Quality-assured training in the evaluation of cochlear implant electrode position: a prospective experimental study.
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ABSTRACT: 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.
SUBMITTER: Mewes A
PROVIDER: S-EPMC9121556 | biostudies-literature | 2022 May
REPOSITORIES: biostudies-literature
Publications
Quality-assured training in the evaluation of cochlear implant electrode position: a prospective experimental study.
Mewes Alexander A Burg Sebastian S Brademann Goetz G Dambon Jan Andreas JA Hey Matthias M
BMC medical education 20220520 1
<h4>Background</h4>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.<h4>Methods</h4>This prospective experimental study was conducted on a clinical training dataset comprising patients undergoing cochlear implantation with a Nucleus® CI532 Slim Modio ...[more]
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Project description:Experimental studies play an important role in establishing the safety and efficacy of cochlear implants and they continue to provide insight into a new generation of electrode arrays and stimulation strategies. One drawback has been the limited depth of insertion of an electrode array in experimental animals. We compared the insertion depth and trauma associated with the insertion of Cochlear Ltd's Hybrid-L (HL) array with a standard 8 ring array in cat cochleae. Both arrays were inserted into cadaver cochleae and an X-ray recorded their anatomical location. The implanted cochlea was serially sectioned and photographed at 300 ?m intervals for evidence of electrode insertion trauma. Subsequently two cats were chronically implanted with HL arrays and electrically-evoked potentials recorded over a three month period. Mean insertion depth for the HL arrays was 334.8° (SD = 21°; n = 4) versus 175.5° (SD = 6°; n = 2) for the standard array. This relates to ?10.5 mm and 6 mm respectively. A similar insertion depth was measured in a chronically implanted animal with an HL array. Histology from each cadaver cochleae showed that the electrode array was always located in the scala tympani; there was no evidence of electrode insertion trauma to the basilar membrane, the osseous spiral lamina or the spiral ligament. Finally, evoked potential data from the chronically implanted animals exhibited significantly lower thresholds compared with animals implanted with a standard 8 ring array, with electrical thresholds remaining stable over a three-month observation period. Cochlear Ltd's HL electrode array can be safely inserted ?50% of the length of the cat scala tympani, placing the tip of the array close to the 4 kHz place. This insertion depth is considerably greater than is routinely achieved using a standard 8-ring electrode array (?12 kHz place). The HL array evokes low thresholds that remain stable over three months of implantation. This electrode array has potential application in a broad area of cochlear implant related research.
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Project description:ObjectiveThe process of adapting to communicate with a cochlear implant (CI) is complex. The use of auditory training after cochlear implantation may help to facilitate improvements in postoperative speech recognition and quality-of-life outcomes in new adult CI recipients. However, the effectiveness of auditory training remains uncertain and long-term effects have not been examined in a large sample of new adult CI users. As such, the objective of this study was to examine the influence of common forms of auditory training on speech recognition and CI-related quality-of-life (CI-related QOL) outcomes at 1 year after cochlear implantation. We hypothesized that patients who reported use of computer-based auditory training (CBAT) would show improved speech and CIQOL-35 Profile scores at 1 year after activation of their implant, compared with their peers.DesignThis study was designed as a prospective study and was undertaken at a tertiary academic CI center. Participants included 114 adults undergoing cochlear implantation for bilateral hearing loss. Patients serially self-reported use of the following types of post-CI auditory training over their first-year postactivation: (1) face-to-face training (e.g., speech-language pathologist), (2) passive home-based training (e.g., listening to audiobooks), and (3) CBAT (e.g., self-directed software). Outcomes measures for this study included change in Consonant-Nucleus-Consonant phoneme (CNCp), CNC word (CNCw), AzBio sentences in quiet, and CIQOL-35 Profile global and domain scores from pre-CI to 12-mo post-CI.ResultsOf 114 patients, 94 (82.5%) used one or more auditory training resources. Of these, 19.3% used face-to-face training, 67.5% passive home-based training, and 46.5% CBAT. Of 114 patients, 73 had complete CIQOL data. At 12 mo, only CBAT use was associated with significantly greater improvements in global and all domain-specific CIQOL scores ( d -range = 0.72-0.87), compared with those not using CBAT. Controlling for demographics and use of multiple training resources, CBAT remained the strongest positive predictor of CIQOL improvement, with significant associations with global score (ß = 12.019[4.127,19.9]) and all domain scores at 12-mo post-CI: communication (ß = 11.937[2.456,21.318), emotional (ß = 12.293[1.827,22.759), entertainment (ß = 17.014[5.434,28.774), environment (ß = 13.771[1.814,25.727]), listening effort (ß = 12.523[2.798,22.248]), and social (ß = 18.114[7.403,28.826]). No significant benefits were noted with use of CBAT or any other form of auditory training and speech recognition scores at 12-mo post-CI ( d -range = -0.12-0.22).ConclusionsAuditory training with CBAT was associated with improved CI-related QOL outcomes at 12-mo post-CI. Given its availability and low cost, this study provides evidence to support using CBAT to improve real-world functional abilities in new adult CI recipients.
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Project description:HypothesisCochlear duct length (CDL) can be automatically measured for custom selection of cochlear implant (CI) electrode arrays.BackgroundCI electrode array selection can be influenced by measuring the CDL, which is estimated based on the length of the line that connects the round window and the lateral wall of the cochlea when passing through the modiolus. CDL measurement remains time consuming and inter-observer variability has not been studied.MethodsWe evaluate an automatic approach to directly measure the two-turn (2T) CDL using existing algorithms for localizing cochlear anatomy in computed tomography (CT). Pre-op CT images of 309 ears were evaluated. Two fellowship-trained neurotologists manually and independently measured CDL. Inter-observer variability between measurements across expert and automatic observers is assessed. Inter-observer differences for choice of electrode type are also investigated.ResultsManual measurement of CDL by experts tends to underestimate cochlea size and has high inter-observer variability, with mean absolute differences between expert CDL estimations of 1.15 mm. Our results show that this can lead to a large number of cochleae for which a different electrode array type would be selected by different observers, depending on the specific threshold value of CDL used to decide between array type.ConclusionChoosing the best CI electrode array is an important task for optimizing hearing outcomes. Manual cochleae length measurements are user-dependent, and errors impact upon the CI electrode array choice for certain patients. Measuring cochlea length automatically is less time consuming and generates more repeatable results. Our automatic approach could make use of CDL for patient-customized treatment more clinically adoptable.
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Project description:For French cochlear implant (CI) recipients, in-person clinical auditory rehabilitation is typically provided during the first few years post-implantation. However, this is often inconvenient, it requires substantial time resources and can be problematic when appointments are unavailable. In response, we developed a computer-based home training software ("French AngelSound™") for French CI recipients. We recently conducted a pilot study to evaluate the newly developed French AngelSound™ in 15 CI recipients (5 unilateral, 5 bilateral, 5 bimodal). Outcome measures included phoneme recognition in quiet and sentence recognition in noise. Unilateral CI users were tested with the CI alone. Bilateral CI users were tested with each CI ear alone to determine the poorer ear to be trained, as well as with both ears (binaural performance). Bimodal CI users were tested with the CI ear alone, and with the contralateral hearing aid (binaural performance). Participants trained at home over a one-month period (10 hours total). Phonemic contrast training was used; the level of difficulty ranged from phoneme discrimination in quiet to phoneme identification in multi-talker babble. Unilateral and bimodal CI users trained with the CI alone; bilateral CI users trained with the poorer ear alone. Outcomes were measured before training (pre-training), immediately after training was completed (post-training), and one month after training was stopped (follow-up). For all participants, post-training CI-only vowel and consonant recognition scores significantly improved after phoneme training with the CI ear alone. For bilateral and bimodal CI users, binaural vowel and consonant recognition scores also significantly improved after training with a single CI ear. Follow-up measures showed that training benefits were largely retained. These preliminary data suggest that the phonemic contrast training in French AngelSound™ may significantly benefit French CI recipients and may complement clinical auditory rehabilitation, especially when in-person visits are not possible.
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Project description:Multielectrode cochlear implants rely on differential stimulation of the cochlear nerve for presenting the brain with the spectral and timing information required to understand speech. In implant patients, the degree of overlap among cochlear nerve fibers stimulated by the different electrodes constitutes the electrode interaction. Electrode interaction degrades the spectral resolution of the implant's stimulus. We sought to define electrode interaction in a cohort of pediatric cochlear implant subjects as a function of both stimulus intensity and electrode location along the array. The 27 pediatric subjects that completed the study were implanted with either the Clarion Hi-Focus array with or without positioner, the Nucleus 24 Contour array, or the Nucleus 24 Straight array. All but two of the patients had congenital hearing loss, and none of the patients had meningitis prior to the onset of deafness. The cochlear nerve response was measured with the electrically evoked compound action potential (ECAP). A forward masking protocol was used such that a probe stimulus electrode remained fixed while a preceding masker was moved across the array. Electrode interaction was estimated by measuring the unmasked probe response minus the masked probe response. Three probe locations and three probe intensities were examined for each subject. At all probe locations, electrode interaction increased as probe intensity increased (p < 0.05). Interaction at the basal probe was less than that at either the middle or apical probe locations (p < 0.05), and significant correlation found between probe distance from the basal end of the array and electrode interaction (p < 0.001). These results demonstrate that in this cohort of pediatric subjects, electrode interaction depended on both stimulus intensity and probe location. Implications of these findings on future implant array design and current implant fitting strategies are discussed. The impact of electrode interaction on implant performance is yet to be elucidated.
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Project description:BackgroundAutomated insertion of the cochlear implant electrode array can reduce the risk of intracochlear trauma. To address this, our group previously developed a hydraulic electrode insertion device, the Cochlea Hydrodrive (CHD), which automates the process using a syringe piston driven by an infusion pump. This study aims to characterize the hydraulic actuation process of the CHD and to preclinically evaluate its design.MethodsA camera-based motion tracking test setup was developed to obtain hydraulic motion profiles. Various syringes were evaluated for their actuation properties and the optimal syringe was selected. The CHD design was adapted based on the selected syringe, incorporating a slotted stainless steel guide tube to surround the electrode during insertion. This enhanced design was tested in ex vivo insertion trials into human head specimens.ResultsThe final design of the CHD demonstrated smooth and steady motion profiles at all tested velocities (0.4 mm/s, 0.1 mm/s, 0.03 mm/s). Ex vivo insertion trials confirmed these findings, with the guide tube facilitating easy alignment of the CHD in front of the round window and preventing electrode buckling.ConclusionOur study validates that the CHD provides reliably smooth actuation properties despite its low complexity. The use of a guide tube appears promising and could further enhance the standardization of automated electrode insertion.
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Project description:ObjectivesThe goal was to investigate the relationship between the insertion angle/cochlear coverage of cochlear implant electrode arrays and post-operative speech recognition scores in a large cohort of patients implanted with lateral wall electrode arrays.MethodsPre- and post-operative cone beam computed tomography scans of 154 ears implanted with lateral wall electrode arrays were evaluated. Traces of lateral wall and electrode arrays were combined into a virtual reconstruction of the implanted cochlea. This reconstruction was used to measure insertion angles and proportional cochlear coverage. Word recognition scores and sentence recognition scores measured 12 months after implantation using electric-only stimulation were used to examine the relationship between cochlear coverage/insertion angle and implantation outcomes.ResultsPost-operative word recognition scores and the difference between post- and pre-operative word recognition scores were positively correlated with both cochlear coverage and insertion angle, however sentence recognition scores were not. A group-wise comparison of word recognition scores revealed that patients with cochlear coverage below 70% performed significantly worse than patients with coverage between 79%-82% (p = 0.003). Performance of patients with coverage above 82% was on average poorer than between 79%-82, although this finding was not statistically significant (p = 0.84). Dividing the cohort into groups based on insertion angle quadrants revealed that word recognition scores were highest above 450° insertion angle, sentence recognition scores were highest between 450° and 630° and the difference between pre- and post-operative word recognition scores was largest between 540° and 630°, however none of these differences reached statistical significance.ConclusionsThe results of this study show that cochlear coverage has an effect on post-operative word recognition abilities and the benefit patients receive from their implant. Generally, higher coverage led to better outcomes, however there were results indicating that insertion past 82% cochlear coverage may not provide an additional benefit for word recognition. These findings can be useful for choosing the optimal electrode array and thereby improving cochlear implantation outcomes on a patient-individual basis.
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Project description:ObjectivesReliable determination of cochlear implant electrode positions shows promise for clinical applications, including anatomy-based fitting of audio processors or monitoring of electrode migration during follow-up. Currently, electrode positioning is measured using radiography. The primary objective of this study is to extend and validate an impedance-based method for estimating electrode insertion depths, which could serve as a radiation-free and cost-effective alternative to radiography. The secondary objective is to evaluate the reliability of the estimation method in the postoperative follow-up over several months.DesignThe ground truth insertion depths were measured from postoperative computed tomography scans obtained from the records of 56 cases with an identical lateral wall electrode array. For each of these cases, impedance telemetry records were retrieved starting from the day of implantation up to a maximum observation period of 60 mo. Based on these recordings, the linear and angular electrode insertion depths were estimated using a phenomenological model. The estimates obtained were compared with the ground truth values to calculate the accuracy of the model.ResultsAnalysis of the long-term recordings using a linear mixed-effects model showed that postoperative tissue resistances remained stable throughout the follow-up period, except for the two most basal electrodes, which increased significantly over time (electrode 11: ~10 Ω/year, electrode 12: ~30 Ω/year). Inferred phenomenological models from early and late impedance telemetry recordings were not different. The insertion depth of all electrodes was estimated with an absolute error of 0.9 mm ± 0.6 mm or 22° ± 18° angle (mean ± SD).ConclusionsInsertion depth estimations of the model were reliable over time when comparing two postoperative computed tomography scans of the same ear. Our results confirm that the impedance-based position estimation method can be applied to postoperative impedance telemetry recordings. Future work needs to address extracochlear electrode detection to increase the performance of the method.
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Project description:Introduction and objectivesMaintaining the structural integrity of the cochlea and preserving residual hearing is crucial for patients, especially for those for whom electric acoustic stimulation is intended. Impedances could reflect trauma due to electrode array insertion and therefore could serve as a biomarker for residual hearing. The aim of this study is to evaluate the association between residual hearing and estimated impedance subcomponents in a known collective from an exploratory study.MethodsA total of 42 patients with lateral wall electrode arrays from the same manufacturer were included in the study. For each patient, we used data from audiological measurements to compute residual hearing, impedance telemetry recordings to estimate near and far-field impedances using an approximation model, and computed tomography scans to extract anatomical information about the cochlea. We assessed the association between residual hearing and impedance subcomponent data using linear mixed-effects models.ResultsThe progression of impedance subcomponents showed that far-field impedance was stable over time compared to near-field impedance. Low-frequency residual hearing demonstrated the progressive nature of hearing loss, with 48% of patients showing full or partial hearing preservation after 6 months of follow-up. Analysis revealed a statistically significant negative effect of near-field impedance on residual hearing (-3.81 dB HL per kΩ; p < 0.001). No significant effect of far-field impedance was found.ConclusionOur findings suggest that near-field impedance offers higher specificity for residual hearing monitoring, while far-field impedance was not significantly associated with residual hearing. These results highlight the potential of impedance subcomponents as objective biomarkers for outcome monitoring in cochlear implantation.
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Project description:Introduction and objectivesAmong cochlear implant candidates, an increasing number of patients are presenting with residual acoustic hearing. To monitor the postoperative course of structural and functional preservation of the cochlea, a reliable objective biomarker would be desirable. Recently, impedance telemetry has gained increasing attention in this field. The aim of this study was to investigate the postoperative course of the residual acoustic hearing and clinical impedance in patients with long electrode arrays and to explore the applicability of impedance telemetry for monitoring residual hearing.MethodsWe retrospectively analyzed records of 42 cochlear implant recipients with residual hearing covering a median postoperative follow-up of 25 months with repeated simultaneous pure tone audiometry and impedance telemetry. We used a linear mixed-effects model to estimate the relation between clinical electrode impedance and residual hearing. Besides the clinical impedance, the follow-up time, side of implantation, gender, and age at implantation were included as fixed effects. An interaction term between impedance and follow-up time, as well as subject-level random intercepts and slopes, were included.ResultsLoss of residual hearing occurred either during surgery or within the first 6 post-operative months. Electrode contacts inserted further apically (i.e., deeper) had higher impedances, independent of residual hearing. The highest impedances were measured 1 month postoperatively and gradually decreased over time. Basal electrodes were more likely to maintain higher impedance. Follow-up time was significantly associated with residual hearing. Regardless of the time, we found that a 1 kΩ increase in clinical impedance was associated with a 4.4 dB deterioration of residual hearing (p < 0.001).ConclusionPure tone audiometry is the current gold standard for monitoring postoperative residual hearing. However, the association of clinical impedances with residual hearing thresholds found in our study could potentially be exploited for objective monitoring using impedance telemetry. Further analysis including near-field related impedance components could be performed for improved specificity to local immune responses.
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