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.

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.

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.

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.

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.

Computational Audiology: New Approaches to Advance Hearing Health Care in the Digital Age.

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.

Factors Influencing Speech Perception in Adults With a Cochlear Implant.

OBJECTIVES: 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. DESIGN: 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. RESULTS: 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. CONCLUSIONS: Cochlear implantation with a precurved electrode results in a significantly higher speech perception outcome, independent of biographic factors, audiometric factors, and scalar location.

The effect of cochlear implantation on autonomy, participation and work in postlingually deafened adults: a scoping review.

PURPOSE: This scoping review examines the available evidence on the effect of unilateral cochlear implantation (CI) in adults with postlingual bilateral hearing loss on societal-related outcomes in terms of work, autonomy and participation. METHODS: Five databases were searched (Pubmed, Web of Science, Embase, PsycINFO and Cochrane Library). Publications were screened in three steps on inclusion criteria. Of the 4230 screened publications, 110 met the inclusion criteria and were assessed for data extraction regarding outcomes "work", "autonomy", "participation". Study characteristics and key findings are presented and narratively described. RESULTS: Twenty-seven publications were included and categorized into retrospective (n = 3), cross-sectional (n = 18) or prospective (n = 6) study designs. Measurement or identification of number of outcomes (no) were related to work (no = 20), participation (no = 9) and autonomy or independency (no = 10). Most studies indicated benefits of CI on these outcomes. However, some studies did not or indicated additional barriers for benefits. Eleven publications primarily aimed to study one or more of our primary outcomes. CONCLUSION: In this literature search, scientific databases are reviewed. The results indicate that there is a relatively small body of evidence regarding the effect of CI on the outcomes "work", "autonomy" and "participation". Even though there are some limitations of the current study including some overlap in outcome definitions, most included studies indicate a beneficial effect of CI on work, autonomy and participation. The lack of consensus in definitions and the small body of evidence indicates a need for additional prospective studies investigating the societal outcomes of CI in postlingually deafened adults.

Transimpedance Matrix (TIM) Measurement for the Detection of Intraoperative Electrode Tip Foldover Using the Slim Modiolar Electrode: A Proof of Concept Study.

OBJECTIVES: 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). STUDY DESIGN: Proof of concept study. SETTING: Tertiary university referral center. PATIENTS: Twenty five ears (in 22 patients) implanted consecutively with the SME. INTERVENTIONS: Following cochlear implantation, intraoperative TIM-measurement and fluoroscopy were performed. One week postoperatively, the electrode position was evaluated using Computed Tomography (CT)-imaging. MAIN OUTCOME MEASURES: Electrode array tip foldover. RESULTS: 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. CONCLUSIONS: 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.

Spatial Hearing by Bilateral Cochlear Implant Users With Temporal Fine-Structure Processing.

Several studies have demonstrated the advantages of the bilateral vs. unilateral cochlear implantation in listeners with bilateral severe to profound hearing loss. However, it remains unclear to what extent bilaterally implanted listeners have access to binaural cues, e.g., accurate processing of interaural timing differences (ITDs) for low-frequency sounds (<1.5 kHz) and interaural level differences (ILDs) for high frequencies (>3 kHz). We tested 25 adult listeners, bilaterally implanted with MED-EL cochlear implant (CI) devices, with and without fine-structure (FS) temporal processing as encoding strategy in the low-frequency channels. In order to assess whether the ability to process binaural cues was affected by fine-structure processing, we performed psychophysical ILD and ITD sensitivity measurements and free-field sound localization experiments. We compared the results of the bilaterally implanted listeners with different numbers of FS channels. All CI listeners demonstrated good sensitivity to ILDs, but relatively poor to ITD cues. Although there was a large variability in performance, some bilateral CI users showed remarkably good localization skills. The FS coding strategy for bilateral CI hearing did not improve fine-structure ITD processing for spatial hearing on a group level. However, some CI listeners were able to exploit weakly informative temporal cues to improve their low-frequency spatial perception.

Multicenter Clinical Investigation of a New Active Osseointegrated Steady-State Implant System.

OBJECTIVE: A new active transcutaneous bone conduction hearing implant system that uses piezoelectric technology has been developed: an active osseointegrated steady-state implant system (OSI). This was the first clinical investigation undertaken to demonstrate clinical performance, safety, and benefit of the new implant system. STUDY DESIGN AND SETTING: A multicenter prospective within-subject clinical investigation was conducted. PATIENTS: Fifty-one adult subjects with mixed and conductive hearing loss (MHL/CHL, n = 37) and single-sided sensorineural deafness (SSD, n = 14) were included. MAIN OUTCOME MEASURE: Audiological evaluations included audiometric thresholds, speech recognition in noise, and quiet. Hearing and health-related patient-reported outcomes (PROs; health utilities index [HUI], abbreviated profile of hearing aid benefit [APHAB], and speech, spatial of qualities of hearing scale [SSQ]), daily use, surgical and safety parameters were collected. RESULTS: Intra- and postoperative complications were few. One implant was removed before activation due to post-surgical infection. Compared with the preoperative softband tests, a significant improvement in speech recognition-in-noise was observed in the MHL/CHL group (-7.3 dB, p ≤ 0.0001) and the SSD group (-8.1 dB, p = 0.0008). In quiet, word recognition improved in the MHL/CHL group, most markedly at lower intensity input of 50 dB SPL (26.7%, p ≤ 0.0001). The results of all PROs showed a significant improvement with the new device compared with preoperative softband in the MHL/CHL group. In the SSD group significant improvements were observed in the APHAB and SSQ questionnaires. DISCUSSION: The results confirmed the clinical safety, performance, and benefit of this new treatment modality for subjects with CHL, MHL, and SSD.

Unilateral Cochlear Implants for Severe, Profound, or Moderate Sloping to Profound Bilateral Sensorineural Hearing Loss: A Systematic Review and Consensus Statements.

Importance: Cochlear implants are a treatment option for individuals with severe, profound, or moderate sloping to profound bilateral sensorineural hearing loss (SNHL) who receive little or no benefit from hearing aids; however, cochlear implantation in adults is still not routine. Objective: To develop consensus statements regarding the use of unilateral cochlear implants in adults with severe, profound, or moderate sloping to profound bilateral SNHL. Design, Setting, and Participants: This study was a modified Delphi consensus process that was informed by a systematic review of the literature and clinical expertise. Searches were conducted in the following databases: (1) MEDLINE In-Process & Other Non-Indexed Citations and Ovid MEDLINE, (2) Embase, and (3) the Cochrane Library. Consensus statements on cochlear implantation were developed using the evidence identified. This consensus process was relevant for the use of unilateral cochlear implantation in adults with severe, profound, or moderate sloping to profound bilateral SNHL. The literature searches were conducted on July 18, 2018, and the 3-step Delphi consensus method took place over the subsequent 9-month period up to March 30, 2019. Main Outcomes and Measures: A Delphi consensus panel of 30 international specialists voted on consensus statements about cochlear implantation, informed by an SR of the literature and clinical expertise. This vote resulted in 20 evidence-based consensus statements that are in line with clinical experience. A modified 3-step Delphi consensus method was used to vote on and refine the consensus statements. This method consisted of 2 rounds of email questionnaires and a face-to-face meeting of panel members at the final round. All consensus statements were reviewed, discussed, and finalized at the face-to-face meeting. Results: In total, 6492 articles were identified in the searches of the electronic databases. After removal of duplicate articles, 74 articles fulfilled all of the inclusion criteria and were used to create the 20 evidence-based consensus statements. These 20 consensus statements on the use of unilateral cochlear implantation in adults with SNHL were relevant to the following 7 key areas of interest: level of awareness of cochlear implantation (1 consensus statement); best practice clinical pathway from diagnosis to surgery (3 consensus statements); best practice guidelines for surgery (2 consensus statements); clinical effectiveness of cochlear implantation (4 consensus statements); factors associated with postimplantation outcomes (4 consensus statements); association between hearing loss and depression, cognition, and dementia (5 consensus statements); and cost implications of cochlear implantation (1 consensus statement). Conclusions and Relevance: These consensus statements represent the first step toward the development of international guidelines on best practices for cochlear implantation in adults with SNHL. Further research to develop consensus statements for unilateral cochlear implantation in children, bilateral cochlear implantation, combined electric-acoustic stimulation, unilateral cochlear implantation for single-sided deafness, and asymmetrical hearing loss in children and adults may be beneficial for optimizing hearing and quality of life for these patients.

Impact of cochlear implantation on the function of the three semicircular canals.

OBJECTIVE: To assess the effect of cochlear implantation on the function of the semicircular canals (SCC) and on experienced vestibular symptoms. Second, to determine the relation between vestibular test results. DESIGN: Retrospective cohort study assessing absolute and categorised results of caloric irrigation test, video Head Impulse Test (vHIT) and Dizziness Handicap Inventory (DHI) before and after cochlear implantation.Study sample: 192 patients, aged ≥7 years old, without preoperative areflexia. RESULTS: Mean maximum slow phase velocity decreased with 3.1°/s and 4.7°/s for warm and cold caloric irrigation respectively. About 37.4% of the patients deteriorated one or more categories on caloric testing. Complete caloric postoperative areflexia was found in 6.2%. Mean vHIT gain decreased with 0.06, 0.04 and 0.05 for anterior, lateral and posterior SCC, respectively. Seven patients (7.7%) acquired an abnormal gain value for the anterior SCC. Only mean score on DHI's physical subdomain rose significantly (1.4 points). Overall, 9.0% of the patients deteriorated one or two categories on DHI. Only few weak correlations were found between caloric test, vHIT and DHI shifts. CONCLUSIONS: Although mean objective and subjective-physical vestibular deteriorations were significant, its clinical impact seems limited. However, 9% of patients experience vestibular deterioration, thus, advocate assessment. Vestibular test results show no or merely weak mutual correlations.