonitoring system could reliably detect an imminent collision with the facial nerve. For the accurate positioning of the neuromonitoring probe, a dedicated robotic system for image-guided cochlear implantation was used and drilling accuracy was corrected on postoperative microcomputed tomographic images. From 29 trajectories analyzed in five different subjects, a correlation between stimulus threshold and drill-to-facial nerve distance was found in trajectories colliding with the facial nerve (distance <0.1 mm). The shortest pulse duration that provided the highest linear correlation between stimulation intensity and drill-to-facial nerve distance was 250 μs. Only at low stimulus intensity values (≤0.3 mA) and with the bipolar configurations of the probe did the neuromonitoring system enable sufficient lateral specificity (>95%) at distances to the facial nerve below 0.5 mm. However, reduction in stimulus threshold to 0.3 mA or lower resulted in a decrease of facial nerve distance detection range below 0.1 mm (>95% sensitivity). Subsequent histopathology follow-up of three representative cases where the neuromonitoring system could reliably detect a collision with the facial nerve (distance <0.1 mm) revealed either mild or inexistent damage to the nerve fascicles. Our findings suggest that although no general correlation between facial nerve distance and stimulation threshold existed, possibly because of variances in patient-specific anatomy, correlations at very close distances to the facial nerve and high levels of specificity would enable a binary response warning system to be developed using the proposed probe at low stimulation currents.

An artifact-robust, shape library-based algorithm for automatic segmentation of inner ear anatomy in post-cochlear-implantation CT.

A cochlear implant (CI) is a device that restores hearing using an electrode array that is surgically placed in the cochlea. After implantation, the CI is programmed to attempt to optimize hearing outcome. Currently, we are testing an image-guided CI programming (IGCIP) technique we recently developed that relies on knowledge of relative position of intracochlear anatomy to implanted electrodes. IGCIP is enabled by a number of algorithms we developed that permit determining the positions of electrodes relative to intra-cochlear anatomy using a pre- and a post-implantation CT. One issue with this technique is that it cannot be used for many subjects for whom a pre-implantation CT was not acquired. Pre-implantation CT has been necessary because it is difficult to localize the intra-cochlear structures in post-implantation CTs alone due to the image artifacts that obscure the cochlea. In this work, we present an algorithm for automatically segmenting intra-cochlear anatomy in post-implantation CTs. Our approach is to first identify the labyrinth and then use its position as a landmark to localize the intra-cochlea anatomy. Specifically, we identify the labyrinth by first approximately estimating its position by mapping a labyrinth surface of another subject that is selected from a library of such surfaces and then refining this estimate by a standard shape model-based segmentation method. We tested our approach on 10 ears and achieved overall mean and maximum errors of 0.209 and 0.98 mm, respectively. This result suggests that our approach is accurate enough for developing IGCIP strategies based solely on post-implantation CTs.

Forces and Trauma Associated with Minimally Invasive Image‐Guided Cochlear Implantation

Minimally invasive image-guided cochlear implantation (CI) utilizes a patient-customized microstereotactic frame to access the cochlea via a single drill-pass. We investigate the average force and trauma associated with the insertion of lateral wall CI electrodes using this technique. Assessment using cadaveric temporal bones. Laboratory setup. Microstereotactic frames for 6 fresh cadaveric temporal bones were built using CT scans to determine an optimal drill path following which drilling was performed. CI electrodes were inserted using surgical forceps to manually advance the CI electrode array, via the drilled tunnel, into the cochlea. Forces were recorded using a 6-axis load sensor placed under the temporal bone during the insertion of lateral wall electrode arrays (2 each of Nucleus CI422, MED-EL standard, and modified MED-EL electrodes with stiffeners). Tissue histology was performed by microdissection of the otic capsule and apical photo documentation of electrode position and intracochlear tissue. After drilling, CT scanning demonstrated successful access to cochlea in all 6 bones. Average insertion forces ranged from 0.009 to 0.078 N. Peak forces were in the range of 0.056 to 0.469 N. Tissue histology showed complete scala tympani insertion in 5 specimens and scala vestibuli insertion in the remaining specimen with depth of insertion ranging from 360° to 600°. No intracochlear trauma was identified. The use of lateral wall electrodes with the minimally invasive image-guided CI approach was associated with insertion forces comparable to traditional CI surgery. Deep insertions were obtained without identifiable trauma.

Minimally Invasive Image‐Guided Cochlear Implantation for Pediatric Patients: Clinical Feasibility Study

Minimally invasive image-guided cochlear implantation (CI) involves accessing the cochlea via a linear path from the lateral skull to the cochlea avoiding vital structures including the facial nerve. Herein, we describe and demonstrate the feasibility of the technique for pediatric patients. Prospective. Children's Hospital. Thirteen pediatric patients (1.5 to 8 years) undergoing traditional CI participated in this Institutional Review Board-approved study. Three fiducial markers were bone-implanted surrounding the ear, and a CT scan was acquired. The CT scan was processed to identify the marker locations and critical structures of the temporal bone. A safe linear path was determined to target the cochlea avoiding damage to vital structures. A custom microstereotactic frame was fabricated that would mount on the fiducial markers and constrain a tool to the desired trajectory. After traditional mastoidectomy and prior to cochleostomy, the custom microstereotactic frame was mounted on the bone-implanted markers to confirm that the achieved trajectory was safe and accurately accessed the cochlea. For all the 13 patients, it was possible to determine a safe trajectory to the cochlea. Custom microstereotactic frames were validated successfully on 9 patients. Two of these patients had inner ear malformations, and this technique helped the surgeon confirm ideal location for cochleostomy. For patients with normal anatomy, the mean and standard deviation of the closest distance of the trajectory to facial nerve and chorda tympani were 1.1 ± 0.3 mm and 1.2 ± 0.5 mm, respectively. Minimally invasive image-guided CI is feasible for pediatric patients.

Minimally invasive image‐guided cochlear implantation surgery: First report of clinical implementation

Minimally invasive image-guided approach to cochlear implantation (CI) involves drilling a narrow, linear tunnel to the cochlea. Reported herein is the first clinical implementation of this approach. Prospective cohort study. On preoperative computed tomography (CT), a safe linear trajectory through the facial recess targeting the scala tympani was planned. Intraoperatively, fiducial markers were bone-implanted, a second CT was acquired, and the trajectory was transferred from preoperative to intraoperative CT. A customized microstereotactic frame was rapidly designed and constructed to constrain a surgical drill along the desired trajectory. Following sterilization, the frame was employed to drill the tunnel to the middle ear. After lifting a tympanomeatal flap and performing a cochleostomy, the electrode array was threaded through the drilled tunnel and into the cochlea. Eight of nine patients were successfully implanted using the proposed approach with six insertions completely within the scala tympani. Traditional mastoidectomy was performed on one patient following difficulty threading the electrode array via the narrow tunnel. Other difficulties encountered included use of the backup implant when an electrode was dislodged during threading via the tunnel, tip fold-over, and facial nerve paresis (House-Brackmann II/VI at 12 months) secondary to heat during drilling. The average time of intervention was 182 ± 36 minutes. Minimally invasive image-guided CI is clinically achievable. Further clinical study is necessary to address technological difficulties during drilling and insertion, and to assess potential benefits including decreased time of intervention, standardization of surgical intervention, and decreased tissue dissection potentially leading to shorter recovery and earlier implant activation.

Minimally Invasive, Image‐Guided Cochlear Implantation for Pediatric Patients: A Clinical Feasibility Study

Objectives: Minimally-invasive, image-guided cochlear implantation (CI) involves accessing the cochlea via a linear path from the lateral skull to the cochlea avoiding vital structures, including the facial nerve. Herein, we describe and demonstrate the feasibility of the technique for pediatric patients. Methods: Thirteen pediatric patients (1.5 to 8 years) undergoing traditional CI in a children’s hospital participated in this institutional review board-approved study. Three fiducial markers were bone-implanted surrounding the ear, and a computed tomography (CT) scan was acquired. The CT scan was processed to identify the marker locations and critical structures of the temporal bone. A safe linear path was then determined to target the cochlea, avoiding damage to vital structures. A custom microstereotactic frame was then fabricated that would mount on the fiducial markers and constrain a tool to the desired trajectory. After traditional mastoidectomy and prior to cochleostomy, the custom microstereotactic frame was mounted on the bone-implanted markers to confirm that the achieved trajectory is safe and accurately accesses the cochlea. Results: For all the 13 patients, it was possible to determine a safe trajectory to the cochlea. Custom microstereotactic frames were fabricated for the desired trajectory and validated successfully on nine patients. Two of these patients had inner ear malformation, and this technique helped the surgeon identify the location for cochleostomy. For patients with normal anatomy, the closest distance of the trajectory to facial nerve and chorda tympani were 1.26 ± 0.32 mm and 0.97 ± 0.40 mm, respectively. Conclusions: Minimally-invasive, image-guided cochlear implantation is feasible for pediatric patients.

Forces and Trauma Associated with Minimally‐Invasive, Image‐Guided Cochlear Implantation

Objectives: Minimally-invasive, image-guided cochlear implantation (CI) uses a patient-customized microstereotactic frame to access the cochlea via a single drill-pass. We investigated the average force and trauma associated with the insertion of lateral wall CI electrodes using this technique. Methods: Microstereotactic frames for 6 fresh cadaveric temporal bones were built using computed tomography (CT) scans to determine an optimal drill path, following which drilling was performed. A tympanomeatal flap was raised, the round window (RW) overhang was taken down, and the RW membrane was reflected posteriorly. CI electrodes were inserted using surgical forceps to manually advance the CI electrode array, via the drilled tunnel, into the cochlea. Forces were recorded using a 6-axis load sensor placed under the temporal bone during insertion of lateral wall electrode arrays (2 each of Nucleus CI422, MED-EL standard, and MED-EL standard with stiffeners). Tissue histology was performed by removing the lateral wall of the cochlea allowing photo-documentation of electrode position and microscopic assessment of intracochlear tissue. Results: After drilling, CT scanning demonstrated successful access to cochleae in all 6 bones. Average insertion forces were 0.0088-0.0780N. Peak forces were 0.0564-0.4688N. Single factor analysis of variance was not statistically significant comparing average forces of different electrodes ( P = 0.77). Tissue histology showed complete scala tympani insertion in all specimens with depth of insertion ranging from 360-600°. No intracochlear trauma was identified. Conclusions: In this cadaver model with a minimally-invasive, image-guided CI approach, the use of lateral wall electrodes was associated with insertion forces comparable to traditional CI surgery. Deep insertions were obtained without identifiable trauma.

Validation of minimally invasive, image-guided cochlear implantation using Advanced Bionics, Cochlear, and Medel electrodes in a cadaver model

Validation of a novel minimally invasive, image-guided approach to implant electrodes from three FDA-approved manufacturers-Medel, Cochlear, and Advanced Bionics-in the cochlea via a linear tunnel from the lateral cranium through the facial recess to the cochlea. Custom microstereotactic frames that mount on bone-implanted fiducial markers and constrain the drill along the desired path were utilized on seven cadaver specimens. A linear tunnel was drilled from the lateral skull to the cochlea followed by a marginal, round window cochleostomy and insertion of the electrode array into the cochlea through the drilled tunnel. Post-insertion CT scan and histological analysis were used to analyze the results. All specimens ([Formula: see text]) were successfully implanted without visible injury to the facial nerve. The Medel electrodes ([Formula: see text]) had minimal intracochlear trauma with 8, 8, and 10 (out of 12) electrodes intracochlear. The Cochlear lateral wall electrodes (straight research arrays) ([Formula: see text]) had minimal trauma with 20 and 21 of 22 electrodes intracochlear. The Advanced Bionics electrodes ([Formula: see text]) were inserted using their insertion tool; one had minimal insertion trauma and 14 of 16 electrodes intracochlear, while the other had violation of the basilar membrane just deep to the cochleostomy following which it remained in scala vestibuli with 13 of 16 electrodes intracochlear. Minimally invasive, image-guided cochlear implantation is possible using electrodes from the three FDA-approved manufacturers. Lateral wall electrodes were associated with less intracochlear trauma suggesting that they may be better suited for this surgical technique.

Automatic Pre- to Intra-Operative CT Registration for Image-Guided Cochlear Implant Surgery

Percutaneous cochlear implantation (PCI) is a minimally-invasive image-guided cochlear implant approach, where access to the cochlea is achieved by drilling a linear channel from the skull surface to the cochlea. The PCI approach requires pre- and intra-operative planning. Computation of a safe linear drilling trajectory is performed in a preoperative CT. This trajectory is mapped to intraoperative space using the transformation matrix that registers the pre- and intra-operative CTs. However, the difference in orientation between the pre- and intra-operative CTs is too extreme to be recovered by standard, gradient descent-based registration methods. Thus far, the registration has been initialized manually by an expert. In this paper, we present a method that aligns the scans completely automatically. We compared the performance of the automatic approach to the registration approach when an expert does the manual initialization on 11 pairs of scans. There is a maximum difference of 0.18 mm between the entry and target points of the trajectory mapped with expert initialization and the automatic registration method. This suggests that the automatic registration method is accurate enough to be used in a PCI surgery.