Long-Term Outcomes of a Percutaneous Wide-Diameter Bone-Anchored Hearing Implant: A Clinical Evaluation of More than 800 Implants.

OBJECTIVE: This study evaluates the clinical outcomes of 807 percutaneous wide-diameter bone-anchored hearing implants (BAHIs) in 701 patients. In addition, it compares patient groups and examines bone conduction device (BCD) usage. STUDY DESIGN: Retrospective cohort study. Mean follow-up period of 3.8 years. SETTING: Tertiary referral center. PATIENTS: All patients implanted with a percutaneous wide-diameter BAHI until December 2020 were included. Patients were divided into age groups, "loading-time" groups, and, if applicable, specific subgroups thought to be at risk for complications postsurgery, e.g., intellectual disability and comorbidities. MAIN OUTCOME MEASURES: Soft tissue reaction, implant survival, revision surgery, and BCD usage. RESULTS: In 9.1% of the 5,188 observations of 807 implants, an adverse soft tissue reaction was reported according to the Holgers' scale. Significantly more (adverse) soft tissue reactions were observed in children and intellectually disabled (ID) patients (p < 0.05). Comorbidity subgroups showed no significant differences in soft tissue reactions. Implant loss percentage, including explantations, was 6.2%. Implant survival was significantly worse in patients with ID (14.1%; p = 0.021). Pediatric age, early loading, or comorbidities did not significantly influence implant survival. At least 592 implants (73.4%) were used for bone conduction hearing, of which 65.4% were used daily. CONCLUSION: Both children and ID patients are more prone to (adverse) soft tissue reactions, ID patients only have a higher risk of implant loss. The rate of implant loss in children seemed to be reduced compared to previous studies and thus more comparable to adults since using wide-diameter implants.

Surgical Treatment for Troublesome Mastoid Cavities: Canal Wall Reconstruction With Bony Obliteration Versus Subtotal Petrosectomy.

INTRODUCTION: A chronically discharging modified radical mastoid cavity may require surgical intervention. We aim to explore two techniques. OBJECTIVE: To compare outcomes of subtotal petrosectomy (STP) and canal wall reconstruction with bony obliteration technique (CWR-BOT). STUDY DESIGN: Retrospective cohort study. SETTING: A tertiary referral center. PATIENTS: All patients with a chronically discharging mastoid cavity surgically treated at the Radboud University Medical Center by STP or CWR-BOT in 2015 to 2020, excluding patients with preoperative cholesteatoma. MAIN OUTCOME MEASURES: Dry ear rate, audiometry, and rehabilitation. SECONDARY OUTCOME MEASURES: Healing time, number of postoperative visits, complications, cholesteatoma, and need for revision surgeries. RESULTS: Thirty-four (58%) patients underwent STP, and 25 (42%) CWR-BOT. A dry ear was established in 100% of patients (STP) and 87% (CWR-BOT). The air-bone gap (ABG) increased by 12 dB in STP, and decreased by 11 dB in CWR-BOT. Postoperative ABG of CWR-BOT patients was better when preoperative computed tomography imaging showed aerated middle ear aeration. ABG improvement was higher when ossicular chain reconstruction took place. Mean follow-up time was 32.5 months (STP) versus 40.5 months (CWR-BOT). Healing time was 1.2 months (STP) versus 4.1 months (CWR-BOT). The number of postoperative visits was 2.5 (STP) versus 5 (CWR-BOT). Cholesteatoma was found in 15% (STP) versus 4% (CWR-BOT) of patients. Complication rate was 18% (STP) and 24% (CWR-BOT) with a need for revision in 21% (STP) and 8% (CWR-BOT), including revisions for cholesteatoma. CONCLUSION: STP and CWR-BOT are excellent treatment options for obtaining a dry ear in patients with a chronically discharging mastoid cavity. This article outlines essential contributing factors in counseling patients when opting for one or the other. Magnetic resonance imaging with diffusion-weighted imaging follow-up should be conducted at 3 and 5 years postoperatively.

Post-implantation clinical cost analysis between transcutaneous and percutaneous bone conduction devices.

INTRODUCTION: Bone conduction devices (BCD) are effective for hearing rehabilitation in patients with conductive and mixed hearing loss or single-sided deafness. Transcutaneous bone conduction devices (tBCD) seem to lead to fewer soft tissue complications than percutaneous BCDs (pBCD) but have other drawbacks such as MRI incompatibility and higher costs. Previous cost analyses have shown a cost advantage of tBCDs. The purpose of this study is to compare long-term post-implantations costs between percutaneous and transcutaneous BCDs. MATERIALS AND METHODS: Retrospective data from 77 patients implanted in a tertiary referral centre with a pBCD (n = 34), tBCD (n = 43; passive (tpasBCD; n = 34) and active (tactBCD; n = 9) and a reference group who underwent cochlear implantation (CI; n = 34), were included in a clinical cost analysis. Post-implantation costs were determined as the sum of consultation (medical and audiological) and additional (all post-operative care) costs. Median (cumulative) costs per device incurred for the different cohorts were compared at 1, 3 and 5 years after implantation. RESULTS: After 5 years, the total post-implantation costs of the pBCD vs tpasBCD were not significantly different (€1550.7 [IQR 1174.6-2797.4] vs €2266.9 [IQR 1314.1-3535.3], p = 0.185), nor was there a significant difference between pBCD vs tactBCD (€1550.7 [1174.6-2797.4] vs €1428.8 [1277.3-1760.4], p = 0.550). Additional post-implantation costs were significantly highest in the tpasBCD cohort at all moments of follow-up. CONCLUSION: Total costs related to post-operative rehabilitation and treatments are comparable between percutaneous and transcutaneous BCDs up to 5 years after implantation. Complications related to passive transcutaneous bone conduction devices appeared significantly more expensive after implantation due to more frequent explantations.

Human Histology after Structure Preservation Cochlear Implantation via Round Window Insertion.

OBJECTIVES: Current surgical techniques aim to preserve intracochlear structures during cochlear implant (CI) insertion to maintain residual cochlear function. The optimal technique to minimize damage, however, is still under debate. The aim of this study is to histologically compare insertional trauma and intracochlear tissue formation in humans with a CI implanted via different insertion techniques. METHODS: One recent temporal bone from a donor who underwent implantation of a full-length CI (576°) via round window (RW) insertion was compared with nine cases implanted via cochleostomy (CO) or extended round window (ERW) approach. Insertional trauma was assessed on H&E-stained histological sections. 3D reconstructions were generated and virtually re-sectioned to measure intracochlear volumes of fibrosis and neo-ossification. RESULTS: The RW insertion case showed electrode translocation via the spiral ligament. 2/9 CO/ERW cases showed no insertional trauma. The total volume of the cochlea occupied by fibro-osseous tissue was 10.8% in the RW case compared with a mean of 30.6% (range 8.7%-44.8%, N = 9) in the CO/ERW cases. The difference in tissue formation in the basal 5 mm of scala tympani, however, was even more pronounced when the RW case (12.3%) was compared with the cases with a CO/ERW approach (mean of 93.8%, range 81% to 100%, N = 9). CONCLUSIONS: Full-length CI insertions via the RW can be minimally traumatic at the cochlear base without inducing extensive fibro-osseous tissue formation locally. The current study further supports the hypothesis that drilling of the cochleostomy with damage to the endosteum incites a local tissue reaction. LEVEL OF EVIDENCE: 4: Case-control study Laryngoscope, 134:945-953, 2024.

The relation between cochlear implant programming levels and speech perception performance in post-lingually deafened adults: a data-driven approach.

PURPOSE: Programming a cochlear implant (fitting) is an essential part of a user's post-implantation journey, defining how sound will be translated into electrical stimulation and aiming to provide optimal speech perception outcomes. Currently, there are no established, evidence-based guidelines for fitting cochlear implant users, leading to a high degree of variability in fitting practices, users' parameters, and probably outcomes. In this study a data-driven approach is used to retrospectively investigate the relation between cochlear implant fitting parameters and speech perception outcomes in post-lingually deafened adults. METHODS: 298 data points corresponding to fitting parameters and speech audiometry test results for the same number of adult, post-lingually deafened, experienced CI users were analyzed. Correlation analysis was performed, after which parameters from the top-scoring and bottom-scoring tertiles were compared via the Mann-Whitney-Wilcoxon u test. RESULTS: Weak correlations between dynamic range and speech audiometry outcomes were identified, having p values lower than (albeit close to) 0.05. A significant (p < 0.05) difference in electrical dynamic range (the difference between the minimum and maximum amount of current which may be delivered by each electrode) was found, with top-scoring subjects having on average a wider dynamic range. CONCLUSION: The association between dynamic range and speech perception outcomes shown in this retrospective study highlights the need for deeper investigation into evidence-driven fitting. It might be a first step in the direction of evidence-based fitting, minimizing variability in outcomes for cochlear implant users and helping mitigate the issue of unexplained low performance.

Phoneme Training for Adult Cochlear Implant Users: A Review of the Literature and Study Protocol.

PURPOSE: This study describes a protocol for a novel individualized phoneme training program for adult cochlear implant (CI) users, based on individual phoneme confusion errors. The protocol is underpinned by a literature review on phoneme training and a focus group with adult CI users. METHOD: After a literature search, five studies were included for review and evaluation of quality and level of evidence. A focus group with experienced adult CI users (n = 7) was then conducted to gain insights into their experiences of auditory training post-implantation and recommendations for future training programs. The knowledge gained from the literature review and focus group was used as the foundation for a novel, individualized phoneme training program for adult CI users, for which the protocol is described in this study. RESULTS: A review of the literature shows that phoneme training in adult CI users has variable outcomes for on-task and off-task measures. Overall, the concept of individualized training relates to adaptive difficulty within training tasks and not to tailoring training content to participants' individual needs, as indicated by clinical outcomes. The focus group revealed that participants want to be able to track their training progress, have training content tailored to their individual needs, and expressed a preference for shorter training sessions. CONCLUSIONS: Using learnings from a literature review and focus group, this study describes a protocol for a novel, individualized phoneme training program for adult CI users. Study findings from this phoneme training program will be disseminated when available. SUPPLEMENTAL MATERIAL: https://doi.org/10.23641/asha.24392863.

Variability in clinicians' prediction accuracy for outcomes of adult cochlear implant users.

OBJECTIVE: The variability in outcomes among adult cochlear implant (CI) users poses challenges for clinicians in accurately predicting the benefits of the implant for individual candidates. This study aimed to investigate the accuracy and confidence of clinicians in predicting speech perception outcomes for adult CI users one-year post-implantation. DESIGN: Participants were presented with comprehensive information on pre-implantation, one-month post-implantation, and six-month post-implantation data for 10 case studies. The cases encompassed a range of one-year post-implantation phoneme scores, from low performers (27%) to high performers (92%). Participants were tasked with predicting the speech perception outcomes for these cases one year after implantation. STUDY SAMPLE: Forty-one clinicians completed the full outcome prediction survey. RESULTS: Our findings revealed a significant over-prediction of low performance by clinicians. Interestingly, clinicians tended to predict average performance (73-76% phoneme score) even when provided with information suggesting lower-than-average performance. Most clinicians expressed confidence in their predictions, irrespective of their accuracy. CONCLUSIONS: Identifying signs of low performance, particularly in the early post-implantation period, can enable clinicians to implement early interventions. Further research into accurate outcome prediction is essential for managing expectations, providing counselling, increasing CI adoption, and optimising clinical care for both high and low performers.

Changes on clinical and participatory outcomes in people with severe-to-profound hearing loss after cochlear implantation: protocol of a multicentre prospective observational cohort study - Societal Merit of Intervention on Hearing Loss Evaluation (SMILE).

INTRODUCTION: Cochlear implantation (CI) is a (cost-)effective intervention for people with severe or profound hearing loss. Since its introduction experience increased and the technology evolved, leading to better results and relaxation of CI eligibility criteria. Meanwhile, with national healthcare costs increasing there is a need for evidence of healthcare technology's value. This protocol describes a study to investigate clinical and participatory outcomes after CI for the currently (expanded) eligible hearing impaired population. The study adds to the current evidence base through its multicentre design, long-term follow-up and use of participatory outcomes alongside standard clinical outcomes. METHODS: This multicentre prospective observational cohort study will include at least 156 adult patients with severe-to-profound hearing loss, approximately evenly divided into two groups (1, ages 18-65 years and 2, age >65 years). The measurements consist of audiometry, cognition tests, listening effort tests and multiple generic and disease specific questionnaires. Questionnaires will be administered twice before CI, soon after inclusion at CI referral and shortly before CI surgery, with an annual follow-up of 3 years after CI. The Impact on Participation and Autonomy questionnaire will be used to assess participation. Generalised models (linear, logistic, Poisson) will be used. Mixed effects models will be used to investigate changes over time while exploring differences in subgroups and the influence of covariates. ETHICS AND DISSEMINATION: The study has received ethical approval from the Medical Ethical Committee of all participating centres. The results could provide valuable insights into changes in participatory outcomes of people with severe-to-profound hearing loss after CI. Results will be disseminated through peer-reviewed journals, scientific conferences and professional and patient organisation meetings. TRIAL REGISTRATION NUMBER: NCT05525221.

Exploring neurocognitive factors and brain activation in adult cochlear implant recipients associated with speech perception outcomes-A scoping review.

Background: Cochlear implants (CIs) are considered an effective treatment for severe-to-profound sensorineural hearing loss. However, speech perception outcomes are highly variable among adult CI recipients. Top-down neurocognitive factors have been hypothesized to contribute to this variation that is currently only partly explained by biological and audiological factors. Studies investigating this, use varying methods and observe varying outcomes, and their relevance has yet to be evaluated in a review. Gathering and structuring this evidence in this scoping review provides a clear overview of where this research line currently stands, with the aim of guiding future research. Objective: To understand to which extent different neurocognitive factors influence speech perception in adult CI users with a postlingual onset of hearing loss, by systematically reviewing the literature. Methods: A systematic scoping review was performed according to the PRISMA guidelines. Studies investigating the influence of one or more neurocognitive factors on speech perception post-implantation were included. Word and sentence perception in quiet and noise were included as speech perception outcome metrics and six key neurocognitive domains, as defined by the DSM-5, were covered during the literature search (Protocol in open science registries: 10.17605/OSF.IO/Z3G7W of searches in June 2020, April 2022). Results: From 5,668 retrieved articles, 54 articles were included and grouped into three categories using different measures to relate to speech perception outcomes: (1) Nineteen studies investigating brain activation, (2) Thirty-one investigating performance on cognitive tests, and (3) Eighteen investigating linguistic skills. Conclusion: The use of cognitive functions, recruiting the frontal cortex, the use of visual cues, recruiting the occipital cortex, and the temporal cortex still available for language processing, are beneficial for adult CI users. Cognitive assessments indicate that performance on non-verbal intelligence tasks positively correlated with speech perception outcomes. Performance on auditory or visual working memory, learning, memory and vocabulary tasks were unrelated to speech perception outcomes and performance on the Stroop task not to word perception in quiet. However, there are still many uncertainties regarding the explanation of inconsistent results between papers and more comprehensive studies are needed e.g., including different assessment times, or combining neuroimaging and behavioral measures. Systematic review registration: https://doi.org/10.17605/OSF.IO/Z3G7W.

Cochlear Implants or Hearing Aids: Speech Perception, Language, and Executive Function Outcomes.

OBJECTIVES: We aimed to determine whether children with severe hearing loss (HL) who use hearing aids (HAs) may experience added value in the perception of speech, language development, and executive function (EF) compared to children who are hard of hearing (HH) or children who are deaf and who use cochlear implants (CIs) and would benefit from CIs over HAs. The results contribute to the ongoing debate concerning CI criteria. We addressed the following research question to achieve this aim: Do children who are HH or deaf with CIs perform better than children with severe HL with HAs with respect to auditory speech perception, and receptive vocabulary and/or EF? DESIGN: We compared two groups of children with severe HL, profound HL or deafness, with CIs or HAs, matched for gender, test age (range, 8 to 15 years), socioeconomic status, and nonverbal intelligence quotient. Forty-three children had CIs (pure-tone average at 2000 and 4000 Hz >85 dB HL), and 27 children had HAs (mean pure-tone average: 69 dB HL). We measured speech perception at the conversational level (65 dB SPL) and the soft speech perception level (45 dB SPL). We established receptive vocabulary using the Peabody Picture Vocabulary Test-III-NL. We tested EF using the Delis Kaplan Executive Function System battery and the Dutch Rey Auditory Verbal Learning Test. We employed the Mann-Whitney U test to compare data between the CI and HA groups. We used Chi-square goodness of fit tests to contrast the CI and HA group distributions with the norm data of children who are typically developing (TD). We harnessed Kendall's Tau-b to investigate relationships between the study variables. RESULTS: Both groups of children, with CIs and Has, obtained ceiling scores for perception of speech on a conversational level. However, the HA group exhibited significantly lower perception on a soft speech level scores (68 %) than the CI group (87%). No difference was present between the receptive vocabulary distributions of the CI and HA groups. The median receptive vocabulary standard scores for both groups were well within the normal range (CI group: 93; HA group: 96). In addition, we did not find any difference in EF between the CI and HA groups. For planning and verbal memory, the distributions of observed scores for children with CIs were different from the expected distributions of children who are TD. In both groups, a large proportion of children obtained below-average scores for planning (CI: 44%; HA: 33%) and for long-term verbal memory (CI: 44%; HA: 35%). In the HA group, perception at a soft speech level was associated with receptive vocabulary and planning. In the CI group, we did not find any associations. CONCLUSIONS: Both groups of children with severe and profound HL with HAs exhibit less favorable auditory perception on the soft speech level, but not at a conversational level, compared to children who are HH or deaf with CIs. Both groups, children with CIs and HAs, only exhibit more problems in planning and verbal memory than the norm groups of children who are TD. The results indicate that to obtain age-appropriate levels of receptive vocabulary and EF, the perception at the soft speech level is a necessary but not sufficient prerequisite.

Impact of Expanding Eligibility Criteria for Cochlear Implantation - Dynamic Modeling Study.

OBJECTIVES: Eligibility criteria for cochlear implantation (CI) are shifting due to technological and surgical improvements. The aim of this study was to explore the impact of further expanding unilateral CI criteria in those with severe hearing loss (HL) (61-80 dBHL) in terms of number of CI recipients, costs, quality of life, and cost-effectiveness. METHODS: A dynamic population-based Markov model was constructed mimicking the Dutch population in three age categories over a period of 20 years. Health states included severe HL (61-80 dBHL), profound HL (>81 dBHL), CI recipients, and no-CI recipients. Model parameters were based on published literature, (national) databases, expert opinion, and model calibration. RESULTS: If persons with severe HL would qualify and opt for CI similar to those with profound HL now, this would lead to a 6-7 times increase of new CI recipients and an associated increase in costs (€550 million) and QALYs (54.000) over a 20-year period (incremental cost utility ratio: 10.771 euros/QALY [2.5-97.5 percentiles: 1.252-23.171]). One-way-sensitivity analysis indicated that model outcomes were most sensitive to regaining employment, utility associated with having a CI, and costs of surgery and testing. CONCLUSION: Our findings suggest that expanding eligibility for CI to persons with severe HL could be a cost-effective use of resources. Clearly, however, it would require a significant increase in diagnostic, operative, and rehabilitative capacity. Our quantitative estimates can serve as a basis for a wider societal deliberation on the question whether such an increase can and should be pursued. LEVEL OF EVIDENCE: NA Laryngoscope, 133:924-932, 2023.

Long-Term Follow-up of a Wide-Diameter Bone-Anchored Hearing Implant: 10-Year Experience on Stability, Survival, and Tolerability of an Implant-Abutment Combination.

OBJECTIVE: To compare stability, survival, and soft tissue reactions between a wide-diameter (test) and previous-generation small-diameter (control) bone-anchored hearing implant and to ascertain the safety of loading the test implant 3 weeks after surgery, at a long-term follow-up of 10 years. STUDY DESIGN: This study is a continuation of two previously completed, multicenter, randomized, controlled trials and consisted of one to two additional follow-up visits until 10 years after surgery. PATIENTS: Fifty-one of the 72 participants from the previous trials were included. Patients received a test or control implant. All control implants were loaded 6 weeks after surgery (group A). Test implants were loaded 3 (group B) or 6 weeks (group C) after surgery. RESULTS: The test implant showed significantly higher implant stability quotient (ISQ) values than the control implant throughout the 10-year follow-up. At 10 years, the mean ISQ-high values for both implants were higher than at the first follow-up visit. No significant differences in change of ISQ-high from baseline to 10 years were noticed between both implants and loading groups. Soft tissue reactions were rarely seen. At 10-year follow-up, no patients presented with adverse soft tissue reactions. Excluding explantations, the implant survival rate was 78.6% (group A), 100% (group B), and 90.0% (group C). CONCLUSIONS: The test implant showed superior mean ISQ values and significantly better implant survival throughout 10-year follow-up. In addition, the current study concludes that it is safe to load the test implant at 3 weeks after surgery, as long-term results show high ISQ values and good implant survival.

Intracochlear electrode array position and cochlear implant outcomes using the nucleus slim modiolar electrode and the extended round window approach: a follow-up study.

PURPOSE: The aim of this study was to evaluate the intracochlear position of the Slim Modiolar Electrode (SME) after insertion via the extended Round Window (eRW) approach, and to correlate this with residual hearing preservation and speech perception outcomes. METHODS: Twenty-three adult participants, consecutively implanted with the SME via the eRW approach, were included in this prospective, single-center, observational study. Electrode position was evaluated intra-operatively using X-ray fluoroscopy and TIM measurement, and post-operatively using ultra-high resolution CT. Residual hearing [threshold shift in PTA between pre- and post-operative measurement, relative hearing preservation (RHP%)] and speech perception were evaluated at 2 and 12 months after surgery. RESULTS: In each of the 23 participants, complete scala tympani positioning of the electrode array could be achieved. In one participant, an initial tip fold-over was corrected during surgery. Average age at implantation was 63.3 years (SD 13.3, range 28-76) and mean preoperative residual hearing was 81.5 dB. The average post-operative PTA threshold shift was 16.2 dB (SD 10.8) at 2 months post-operatively, corresponding with a RHP% score of 44% (SD 34.9). At 12 months, the average RHP% score decreased to 37%. Postoperative phoneme scores improved from 27.1% preoperatively, to 72.1% and 82.1% at 2 and 12 months after surgery, respectively. CONCLUSION: Use of the eRW approach results in an increased likelihood of complete scala tympani insertion when inserting the SME, with subsequent excellent levels of speech perception. However, residual hearing preservation was found to be moderate, possibly as a result of the extended round window approach, emphasizing that it is not an all-purpose approach for inserting this particular electrode array.

Ultra-High-Resolution CT to Detect Intracochlear New Bone Formation after Cochlear Implantation.

Background Histopathologic studies reported that cochlear implantation, a well-established means to treat severe-to-profound sensorineural hearing loss, may induce inflammation, fibrosis, and new bone formation (NBF) with possible impact on loss of residual hearing and hearing outcome. Purpose To assess NBF in vivo after cochlear implantation with ultra-high-spatial-resolution (UHSR) CT and its implication on long-term residual hearing outcome. Materials and Methods In a secondary analysis of a prospective single-center cross-sectional study, conducted between December 2016 and January 2018, patients with at least 1 year of cochlear implantation experience underwent temporal bone UHSR CT and residual hearing assessment. Two observers evaluated the presence and location of NBF independently, and tetrachoric correlations were used to assess interobserver reliability. In addition, the scalar location of each electrode was assessed. After consensus agreement, participants were classified into two groups: those with NBF (n = 83) and those without NBF (n = 40). The association between NBF and clinical parameters, including electrode design, surgical approach, and long-term residual hearing loss, was tested using the χ2 and Student t tests. Results A total of 123 participants (mean age ± standard deviation, 63 years ± 13; 63 women) were enrolled. NBF was found in 83 of the 123 participants (68%) at 466 of 2706 electrode contacts (17%). Most NBFs (428 of 466, 92%) were found around the 10 most basal contacts, with an interobserver agreement of 86% (2297 of 2683 contacts). Associations between electrode types and surgical approaches were significant (58 of 79 participants with NBF and a precurved electrode vs 24 of 43 with NBF and a straight electrode, P = .04; 64 of 88 participants with NBF and a cochleostomy approach vs 18 of 34 with NBF and a round window approach, P = .03). NBF was least often seen in full scala tympani insertions, but there was no significant association between scalar position and NBF (P = .15). Long-term residual hearing loss was significantly larger in the group with NBF compared with the group without NBF (mean, 22.9 dB ± 14 vs 8.6 dB ± 18, respectively; P = .04). Conclusion In vivo detection of new bone formation (NBF) after cochlear implantation is possible by using ultra-high-spatial-resolution CT. Most cochlear implant recipients develop NBF, predominately located at the base of the cochlea. NBF adversely affects long-term residual hearing preservation. © RSNA, 2021 An earlier incorrect version appeared online. This article was corrected on December 8, 2021.

Intracorporeal Cortical Telemetry as a Step to Automatic Closed-Loop EEG-Based CI Fitting: A Proof of Concept.

Electrically evoked auditory potentials have been used to predict auditory thresholds in patients with a cochlear implant (CI). However, with exception of electrically evoked compound action potentials (eCAP), conventional extracorporeal EEG recording devices are still needed. Until now, built-in (intracorporeal) back-telemetry options are limited to eCAPs. Intracorporeal recording of auditory responses beyond the cochlea is still lacking. This study describes the feasibility of obtaining longer latency cortical responses by concatenating interleaved short recording time windows used for eCAP recordings. Extracochlear reference electrodes were dedicated to record cortical responses, while intracochlear electrodes were used for stimulation, enabling intracorporeal telemetry (i.e., without an EEG device) to assess higher cortical processing in CI recipients. Simultaneous extra- and intra-corporeal recordings showed that it is feasible to obtain intracorporeal slow vertex potentials with a CI similar to those obtained by conventional extracorporeal EEG recordings. Our data demonstrate a proof of concept of closed-loop intracorporeal auditory cortical response telemetry (ICT) with a cochlear implant device. This research breaks new ground for next generation CI devices to assess higher cortical neural processing based on acute or continuous EEG telemetry to enable individualized automatic and/or adaptive CI fitting with only a CI.

Bimodal Fitting and Bilateral Cochlear Implants in Children With Significant Residual Hearing: The Impact of Asymmetry in Spatial Release of Masking on Localization.

Purpose This study aimed to gain more insight into the primary auditory abilities of children with significant residual hearing in order to improve decision making when choosing between bimodal fitting or sequential bilateral cochlear implantation. Method Sound localization abilities, spatial release of masking, and fundamental frequency perception were tested. Nine children with bimodal fitting and seven children with sequential bilateral cochlear implants were included in the study. As a reference, 15 children with normal hearing and two children with simultaneous bilateral cochlear implants were included. Results On all outcome measures, the implanted children performed worse than the normal hearing children. For high-frequency localization, children with sequential bilateral cochlear implants performed significantly better than children with bimodal fitting. Compared to children with normal hearing, the left-right asymmetry in spatial release of masking was significant. When the implant was hindered by noise, bimodally fitted children obtained significantly lower spatial release of masking compared to when the hearing aid was hindered by noise. Overall, the larger the left-right asymmetry in spatial release of masking, the poorer the localization skills. No significant differences were found in fundamental frequency perception between the implant groups. Conclusions The data hint to an advantage of bilateral implantation over bimodal fitting. The extent of asymmetry in spatial release of masking is a promising tool for decision making when choosing whether to continue with the hearing aid or to provide a second cochlear implant in children with significant residual hearing.

Comparison Between Transimpedance Matrix (TIM) Measurement and X-ray Fluoroscopy for Intraoperative Electrode Array Tip Fold-Over Detection.

OBJECTIVE: The aim of this study was to compare Transimpedance Matrix (TIM-) measurement and X-ray fluoroscopy for the intraoperative detection of electrode array tip fold-over in cochlear implant recipients. STUDY DESIGN: Retrospective agreement study. SETTING: Tertiary referral hospital. PATIENTS: Forty-two patients (47 ears) consecutively implanted with the Slim Modiolar Electrode. INTERVENTIONS: Five raters, with different levels of clinical experience, individually retrospectively evaluated the TIM-heatmaps and X-ray fluoroscopy images of all patients included in this study for electrode array tip fold-over. MAIN OUTCOME MEASURES: Agreement between raters' individual evaluation and the diagnosis given during clinical intraoperative evaluation for both modalities, as well as the inter-method agreement between TIM-measurement and fluoroscopy, and the inter-rater agreement for both modalities. RESULTS: A tip fold-over was found in three of the forty-seven implantations (6.4%) included in this study. The average agreement between raters' evaluation and the intraoperative evaluation was 88% (Cohens κ = 0.378) for fluoroscopy and 99% (Cohens κ = 0.915) for TIM-measurement. Two raters misdiagnosed at least one tip fold-over as being correctly positioned when evaluating the fluoroscopy images (1/3 and 3/3, respectively). Each of the raters correctly detected all three tip fold-overs using the TIM-heatmaps. The inter-rater agreement for fluoroscopy was classified as "fair" (Fleiss' κ = 0.286), while the inter-rater agreement for TIM-measurement was classified as "near-perfect" (Fleiss' κ = 0.850). CONCLUSIONS: TIM-measurement has a high potential to replace X-ray fluoroscopy for intraoperatively detecting electrode array tip fold-over in cochlear implantation, especially in patients implanted with flexible, precurved arrays.

A Clinical Evaluation of Minimally Invasive Ponto Surgery With a Modified Drill System for Inserting Bone-Anchored Hearing Implants.

OBJECTIVE: To compare 6-months outcomes of the modified minimally invasive Ponto surgery (m-MIPS) to both the linear incision technique with soft tissue preservation (LIT-TP), and original MIPS (o-MIPS) for inserting bone-anchored hearing implants (BAHIs). STUDY DESIGN: Exploratory pilot study with one test group and two historical control groups. SETTING: Tertiary referral center. PATIENTS: In the test group, 24 patients (25 implants) were prospectively included. Each control group comprised 25 patients (25 implants) who participated in previously conducted clinical trials. INTERVENTIONS: The test group received a BAHI using m-MIPS. The two control groups underwent surgery using the LIT-TP and o-MIPS, respectively. MAIN OUTCOME MEASURES: Implant survival, implant stability, and surgery-related variables were compared between the test and control groups. Soft tissue status, skin sensibility, and subjective numbness were compared between m-MIPS and LIT-TP only. RESULTS: Implant survival was comparable between m-MIPS and LIT-TP, whereas implant stability measurements were slightly lower for m-MIPS. M-MIPS resulted in comparable adverse skin reactions and skin sensibility, significantly reduced surgical time and slightly improved subjective numbness, compared with LIT-TP. Between m-MIPS and o-MIPS, no statistically significant differences in implant survival, implant stability and surgical time were observed. CONCLUSIONS: A trend toward lower implant loss rates after m-MIPS was observed, when compared with o-MIPS. M-MIPS seems to be a good alternative to LIT-TP for inserting BAHIs, since most clinical outcomes were either comparable or slightly better for m-MIPS. Upon deciding on which technique to use, larger studies on implant survival should be performed. Furthermore, other aspects such as costs, training aspects and surgical experience should be evaluated.