Curvature analysis of CI electrode arrays: a novel approach to categorize perimodiolar positions without anatomical landmarks.

PURPOSE: Perimodiolar electrode arrays may be positioned regular, over-inserted or under-inserted into the cochlea depending on the cochlear size and shape. The study aimed to examine whether there are differences between these groups in the local curvature along the intracochlear array. Individual curvature variables were developed to categorize the groups and the relationship between the curvature and the angular insertion depth at the electrode tip was analyzed. METHODS: The curvature along the intracochlear array was measured in the CBCT image of 85 perimodiolar electrodes of a single type. The mean curvature and the ratio of the mean curvature at contacts E14-16 to the mean curvature at E7-8 (bowing ratio) were calculated across the array, and its true positive rate (TPR) and false positive rate (FPR) were calculated to establish optimal threshold values to categorize the groups. RESULTS: 68.2% of the cases were categorized as regular positioned, 22.4% had an over-insertion and 9.4% had an under-insertion. The mean curvature was significantly weaker with under-insertion (< 342°) than with normal insertion depth (≥ 342°). With an over-insertion, the bowing ratio was < 1 and otherwise > 1. Both the mean curvature and bowing ratio were found to have an optimal threshold value with high TPR (= 1.00) and low FPR (≤ 0.06) for categorizing under-insertion and over-insertion, respectively. CONCLUSION: Curvature analysis is a useful tool to assess if a perimodiolar electrode array has been inserted deep enough into the cochlea. Independent of critical anatomical landmarks, over-inserted arrays and under-inserted arrays could be well categorized by using individual curvature variables. The results need to be validated using additional data sets.

Evaluation of CI electrode position from imaging: comparison of an automated technique with the established manual method.

BACKGROUND: A manual evaluation of the CI electrode position from CT and DVT scans may be affected by diagnostic errors due to cognitive biases. The aim of this study was to compare the CI electrode localization using an automated method (image-guided cochlear implant programming, IGCIP) with the clinically established manual method. METHODS: This prospective experimental study was conducted on a dataset comprising N=50 subjects undergoing cochlear implantation with a Nucleus® CI532 or CI632 Slim Modiolar electrode. Scalar localization, electrode-to-modiolar axis distances (EMD) and angular insertion depth (aDOI) were compared between the automated IGCIP tool and the manual method. Two raters made the manual measurements, and the interrater reliability (±1.96·SD) was determined as the reference for the method comparison. The method comparison was performed using a correlation analysis and a Bland-Altman analysis. RESULTS: Concerning the scalar localization, all electrodes were localized both manually and automatically in the scala tympani. The interrater differences ranged between ±0.2 mm (EMD) and ±10° (aDOI). There was a bias between the automatic and manual method in measuring both localization parameters, which on the one hand was smaller than the interrater variations. On the other hand, this bias depended on the magnitude of the EMD respectively aDOI. A post-hoc analysis revealed that the deviations between the methods were likely due to a different selection of mid-modiolar axis. CONCLUSIONS: The IGCIP is a promising tool for automated processing of CT and DVT scans and has useful functionality such as being able to segment the cochlear using post-operative scans. When measuring EMD, the IGCIP tool is superior to the manual method because the smallest possible distance to the axis is determined depending on the cochlear turn, whereas the manual method selects the helicotrema as the reference point rigidly. Functionality to deal with motion artifacts and measurements of aDOI according to the consensus approach are necessary, otherwise the IGCIP is not unrestrictedly ready for clinical use.

Evaluation of a Transimpedance Matrix Algorithm to Detect Anomalous Cochlear Implant Electrode Position.

INTRODUCTION: Transimpedance measurements from cochlear implant electrodes have the potential to identify anomalous electrode array placement, such as tip fold-over (TFO) or fold-back, basal electrode kinking, or buckling. Analysing transimpedance may thus replace intraoperative or post-operative radiological imaging to detect any potential misplacements. A transimpedance algorithm was previously developed to detect deviations from a normal electrode position with the aim of intraoperatively detecting TFO. The algorithm had been calibrated on 35 forced, tip folded electrode arrays in six temporal bones to determine the threshold criterion required to achieve a sensitivity of 100%. Our primary objective here was to estimate the specificity of this TFO algorithm in patients, in a prospective study, for a series of electrode arrays shown to be normally inserted by post-operative imaging. METHODS: Intracochlear voltages were intraoperatively recorded for 157 ears, using Cochlear's Custom Sound™ EP 5 electrophysiological software (Cochlear Ltd., Sydney, NSW, Australia), for both Nucleus® CI512 and CI532 electrode arrays. The algorithm analysed the recorded 22 × 22 transimpedance matrix (TIM) and results were displayed as a heatmap intraoperatively, only visible to the technician in the operating theatre. After all clinical data were collected, the algorithm was evaluated on the bench. The algorithm measures the transimpedance gradients and corresponding phase angles (θ) throughout the TIM and calculates the gradient phase range. If this was greater than the predetermined threshold, the algorithm classified the electrode array insertion as having a TFO. RESULTS: Five ears had no intraoperative TIM and four anomalous matrices were identified from heatmaps and removed from the specificity analysis. Using the 148 remaining data sets (n = 103 CI532 and n = 45 CI512), the algorithm had an average specificity of 98.6% (95.80%-99.75%). CONCLUSION: The algorithm was found to be an effective screening tool for the identification of TFOs. Its specificity was within acceptable levels and resulted in a positive predictive value of 76%, with an estimated incidence of fold-over of 4% in perimodiolar arrays. This would mean 3 out of 4 cases flagged as a fold-over would be correctly identified by the algorithm, with the other being a false positive. The measurements were applied easily in theatre allowing it to be used as a routine clinical tool for confirming correct electrode placement.

Quality-assured training in the evaluation of cochlear implant electrode position: a prospective experimental study.

BACKGROUND: The objective of this study was to demonstrate the utility of an approach in training predoctoral medical students, to enable them to measure electrode-to-modiolus distances (EMDs) and insertion-depth angles (aDOIs) in cochlear implant (CI) imaging at the performance level of a single senior rater. METHODS: This prospective experimental study was conducted on a clinical training dataset comprising patients undergoing cochlear implantation with a Nucleus® CI532 Slim Modiolar electrode (N = 20) or a CI512 Contour Advance electrode (N = 10). To assess the learning curves of a single medical student in measuring EMD and aDOI, interrater differences (senior-student) were compared with the intrarater differences of a single senior rater (test-retest). The interrater and intrarater range were both calculated as the distance between the 0.1th and 99.9th percentiles. A "deliberate practice" training approach was used to teach knowledge and skills, while correctives were applied to minimize faulty data-gathering and data synthesis. RESULTS: Intrarater differences of the senior rater ranged from - 0.5 to 0.5 mm for EMD and - 14° to 16° for aDOI (respective medians: 0 mm and 0°). Use of the training approach led to interrater differences that matched this after the 4th (EMD) and 3rd (aDOI) feedback/measurement series had been provided to the student. CONCLUSIONS: The training approach enabled the student to evaluate the CI electrode position at the performance level of a senior rater. This finding may offer a basis for ongoing clinical quality assurance for the assessment of CI electrode position.

Clinical investigation of the Nucleus Slim Modiolar Electrode.

AIMS: The Nucleus CI532 cochlear implant incorporates a new precurved electrode array, i.e., the Slim Modiolar electrode (SME), which is designed to bring electrode contacts close to the medial wall of the cochlea while avoiding trauma due to scalar dislocation or contact with the lateral wall during insertion. The primary aim of this prospective study was to determine the final position of the electrode array in clinical cases as evaluated using flat-panel volume computed tomography. METHODS: Forty-five adult candidates for unilateral cochlear implantation were recruited from 8 centers. Eleven surgeons attended a temporal bone workshop and received further training with a transparent plastic cochlear model just prior to the first surgery. Feedback on the surgical approach and use of the SME was collected via a questionnaire for each case. Computed tomography of the temporal bone was performed postoperatively using flat-panel digital volume tomography or cone beam systems. The primary measure was the final scalar position of the SME (completely in scala tympani or not). Secondly, medial-lateral position and insertion depth were evaluated. RESULTS: Forty-four subjects received a CI532. The SME was located completely in scala tympani for all subjects. Pure round window (44% of the cases), extended round window (22%), and inferior and/or anterior cochleostomy (34%) approaches were successful across surgeons and cases. The SME was generally positioned close to the modiolus. Overinsertion of the array past the first marker tended to push the basal contacts towards the lateral wall and served only to increase the insertion depth of the first electrode contact without increasing the insertion depth of the most apical electrode. Complications were limited to tip fold-overs encountered in 2 subjects; both were attributed to surgical error, with both reimplanted successfully. CONCLUSIONS: The new Nucleus CI532 cochlear implant with SME achieved the design goal of producing little or no trauma as indicated by consistent scala tympani placement. Surgeons should be carefully trained to use the new deployment method such that tip fold-overs and over insertion may be avoided.

Effects of Intraoperative Cochlear Implant Electrode Conditioning on Impedances and Electrically Evoked Compound Action Potentials.

OBJECTIVE: The current study investigates whether, during a Cochlear Implant (CI) surgery, conditioning (i.e. applying short bursts of electrical stimulation) within a saline solution can have positive effects on subsequent intra-operative measurements. We hypothesize that, based on previous research, the impedance values will be reduced, and that the reproducibility of Electrically Evoked Compound Action Potentials (ECAPs) is improved as a result of conditioning. METHODS: We conditioned half of the electrode contacts, within a saline solution, before CI insertion, using 23 MED-EL implants. Impedance was measured for both the conditioned and non-conditioned groups at five time points. Repeated ECAP recordings were measured and compared between the conditioned and non-conditioned groups. RESULTS: Impedance of the electrode contacts were reduced by 31% after conditioning in saline solution; however, there were no clinically relevant differences after the implantation of the electrode array. The hypothesis that measurement reproducibility would be increased after conditioning could not be confirmed with our data. Within the saline solution, we observed that 44% of the electrode contacts were covered with air bubbles, which most disappeared after implantation. However, these air bubbles limited the effectiveness of the conditioning within the saline solution. Lastly, the effect of conditioning on the reference electrode stimulation was approximately 16% of the total reduction in impedance. CONCLUSION: Our data does not suggest that intraoperative conditioning is clinically required for cochlear implantation with MED-EL implants. Additionally, an in-vivo ECAP recording can be considered as a method of conditioning the electrode contacts. SIGNIFICANCE: We confirm that the common clinical practice does not need to be changed.

Optimizing the efficiency of ECAP measurements due to interpolation.

BACKGROUND: Thresholds of electrically evoked compound action potentials (TECAP) may serve as starting points for electrophysiologically based fitting of cochlear implants. Absent TECAP data at single electrodes reduces the number of data points available for fitting and can be substituted by interpolation of measured data points. AIM: To compare complete TECAP profiles with interpolated TECAP profiles of 5/22 (∼22.7%) and 11/22 (50%) electrode contacts. MATERIAL AND METHODS: Single-centre, retrospective, observational study of data from 624 ears implanted with a Slim Modiolar (CI ×32) or Contour Advance (CI ×12, CI24RE(CA)) electrode array (Cochlear Ltd). The deviation of the complete measured TECAP profile from the same profile with missing and therefore interpolated TECAP values was quantified. RESULTS: Interpolated TECAP profiles significantly differ from complete measured profiles especially at the basal and apical electrodes. Reference data for Slim Modiolar and Contour Advance electrodes mean profiles are provided. CONCLUSIONS AND SIGNIFICANCE: Reducing the number of measured TECAP electrodes has to be weighted against losses in the TECAP accuracy of interpolated values. A clinically acceptable compromise may be a reduction from 22 to 11 even non-equidistant data points. While reducing ECAP measurement time, it is accompanied by a minimal loss of accuracy of the TECAP threshold profile.

Electrode Translocations in Perimodiolar Cochlear Implant Electrodes: Audiological and Electrophysiological Outcome.

INTRODUCTION: Despite using the soft-surgery technique, cochlear implantation may increase the damage of the intracochlear structures due to a scalar translocation of the electrode. The aim of this work was to investigate the incidence as well as the audiological and electrophysiological outcome for electrode translocations and complete scala tympani insertions of perimodiolar electrodes within a large group of patients. MATERIAL AND METHODS: The investigations were performed retrospectively on 255 adult subjects with a Nucleus Contour Advance or Slim Modiolar electrode (Cochlear Ltd.). The scalar position was assessed by postoperative rotational tomography. Intraoperative and one year after CI activation measured ECAP thresholds were examined as well as the postoperative speech recognition in quiet using the Freiburg monosyllable word test. RESULTS: The incidence of a translocation was significantly lower with the Slim Modiolar than with the Contour Advance electrode (5.1% versus 32.3%; p<0.05). With a scala tympani placement the median speech recognition score was 75% (range: 20- 100%) with the Contour Advance and 72.5% (range: 27.5-95%) with the Slim Modiolar electrode. In cases with an electrode translocation, speech recognition scores show a median of 75% (range: 45-100%) and 73.8% (range: 40-80%), respectively. No significant differences in speech recognition were found between translocations and scala tympani insertions with both electrodes. Compared to scala tympani insertions, electrode translocations yielded higher ECAP thresholds at apical and medial electrode contacts (p<0.05). CONCLUSION: The incidence of an electrode translocation is determined for both perimodiolar electrode types analyzed in this work. ECAP measurements provide additional information for detecting translocations compared to radiological imaging. However, the postoperative speech recognition in quiet was not affected by the scalar position in the electrodes examined here.

Comparison of Perimodiolar Electrodes: Imaging and Electrophysiological Outcomes.

BACKGROUND: The perimodiolar CI532 Slim Modiolar electrode has been designed to bring the electrode contacts close to auditory nerve while reducing cochlear trauma during its insertion. It is currently unknown to what extent the electrode position and electrophysiological outcomes of the Slim Modiolar electrode differ from other perimodiolar electrodes. OBJECTIVES: The objective was to compare the electrode position and electrophysiological outcomes between the CI532 Slim Modiolar and CI512 Contour Advance electrode. METHOD: Forty-six adult patients received a Slim Modiolar or Contour Advance electrode. Electrode types were compared using intraoperative electrode impedances, evoked compound action potential (ECAP) and stapedius reflex thresholds, as well as position parameters from postoperative computed tomography or digital volume tomography images (medial-lateral position, electrode-to-modiolus distance, insertion angle). RESULTS: The medial-lateral position indicates a closer modiolar placement of the Slim Modiolar compared with the Contour Advance. Individual electrode contact measurements, however, showed significantly larger electrode-to-modiolus distances and higher ECAP thresholds for the Slim Modiolar in the basal region. On contacts E20-22 the Slim Modiolar is slightly closer to the modiolus compared with the Contour Advance, but this did not result in lower ECAP thresholds. CONCLUSIONS: Perimodiolar electrodes can vary in their intracochlear position, leading to divergent electrophysiological outcomes. To detect these differences, investigations must be done for each electrode contact rather than using a global factor for the whole electrode array. While the electrode dislocation rate is lower with the Slim Modiolar than with the Contour Advance, electrode-to-modiolus proximity is smaller and ECAP thresholds are lower with the Contour Advance in the basal cochlear region.

Impact to the head increases cochlear implant reimplantation rate in children.

OBJECTIVE: To describe the outcome of cochlear implantation in children and to discuss the cause and management of cochlear reimplantation. STUDY DESIGN: Retrospective chart review. METHODS: The medical records of 110 patients younger than 18 years of age, who underwent cochlear implantation at the Department of ORL, Head and Neck Surgery, of the University of Kiel, Germany, were reviewed for demographics, complications, and history of revision surgery. The patients had previously had implantation with either Nucleus (including the Contour) devices or MED-EL devices. RESULTS: Length of use before cochlear explanation ranged from 4 days to 3.9 years. Reimplantation was caused by traumatic device failure, wrong electrode insertion and infection of implanted area. Results indicated a reimplantation rate of 5.4% in children compared to 0.8% in adults, mostly resulting from the greater risk of children receiving an impact to the head. Postoperative performance data showed no decrease in scores taken before failure. CONCLUSIONS: Though young children who are developing their motor skills are probably at greater risk of a cochlear reimplantation resulting from device failure following head trauma, surgical revision with reimplantation can be performed safely and without decrement to performance.

Round window membrane insertion with perimodiolar cochlear implant electrodes.

OBJECTIVE: The round window membrane (RWM) approach is designed to provide an atraumatic approach to scala tympani implantation with the goal of enhanced preservation of hearing and vestibular receptor function. Perimodiolar electrode designs offer advantages in electrophysiologic testing. However, perimodiolar arrays have only been investigated in insertion trials using temporal bone material. The aim of the present study was to evaluate perimodiolar electrode placement in a clinical trial. MATERIALS AND METHODS: The prospective nonrandomized study included 27 patients (October 2010 to February 2011). Due to the RWM approach, cochlear implantation electrode insertion was performed using a perimodiolar electrode array fitted with a stylet that enables movement through the first cochlear turn by withdrawing the stylet. We judged the feasibility of RWM approaches with perimodiolar electrodes and the electrode placement using flat panel detector radiography. Hearing preservation, vestibular receptor function (vestibular evoked myogenic potentials, subjective haptic vertical, and caloric irrigation), and subjective vertigo were evaluated in all RWM approaches. RESULTS: For anatomic reasons, RWM insertions were possible in 21 cases (78%). The basilar membrane disruption rate was 19% in RWM insertions using perimodiolar electrodes. In those patients with the electrode position within the scala tympani, vestibular receptor functions and subjective vertigo remained unchanged. The residual hearing preservation was unsatisfactory. The mean pure-tone average loss was 21 dB. CONCLUSION: We believe that if performed regularly, the RWM insertion technique has almost no negative effects on vestibular receptor function and produces no vertigo. However, cochlear hair cells may be more sensitive to electrode insertion traumas than vestibular receptor cells. The use of perimodiolar electrodes may require more atraumatic electrodes to achieve hearing preservation.