Evaluation of hearing preservation in adults with a slim perimodiolar electrode.

PURPOSE: Numerous endeavors have been undertaken to preserve hearing in cochlear implant (CI) patients. Particularly, optimization of electrode array design aims at preservation of residual hearing (RH). This study examines whether a slim perimodiolar (PM) electrode array could bear the capability to preserve hearing. METHODS: A total of 47 patients underwent cochlear implantation receiving the PM electrode. (i) Patients with pure tone audiogram (PTA) thresholds better than 85 dB and/or hearing loss for Freiburg speech test numbers less than 60 dB and more than 50% maximum monosyllabic understanding were assigned to the RH group (n = 17), while all others belonged to the noRH group (n = 30). (ii) Another group implanted with a slim straight, lateral wall (LW) electrode was recruited for comparison. RESULTS: We compared 17 RH-30 noRH patients all receiving the PM electrode. RH in PM recipients decreased faster than in LW recipients. No significant differences were observed between both (RH v/s noRH) groups in NRT thresholds, Freiburg speech test and A§E® phonemes. Analogous satisfaction levels were indicated through the questionnaires in terms of sound quality, hearing in silence, noise and directional hearing in both groups. CONCLUSIONS: The results suggest that hearing preservation is influenced not only by electrode shape but various factors. This study opens an avenue for further investigations to elucidate and enumerate the causes for progressive hearing loss.

Minimizing Intracochlear Pressure: Influence of the Insertion Sheath.

OBJECTIVE: Atraumatic cochlear implantation (CI) and insertion of the electrode in particular are major goals of recent CI surgery. Perimodiolar electrode arrays need a stylet or exosheath for insertion. The sheath can influence the intracochlear pressure changes during insertion of the electrode. The aim of this study was to modify the insertion sheath to optimize intracochlear pressure changes. METHODS: In an artifical cochlear model, 7 different modified insertion sheaths were used. The intracochlear pressure was measured with a micro-optical sensor in the apical part of the model cochlea. RESULTS: Significant lower intracochlear pressure changes were observed when the apical part of the insertion sheath was either shortened or tapered. Modification of the stopper does influence the intracochlear pressure significantly. CONCLUSION: Modification of the insertion sheath leads to lower intracochlear pressure gain. The differences and impact on intracochlear pressure changes found in this study underline the importance of even subtle modifications of the electrode insertion technique.

Comparative study of two different perimodiolar and a straight cochlear implant electrode array: surgical and audiological outcomes.

PURPOSE: To compare the surgical and audiological outcomes with two perimodiolar electrode arrays (Nucleus 512-Contour Advance® y Nucleus 532-Slim Perimodiolar®) and a straight electrode array (Nucleus 422/522). METHODS: Patients were retrospectively selected from our cochlear implant program database. Only patients with a history of bilateral, sensorineural postlingually profound hearing loss who underwent cochlear implant surgery with either a N512, a N532 or a N422 were included. Throughout a year of follow-up, pure tone audiometry (PTA), speech perception, Impedances and T-C Thresholds levels were analyzed. Surgical data were also analyzed. RESULTS: 66 patients were included (19-CI532, 20-CI512 and 27-CI422). The most common type of cochlea access with the N532, N512 and N422 was through an extended round window, a promontorial cochleostomy and a pure round window, respectively. No significant differences were observed after 12 months in Mean PTA and Speech recognition. No significant differences were seen in the levels of hearing preservation at frequencies of 250 and 500. The average values of the impedances were significantly higher in the CI group N532 and N422 than in the N512. The mean values of the T and C levels were significantly lower in the CI groups N532 and N422 compared with the N512. CONCLUSIONS: No significant differences were observed after 12 months in Mean PTA and Speech recognition; however, a faster acquisition of auditory results were observed in the group of patients treated with the CI N532. The type of electrode array influences in the type of cochleostomy.

Review of electrode placement with the Slim Modiolar Electrode: identification and management.

Background - Several cochlear implant recipients experience functionality loss due to electrode array mal-positioning. The application of delicate perimodiolar electrodes has many electrophysiological advantages, however, these profiles may be more susceptible to tip fold-over. Purpose - The prompt realization of such complication following electrode insertion would be auspicious, thus the electrode could be possibly repositioned during the same surgical procedure. Methods - The authors present three tip fold-over cases, experienced throughout their work with Slim Modiolar Electrode implants. Implantations were performed through the round window approach, by a skilled surgeon. Standard intraoperative measurements (electric integrity, neural response telemetry, and electrical stapedial reflex threshold tests) were successfully completed. The electrode position was controlled by conventional radiography on the first postoperative day. Results - Tip fold-over was not tactilely sensated by the surgeon. Our subjects revealed normal intraoperative telemetry measurements, only the postoperative imaging showed the tip fold-over. Due to the emerging adverse perception of constant beeping noise, the device was replaced by a CI512 implant after 6 months in one case. In the two remaining cases, the electrode array was reloaded into a back-up sheath, and reinserted into the scala tympani successfully through an extended round window approach. Discussion - Future additional studies using the spread of excitation or electric field imaging may improve test reliability. As all of these measurements are still carried out following electrode insertion, real-time identification, unfortunately, remains questionable. Conclusion - Tip fold-over could be reliably identified by conventional X-ray imaging. By contrast, intraoperative electrophysiology was not sufficiently sensitive to reveal it.

Cochlear Implantation with the CI512 and CI532 Precurved Electrode Arrays: One-Year Speech Recognition and Intraoperative Thresholds of Electrically Evoked Compound Action Potentials.

INTRODUCTION: Precurved cochlear implant (CI) electrode arrays were developed in an attempt to improve the auditory outcome of cochlear implantation, which varies greatly. The recent CI532 (Cochlear Corp., Sydney, Australia) may offer further advantages as its electrode array is thinner than previous precurved CI electrode arrays. The aims here were to investigate 1-year postoperative speech recognition, intraoperative electrically evoked compound action potentials (ECAPs), and their possible relation in patients implanted with a CI532 or its predecessor CI512. METHODS: A retrospective analysis of data from 63 patients subjected to cochlear implantation at the Karolinska University Hospital, Sweden, was performed. Speech recognition of the implanted ear was evaluated using phonemically balanced monosyllabic Swedish words at 65 dB SPL. ECAPs were evaluated using the intraoperative ECAP threshold across ≥8 electrodes generated by the automated neural response telemetry of the CI. RESULTS: The median aided speech recognition score (SRS) 1 year after implantation was 52% (quartile 1 = 40%, quartile 3 = 60%, n = 63) and did not differ statistically significantly between patients with CI512 (n = 38) and CI532 (n = 25). The mean ECAP threshold was 188 CL (current level; SD = 15 CL, n = 54) intraoperatively and did not differ statistically significantly between patients with CI512 (n = 32) and CI532 (n = 22), but the threshold for each electrode varied more between patients with a CI512 (p < 0.0001). A higher mean ECAP threshold was associated with a worse SRS (Spearman's ρ = -0.46, p = 0.0004, n = 54). The association remained among those with a CI512 (Spearman's ρ = -0.62, p = 0.0001, n = 32) when stratified by CI electrode array. CONCLUSION: No statistically significant difference in speech recognition 1 year after cochlear implantation or in mean threshold of ECAP intraoperatively was found between patients with a CI512 and the more recent, slim CI532, but the ECAP thresholds varied more between those with a CI512. A statistically significant association between SRS and mean ECAP threshold was found, but stratified analysis suggests that the association may be true only for patients with a CI512.

Comparison of Place-versus-Pitch Mismatch between a Perimodiolar and Lateral Wall Cochlear Implant Electrode Array in Patients with Single-Sided Deafness and a Cochlear Implant.

BACKGROUND: In electric-acoustic pitch matching experiments in patients with single-sided deafness and a cochlear implant, the observed "mismatch" between perceived pitch and predicted pitch, based on the amended Greenwood frequency map, ranges from -1 to -2 octaves. It is unknown if and how this mismatch differs for perimodiolar versus lateral wall electrode arrays. OBJECTIVES: We aimed to investigate if the type of electrode array design is of influence on the electric-acoustic pitch match. METHOD: Fourteen patients (n = 8 with CI422 + lateral wall electrode array, n = 6 with CI512 + perimodiolar electrode array; Cochlear Ltd.) compared the pitch of acoustic stimuli to the pitch of electric stimuli at two test sessions (average interval 4.3 months). We plotted these "pitch matches" per electrode contact against insertion angle, calculated from high-resolution computed tomography scans. The difference between these pitch matches and two references (the spiral ganglion map and the default frequency allocation by Cochlear Ltd.) was defined as "mismatch." RESULTS: We found average mismatches of -2.2 octaves for the CI422 group and -1.3 octaves for the CI512 group. For any given electrode contact, the mismatch was smaller for the CI512 electrode array than for the CI422 electrode array. For all electrode contacts together, there was a significant difference between the mismatches of the two groups (p < 0.05). Results remained stable over time, with no significant difference between the two test sessions considering all electrode contacts. Neither group showed a significant correlation between the mismatch and phoneme recognition scores. CONCLUSION: The pitch mismatch was smaller for the perimodiolar electrode array than for the lateral wall electrode array.

Exploration of different electrode types inserted in a 3D model of a patient with incomplete partition type III inner ear malformation.

BACKGROUND: Incomplete partition type III (IP III) represents a rare malformation of the inner ear, posing challenges during cochlear implantation due to inevitable cerebrospinal fluid (CSF) leaks and the potential misplacement of electrodes within the internal auditory canal (IAC). Despite the absence of a consensus on electrode selection, literature suggests both straight and perimodiolar electrodes as viable options for proper insertion. Limited implantation series contribute to the ambiguity in electrode choice. In this study, we evaluated the insertion performance of three electrode types in a 3D model simulating an IP III patient's inner ear. METHODS: A 3D model replicating the inner ear of a patient with IP III undergoing surgery was created, incorporating a canal wall up mastoidectomy and an enlarged round window approach. Insertions were carried out using a straight electrode, a perimodiolar electrode, and a slim perimodiolar electrode, inserted through a sheath in the basal turn of the cochlea. Electrode positions were assessed after each insertion, with each type being tested 20 times. RESULTS: Successful insertion rates were 95 % for the slim perimodiolar electrode, 85 % for the perimodiolar electrode, and 75 % for the slim straight electrode. Notably, the slim perimodiolar electrode required an adapted insertion technique due to the altered cochlear position in IP III cases. Statistical analysis revealed the slim perimodiolar electrode's superiority over the slim straight electrode in achieving successful insertions. CONCLUSIONS: The 3D model of the IP III inner ear proved to be an effective tool for electrode testing and insertion training prior to surgery. Following multiple insertions in the 3D model, the slim perimodiolar electrode demonstrated the highest success rate, emphasizing its potential as the preferred choice for cochlear implantation in IP III cases.

Influence of the Electrode Array Design on Incidence of Vertigo Symptoms and Vestibular Function After Cochlear Implantation.

PURPOSE: To evaluate if a specific type of cochlear implant (CI) electrode array (EA) reveals higher rates/prevalence of vestibular symptoms and to characterize their respective relationship to intracochlear position and objective vestibular function. METHODS: This retrospective study included 71 cochlear implantations in patients older than 18 years. The electrode position within the cochlea, electrode insertion angle, and cochlear coverage were determined from postoperative multiplanar reconstructed cone-beam computed tomography scans. All device manufacturers were represented. Data related to preoperative and postoperative PTA as well as vestibular symptoms in the preoperative and postoperative stages were collected from the patient's records. RESULTS: Twelve of the 71 (16.9%) CI patients experienced vertigo symptoms in the early postoperative period. In 5 (7.0%) patients, the vertigo complaints lasted until the time of the first activation (5-6 weeks postoperative). Postoperative onset of vestibular symptoms was more often seen in patients receiving lateral wall (LW)/straight EAs (19%) compared to perimodiolar/precurved EAs (7%), but this was only a trend and no statistical significance was observed. Moreover, preoperative pathologic caloric responses (CRs) better predicted the postoperative onset of vestibular symptoms. CONCLUSION: The preoperative consideration of a complicated CI-induced vertigo is important in the counseling particularly of elderly patients. We identified some risk factors for post-CI vertigo that should be considered in the patient's counseling: preoperative pathologic CRs, the extent of surgical trauma, and possibly the use of an LW EA, regardless of the length.

Modeling and simulation of cochlear perimodiolar electrode based on composite spring-mass model.

This paper proposes, a method for the physical modeling of the perimodiolar electrode, particularly for the process of recovering its preset shape with the guide wire drawn out, based on the composite spring-mass model by employing the virtual-volumetric spring inspired from the traditional spring-mass model. Simulation experiments of modeling and virtual insertion of perimodiolar electrode were carried out. The results indicated that the mean and standard deviation of the difference between the local deformation angles of the simulated and measured sets of mass points, (1, 2, 3), (2, 3, 4), …, (13, 14, 15), were 6.34° and 5.98°, respectively. Additionally, the physical model of the perimodiolar electrode can reflect the overall morphological changes of the real perimodiolar electrode.

Cochlear implant explantation: An in vitro model to evaluate electrode explant force and trauma.

OBJECTIVES: Removal of a cochlear implant and its intracochlear electrode array is sometimes necessary, potentially causing cochlear explant trauma. Explantation typically occurs years post-implantation by which time reactive tissue has formed around the electrode. We aimed to create an in-vitro electrode explant model to examine explant forces and intracochlear trauma across multiple electrode types and insertion depths. STUDY DESIGN: An in-vitro model using gel to represent tissue surrounding the electrode was developed. Pre-curved electrodes and straight electrodes at different insertion depths (20mm, 25mm, 28mm) were explanted from the model. During explantation, explant force was measured, and high-definition videos were recorded to capture electrode exit path and gel disruption. RESULTS: Explant force patterns varied based on electrode position in the scala tympani. Explant forces did not correlate with gel disruption, which represented explant trauma. The least gel disruption occurred with pre-curved electrodes and the under-inserted straight electrode. The greatest disruption occurred with the overly inserted straight electrode. CONCLUSION: An in-vitro model using gel to mimic tissue surrounding the electrode may provide insights into potential electrode explant trauma. Explant force did not correlate with explant trauma in our model. Pre-curved electrodes and shallower insertion depth of a straight electrode resulted in the least amount of explant trauma.

Assessing the Placement of the Cochlear Slim Perimodiolar Electrode Array by Trans Impedance Matrix Analysis: A Temporal Bone Study.

New cochlear implant (CI) electrode arrays provide softer insertion dynamics; however, due to their high flexibility, the possibilities of fold-overs or intraoperative displacements must be taken into account. The position of each individual electrode can only be determined by using high-resolution computed tomography or cone-beam CT. The trans-impedance matrix test (TIM) is an electrophysiological method based on electric field imaging that can provide images of electrode position and electrode folding. OBJECTIVE: In this experimental research, we evaluated the result of TIM as a method of monitoring cochlear insertion for a precurved slim modiolar electrode array in fresh human temporal bones by analyzing the transimpedance matrix patterns and their correlation with electrode position using high-resolution computed tomography. MATERIAL AND METHODS: Sixteen slim modiolar electrode arrays were inserted into eight fresh Human Temporal Bones. Eight electrodes were inserted according to the correct methodology of insertion, and eight were intentionally folded over. After all insertions, a trans-impedance matrix analysis and a Cone Beam CT (CBCT) were performed in each temporal bone. RESULTS: If we correlated the TIM patterns with the radiological electrode position, we observed that better electrode intracochlear positions indicated more "homogeneous" TIM patterns (intracochlear voltage dropped monotonically as the distance between stimulation and recording contact increased, both toward the apex and toward the base). A correlation where fold-over was detected in the TIM results was found in all eight temporal bone radiological findings. CONCLUSIONS: Trans-Impedance Matrix patterns were correlated with the radiological CI electrode position. When a tip fold-over appeared, a matrix with a secondary ridge in addition to the primary ridge was observed in all cases. TIM can be an effective method in the control of electrode positioning.

Alteration of Vestibular Function in Pediatric Cochlear Implant Recipients.

Background: Vestibular dysfunction is a complication of cochlear implantation (CI). Reports on the evaluation of vestibular function before and after CI are limited, especially in children. We investigated the effect of CI on vestibular function in pediatric patients. Patients and Methods: We routinely evaluated vestibular function before but not immediately after CI. Therefore, patients who underwent sequential bilateral CI were enrolled in this study. Seventy-three children who underwent sequential CI from 2003 to 2020 at our hospital were included. Since the vestibular function of the first implanted ear was evaluated before the second surgery for the contralateral ear, post-CI evaluation timing differed among the cases. The evaluation included a caloric test, a cervical vestibular-evoked myogenic potential (cVEMP) test, and a damped rotation test. The objective variables included the results of these tests, and the explanatory variables included the age at surgery, cause of hearing loss, electrode type, and surgical approach used. The associations of these tests were analyzed. Results: cVEMP was the most affected after CI (36.1%), followed by the caloric test (23.6%), and damped rotation test (7.8%). Cochleostomy was significantly more harmful than a round window (RW) approach or an extended RW approach based on the results of the caloric test (p = 0.035) and damped rotation test (p = 0.029). Perimodiolar electrodes affected the caloric test results greater than straight electrodes (p = 0.041). There were no significant associations among these tests' results. Conclusions: Minimally invasive surgery in children using a round window approach or an extended round window approach with straight electrodes is desirable to preserve vestibular function after CI.

Optimal path generation in scala tympani and path planning for robotic cochlear implant of perimodiolar electrode.

In this study, a new idea of the optimal path generation method was proposed and a path planning strategy for robotic cochlear implant of perimodiolar electrode was designed. The centerline of scala tympani channel was taken as the optimal implant path of the perimodiolar electrode, which aimed to reduce the damage of the electrode to the cochlea during implantation. First, the three-dimensional cochlear model was reconstructed based on the micro-computed tomography images of cochlea, and it was re-segmented to obtain the cross sections of the scala tympani at different angles. Then, the image processing method was used to determine the central point of the scala tympani cross sections. The cubic B-spline interpolation method was used to fit these discrete central points to generate the optimal path. Finally, the coordinate information of the optimal path was combined with the stylet extraction state of perimodiolar electrode to conduct the path planning for robotic cochlear implant, and the result was sent to the robot for kinematic inverse solution to obtain the robot motion trajectory. The robotic cochlear implant experiment was performed with the model of scala tympani. The results showed that the maximum implant force based on path planning was 0.084 N, and the maximum implant force without path planning was 0.134 N. The optimal path generation and the path planning method effectively help to reduce the damage of the electrode to the cochlea.

Multi-rigid-body modeling and simulation of perimodiolar cochlear electrode arrays.

This study presented a method that decomposes perimodiolar electrodes into multi-rigid bodies for the study on the shape variation of cochlear perimodiolar electrode. The coordinates of electrode array were obtained by capturing the shape varying image of the perimodiolar electrodes with the stylet extracted. Subsequently, the increment of the angle variation and the length of each link were obtained. Fourier compensation fitting method was developed using the three fitting methods to compare and analyze the increment of the angle variation of the perimodiolar electrode multi-rigid model. This can not only ensure that the initial angle of the joint is consistent with the actual angle of the perimodiolar electrode, but also fully reflect the varying trend of the joint angle of the multi-rigid model of the perimodiolar electrode. The simulation of the shape variation of the perimodiolar electrode multi-rigid-body model was performed using this method in the ADAMS simulation platform. According to the simulation results, the precise and continuous shape variation of perimodiolar electrodes can be obtained using this method.

Precurved Cochlear Implants and Tip Foldover: A Cadaveric Imaging Study.

Objective This study aims to define a reliable protocol for radiographic identification of placement and tip foldover of newly designed precurved and straight electrodes. Study Design Prospective imaging study. Setting Academic institution. Methods Three models of cochlear implants (Cochlear, MED-EL, and Advanced Bionics) were inserted into fresh cadaveric specimens (n = 2) in 3 configurations (normal positioning in the scala tympani, intracochlear tip foldover, and placement into the vestibular system) for a total of 9 implant scenarios. Specimens were imaged with plain radiography in Stenvers projection, as well as by high-resolution computed tomography. Results Electrode placement and presence or absence of electrode tip foldover were easily identified in all 9 scenarios on plain radiography based on the described technique. Each was confirmed with high-resolution computed tomography. Plain film temporal bone images of new electrode designs with proper and improper placement are provided for reference. Conclusion A defined protocol for intraoperative plain film radiography allowed for reliable imaging of 3 newly designed cochlear implant electrodes and immediate identification of extracochlear placement and tip foldover. Findings may be used for intraoperative confirmation of electrode array placement.

Optimal electrode design: Straight versus perimodiolar.

The electrode in a cochlear implant (CI) system is a key factor in hearing performance as it is the interface between the device and the auditory pathway of the recipient. The first CI electrodes were straight and thus adopted a lateral wall position. Subsequent innovations include: perimodiolar electrodes designed to lie adjacent to the modiolar wall and thus to provide more spatially-focused stimulation of the spiral ganglion cells; shorter atraumatic straight electrodes for combined electric and acoustic (hybrid) stimulation. This paper explores the relative merits of straight and perimodiolar electrodes in the search for the optimal electrode design with reference to electrodes from Cochlear(®).