The aim of this study is to report on our preliminary experience with Transimpedance Matrix (TIM)-measurement for the detection of cochlear implant electrode tip foldovers compared with ...intraoperative imaging in patients implanted with the slim modiolar electrode (SME).
Proof of concept study.
Tertiary university referral center.
Twenty five ears (in 22 patients) implanted consecutively with the SME.
Following cochlear implantation, intraoperative TIM-measurement and fluoroscopy were performed. One week postoperatively, the electrode position was evaluated using Computed Tomography (CT)-imaging.
Electrode array tip foldover.
Electrode array tip foldover occurred in three of the 25 cochlear implantations performed (12%). In each case, the foldover was detected by both TIM and fluoroscopy, leading to reposition and correct intracochlear placement of the array.
TIM-measurement is a promising method for the intraoperative detection of an electrode array tip foldover. The TIM-tool with intuitive heatmap display is easy to use, fast, and readily available to clinics using TIM-software in the operating theatre.
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.
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.
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.
NCT05525221.
The primary aim of this study was to longitudinally compare the behavioral and self-reported outcomes of simultaneous bilateral cochlear implantation (simBiCI) and sequential BiCI (seqBiCI) in adults ...with severe-to-profound postlingual sensorineural hearing loss.
This study is a multicenter randomized controlled trial with a 4-year follow-up period after the first moment of implantation. Participants were allocated by randomization to receive bilateral cochlear implants (CIs) either, simultaneously (simBiCI group) or sequentially with an inter-implant interval of 2 years (UCI/seqBiCI group). All sequential patients where encouraged to use their hearing aid on the non-implanted ear over of the first 2 years. Patients were followed-up on an annual basis. The primary outcome was speech perception in noise coming from a source directly in front of the patient. Other behavioral outcome measures were speech intelligibility-in-noise from spatially separated sources, localization and speech perception in quiet. Self-reported outcome measures encompassed questionnaires on quality of life, quality of hearing and tinnitus. All outcome measures were analyzed longitudinally using a linear or logistic regression analysis with an autoregressive residual covariance matrix (generalized estimating equations type).
Nineteen participants were randomly allocated to the simBiCI group and 19 participants to the UCI/seqBiCI group. Three participants in the UCI/seqBiCI group did not proceed with their second implantation and were therefore unavailable for follow-up. Both study groups performed equally well on speech perception in noise from a source directly in front of the patient longitudinally. During all 4 years of follow-up the UCI/seqBiCI group performed significantly worse compared to the simBiCI group on spatial speech perception in noise in the best performance situation (8.70 dB 3.96 - 13.44,
< 0.001) and localization abilities (largest difference 60 degrees configuration: -44.45% -52.15 - -36.74,
< 0.0001). Furthermore, during all years of follow-up, the UCI/seqBiCI group performed significantly worse on quality of hearing and quality of life questionnaires. The years of unilateral CI use were the reason for the inferior results in the UCI/SeqBiCI group. One year after receiving CI2, the UCI/seqBiCI group performance did not statistically differ from the performance of the simBiCI group on all these outcomes. Furthermore, no longitudinal differences were seen in tinnitus burden prevalence between groups. Finally, the complications that occurred during this trial were infection, dysfunction of CI, facial nerve palsy, tinnitus and vertigo.
This randomized controlled trial on bilaterally severely hearing impaired participants found a significantly worse longitudinal performance of UCI/seqBiCI compared to simBiCI on multiple behavioral and self-reported outcomes regarding speech perception in noise and localization abilities. This difference is associated with the inferior performance of the UCI/seqBiCI participants during the years of unilateral CI use. After receiving the second CI however, the performance of the UCI/seqBiCI group did not significantly differ from the simBiCI group.
Dutch Trial Register NTR1722.
The stability of remote testing in cochlear implant care was studied by testing the influence of time-of-day, listener fatigue, and motivation on the outcomes of the aided threshold test (ATT) and ...digit triplets test (DTT) in cochlear implant (CI) recipients using self-tests at-home on a smartphone or tablet.
A single-center repeated measures cohort study design (n = 50 adult CI recipients). The ATT and DTT were tested at-home ten times, with nine of these sessions planned within a period of eight days. Outcomes were modeled as a function of time-of-day, momentary motivation, listeners' task-related fatigue, and chronotype (i.e., someone's preference for morning or evening due to the sleep-wake cycle) using linear mixed models. Additional factors included aided monosyllabic word recognition in quiet, daily-life fatigue, age, and CI experience.
Out of 500 planned measurements, 407 ATTs and 476 DTTs were completed. The ATT determined thresholds and impedances were stable across sessions. The factors in the DTT model explained 75% of the total variance. Forty-nine percent of the total variance was explained by individual differences in the participants' DTT performance. For each 10% increase in word recognition in quiet, the DTT speech reception threshold improved by an average of 1.6 dB. DTT speech reception threshold improved, on average by 0.1 dB per repeated session and correlated with the number of successful DTTs per participant. There was no significant time-of-day effect on auditory performance in at-home administered tests.
This study is one of the first to report on the validity and stability of remote assessments in CI recipients and reveals relevant factors. CI recipients can be self-tested at any waking hour to monitor performance via smartphone or tablet. Motivation, task-related fatigue, and chronotype did not affect the outcomes of ATT or DTT in the studied cohort. Word recognition in quiet is a good predictor for deciding whether the DTT should be included in an individual's remote test battery. At-home testing is reliable for cochlear implant recipients and offers an opportunity to provide care in a virtual hearing clinic setting.
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.
...Retrospective agreement study.
Tertiary referral hospital.
Forty-two patients (47 ears) consecutively implanted with the Slim Modiolar Electrode.
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.
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.
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).
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.
The primary objective of this study is to identify the biographic, audiologic, and electrode position factors that influence speech perception performance in adult cochlear implant (CI) recipients ...implanted with a device from a single manufacturer. The secondary objective is to investigate the independent association of the type of electrode (precurved or straight) with speech perception.
In a cross-sectional study design, speech perception measures and ultrahigh-resolution computed tomography scans were performed in 129 experienced CI recipients with a postlingual onset of hearing loss. Data were collected between December 2016 and January 2018 in the Radboud University Medical Center, Nijmegen, the Netherlands. The participants received either a precurved electrode (N = 85) or a straight electrode (N = 44), all from the same manufacturer. The biographic variables evaluated were age at implantation, level of education, and years of hearing loss. The audiometric factors explored were preoperative and postoperative pure-tone average residual hearing and preoperative speech perception score. The electrode position factors analyzed, as measured from images obtained with the ultrahigh-resolution computed tomography scan, were the scalar location, angular insertion depth of the basal and apical electrode contacts, and the wrapping factor (i.e., electrode-to-modiolus distance), as well as the type of electrode used. These 11 variables were tested for their effect on three speech perception outcomes: consonant-vowel-consonant words in quiet tests at 50 dB SPL (CVC50) and 65 dB SPL (CVC65), and the digits-in-noise test.
A lower age at implantation was correlated with a higher CVC50 phoneme score in the straight electrode group. Other biographic variables did not correlate with speech perception. Furthermore, participants implanted with a precurved electrode and who had poor preoperative hearing thresholds performed better in all speech perception outcomes than the participants implanted with a straight electrode and relatively better preoperative hearing thresholds. After correcting for biographic factors, audiometric variables, and scalar location, we showed that the precurved electrode led to an 11.8 percentage points (95% confidence interval: 1.4-20.4%; p = 0.03) higher perception score for the CVC50 phonemes compared with the straight electrode. Furthermore, contrary to our initial expectations, the preservation of residual hearing with the straight electrode was poor, as the median preoperative and the postoperative residual hearing thresholds for the straight electrode were 88 and 122 dB, respectively.
Cochlear implantation with a precurved electrode results in a significantly higher speech perception outcome, independent of biographic factors, audiometric factors, and scalar location.
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
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. Based on its outcomes, the described expansion appears to constitute a cost‐effective use of healthcare resources. However, it would require a significant increase in diagnostic, operative and rehabilitative capacity. These quantitative estimates can serve as a basis for wider societal deliberation on the question wheter such an increase can and should be pursued.
The global digital transformation enables computational audiology for advanced clinical applications that can reduce the global burden of hearing loss. In this article, we describe emerging ...hearing-related artificial intelligence applications and argue for their potential to improve access, precision, and efficiency of hearing health care services. Also, we raise awareness of risks that must be addressed to enable a safe digital transformation in audiology. We envision a future where computational audiology is implemented via interoperable systems using shared data and where health care providers adopt expanded roles within a network of distributed expertise. This effort should take place in a health care system where privacy, responsibility of each stakeholder, and patients' safety and autonomy are all guarded by design.
By discussing the design, findings, strengths, and weaknesses of available studies investigating the influence of angular insertion depth on speech perception, we intend to summarize the current ...status of evidence; and using evidence based conclusions, possibly contribute to the determination of the optimal cochlear implant (CI) electrode position.
Our search strategy yielded 10,877 papers. PubMed, Ovid EMBASE, Web of Science, and the Cochrane Library were searched up to June 1, 2018. Both keywords and free-text terms, related to patient population, predictive factor, and outcome measurements were used. There were no restrictions in languages or year of publication.
Seven articles were included in this systematic review. Articles eligible for inclusion: (a) investigated cochlear implantation of any CI system in adults with post-lingual onset of deafness and normal cochlear anatomy; (b) investigated the relationship between angular insertion depth and speech perception; (c) measured angular insertion depth on imaging; and (d) measured speech perception at, or beyond 1-year post-activation.
In included studies; quality was judged low-to-moderate and risk of bias, evaluated using a Quality-in-Prognostic-Studies-tool (QUIPS), was high. Included studies were too heterogeneous to perform meta-analyses, therefore, effect estimates of the individual studies are presented. Six out of seven included studies found no effect of angular insertion depth on speech perception.
All included studies are characterized by methodological flaws, and therefore, evidence-based conclusions regarding the influence of angular insertion depth cannot be drawn to date.
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