Patient-Led Research to Develop a Training Programme for Restoring Musical Joy in Cochlear Implant Recipients: A Reflexive Process Evaluation.

BACKGROUND: The role of patients in healthcare research is slowly evolving, although patient roles in the research process are limited. This paper reports on a patient-led research project aiming to develop a musical hearing training programme for patients with a cochlear implant (CI): the Musi-CI programme. A CI is an inner ear prosthesis that allows people with severe hearing loss to hear. However, while speech can be understood, CI users cannot fully enjoy music or feel aversion to it. The Musi-CI programme aims to reduce this music aversion to ultimately improve music enjoyment and social participation. The development of the Musi-CI programme was supported by a consortium of professionals in CI rehabilitation and research. The aim of this paper is to describe and evaluate the Musi-CI programme development process and its impact on professional CI rehabilitation and research. METHODS: Programme development was described using a 3-layered process model of action research, distinguishing the CI user process, the healthcare professional process and the research process. To evaluate perceptions on the programme development process, consortium partners provided written comments and participated in a reflexive evaluation session that was video-recorded. Reflexive evaluation aims for collective learning and strengthening collaboration among participants. Written comments and video data were analysed using template analysis. RESULTS: The involvement of an expert by experience was perceived as challenging but rewarding for all consortium partners, opening up new perspectives on CI-rehabilitation practice and research. Data analysis revealed two themes on the programme development process, professional space and acknowledgement, and two themes on the outcomes on CI rehabilitation and research: critical reflection and paradigm shift. CONCLUSION: Experts by experience represent a different knowledge domain that may contribute to change in rehabilitation and research. PATIENT OR PUBLIC CONTRIBUTION: The development of the programme was initiated by a professional musician and CI user who organized the funding, had a leading role throughout the research process, including the write-up of the results, and co-authored this paper.

Long-Term Outcomes of Cochlear Implantation in Usher Syndrome.

OBJECTIVES: Usher syndrome (USH), characterized by bilateral sensorineural hearing loss (SNHL) and retinitis pigmentosa (RP), prompts increased reliance on hearing due to progressive visual deterioration. It can be categorized into three subtypes: USH type 1 (USH1), characterized by severe to profound congenital SNHL, childhood-onset RP, and vestibular areflexia; USH type 2 (USH2), presenting with moderate to severe progressive SNHL and RP onset in the second decade, with or without vestibular dysfunction; and USH type 3 (USH3), featuring variable progressive SNHL beginning in childhood, variable RP onset, and diverse vestibular function. Previous studies evaluating cochlear implant (CI) outcomes in individuals with USH used varying or short follow-up durations, while others did not evaluate outcomes for each subtype separately. This study evaluates long-term CI performance in subjects with USH, at both short-term and long-term, considering each subtype separately. DESIGN: This retrospective, observational cohort study identified 36 CI recipients (53 ears) who were categorized into four different groups: early-implanted USH1 (first CI at ≤7 years of age), late-implanted USH1 (first CI at ≥8 years of age), USH2 and USH3. Phoneme scores at 65 dB SPL with CI were evaluated at 1 year, ≥2 years (mid-term), and ≥5 years postimplantation (long-term). Each subtype was analyzed separately due to the significant variability in phenotype observed among the three subtypes. RESULTS: Early-implanted USH1-subjects (N = 23 ears) achieved excellent long-term phoneme scores (100% [interquartile ranges {IQR} = 95 to 100]), with younger age at implantation significantly correlating with better CI outcomes. Simultaneously implanted subjects had significantly better outcomes than sequentially implanted subjects (p = 0.028). Late-implanted USH1 subjects (N = 3 ears) used CI solely for sound detection and showed a mean phoneme discrimination score of 12% (IQR = 0 to 12), while still expressing satisfaction with ambient sound detection. In the USH2 group (N = 23 ears), a long-term mean phoneme score of 85% (IQR = 81 to 95) was found. Better outcomes were associated with younger age at implantation and higher preimplantation speech perception scores. USH3-subjects (N = 7 ears) achieved a mean postimplantation phoneme score of 71% (IQR = 45 to 91). CONCLUSIONS: This study is currently one of the largest and most comprehensive studies evaluating CI outcomes in individuals with USH, demonstrating that overall, individuals with USH benefit from CI at both short- and long-term follow-up. Due to the considerable variability in phenotype observed among the three subtypes, each subtype was analyzed separately, resulting in smaller sample sizes. For USH1 subjects, optimal CI outcomes are expected with early simultaneous bilateral implantation. Late implantation in USH1 provides signaling function, but achieved speech recognition is insufficient for oral communication. In USH2 and USH3, favorable CI outcomes are expected, especially if individuals exhibit sufficient speech recognition with hearing aids and receive ample auditory stimulation preimplantation. Early implantation is recommended for USH2, given the progressive nature of hearing loss and concomitant severe visual impairment. In comparison with USH2, predicting outcomes in USH3 remains challenging due to the variability found. Counseling for USH2 and USH3 should highlight early implantation benefits and encourage hearing aid use.

Remote Cochlear Implant Assessments: Validity and Stability in Self-Administered Smartphone-Based Testing.

OBJECTIVES: 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. DESIGN: 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. RESULTS: 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. CONCLUSIONS: 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.

Development of the Musi-CI Training, A Musical Listening Training for Cochlear Implant Users: A Participatory Action Research Approach.

A cochlear implant (CI) is a prosthesis that allows people with severe to profound hearing loss to understand speech in quiet settings. However, listening to music presents a challenge to most CI users; they often do not enjoy music or avoid it altogether. The Musi-CI training course was developed for CI users with the goal of reducing music aversion and improving music enjoyment. A consortium was established consisting of a professional musician with CI, CI rehabilitation professionals and researchers. Participatory action research (PAR) was applied to develop and evaluate the training experiences, collaborating with 37 CI users during three cycles of eight training sessions, each held over a period of 3 months. Input and feedback were collected after each training session using questionnaires, observations and focus group interviews. Almost all participants (86%) completed the training. After completing the training a large majority of participants reported increased music appreciation, increased social participation in musical settings and a positive impact on general auditory perception. The resulting Musi-CI training programme focuses on music listening skills, self-efficacy, and self-motivation. It consists of exercises intended to strengthen attention and working memory, to improve beat and rhythm perception (with online rhythm exercises) and exercises to distinguish timbre of instruments and emotion in music. A Melody Game was developed to improve pitch and melodic contour discrimination.

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.

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.

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.

Short and long term preservation of hearing thresholds corrected for natural hearing loss in cochlear implant recipients using a straight electrode.

Objectives: The aim of this study is to investigate short and long term residual hearing preservation (HP), corrected for the natural progress of hearing loss, in cochlear implant (CI) patients receiving a straight electrode array using a round window (RW) approach.Methods: A retrospective and cross-sectional analysis on patients who received a CI with a straight electrode using a RW approach (n = 60) was performed. Audiometric data were obtained at three time points, preoperatively, at first fitting, and one year or more postoperatively. The HP outcome was calculated according to the HP definition as reported by Skarzynski with a PTA of 250, 500, and 1000 Hz (PTA3) and a PTA of 250, 500, 1000, and 2000 Hz (PTA4).Results: The HP outcome at first fitting and at long term follow up fell into the partial HP category, 63.5% (PTA3) and 40.5% (PTA4), respectively according to the Skarzynski definition. A decline in pure-tone average (PTA) was found in the CI ear and in the contralateral ear over time (p < 0.05). Interaural differences remained relatively stable at all frequencies on the long term, except for the frequency 250 Hz (p < 0.05).Discussion: After the initial loss of residual hearing, the hearing thresholds of the CI ear remain relatively stable at long term follow up when corrected for the natural course of hearing loss, except at 250 Hz.Conclusion: CI candidates should be counseled on the risk of long term deterioration of the residual hearing in both the CI ear and the contralateral ear.

The evaluation of a slim perimodiolar electrode: surgical technique in relation to intracochlear position and cochlear implant outcomes.

PURPOSE: In cochlear implantation (CI), the two factors that are determined by the surgeon with a potential significant impact on the position of the electrode within the cochlea and the potential outcome, are the surgical technique and electrode type. The objective of this prospective study was to evaluate the position of the slim, perimodiolar electrode (SPE), and to study the influence of the SPE position on CI outcome. METHODS: Twenty-three consecutively implanted, adult SPE candidates were included in this prospective cohort study conducted between December 2016 and April 2019. Mean age at surgery was 59.5 years. Mean preoperative residual hearing was 92.2 dB. Intra-operative fluoroscopy and high-resolution computed tomography scans were performed to evaluate electrode position after insertion using a cochleostomy (CS) approach. Follow-up was 12 months after implantation; residual hearing (6-8 weeks) and speech perception (6-8 weeks and 12 months) were evaluated in relation to the intracochlear SPE position. RESULTS: In most patients in whom the SPE was positioned in the scala tympani residual hearing was preserved [mean absolute increase in PTA of 4.4 dB and 77.2% relative hearing preservation (RHP%)]. Translocation into the scala vestibuli occurred in 36% of the insertions, resulting in a mean absolute increase in PTA of 17.9 dB, and a RHP% of 19.2%. Participants with a translocation had poorer speech perception scores at 12-month follow-up. CONCLUSION: Given the incidence of CS-associated translocations with the SPE and the negative effect on outcome, it is advised to insert the SPE using the (extended) round window approach.

Angular Electrode Insertion Depth and Speech Perception in Adults With a Cochlear Implant: A Systematic Review.

OBJECTIVE: 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. DATA SOURCES: 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. STUDY SELECTION: 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. DATA EXTRACTION AND SYNTHESIS: 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. CONCLUSION: 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.

No Difference in Behavioral and Self-Reported Outcomes for Simultaneous and Sequential Bilateral Cochlear Implantation: Evidence From a Multicenter Randomized Controlled Trial.

Objective: 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. Design: 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). Results: 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], p < 0.001) and localization abilities (largest difference 60 degrees configuration: -44.45% [-52.15 - -36.74], p < 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. Conclusion: 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. Trial Registration: Dutch Trial Register NTR1722.

Expanding unilateral cochlear implantation criteria for adults with bilateral acquired severe sensorineural hearing loss.

OBJECTIVES: To report on a retrospective cohort study on the effects of expanding inclusion criteria for application of cochlear implants (CIs) on the performance 1-year post-implantation. METHODS: Based on pre-implantation audiometric thresholds and aided speech recognition scores, the data of 164 CI recipients were divided into a group of patients that fulfilled conservative criteria (mean hearing loss at 0.5, 1 and 2 kHz > 85 dB HL and phoneme scores with hearing aids < 30%), and the remaining group of patients that felt outside this conservative criterion. Speech recognition scores (in quiet) and quality of life (using the NCIQ) of both groups, measured at 1-year post-implantation, were compared. RESULTS: The group that felt outside the conservative criterion showed a higher phoneme score at 1-year post-implantation compared to the conservative group, suggesting that relaxed criteria have a positive influence on the speech recognition results with CI. With respect to quality of life, both groups significantly improved 1-year post-implantation. The conservative group showed a higher benefit on the advanced perception domain of the NCIQ. Based on their worse pre-implantation hearing, this was expected. CONCLUSIONS: The data suggest that relaxation of CI indication positively affects the speech recognition performance of patients with severe hearing loss. Both groups of patients showed a positive effect of CI on the quality of life. This benefit relates to communication skills and the subjective day-to-day functioning in society.

Tinnitus after Simultaneous and Sequential Bilateral Cochlear Implantation.

IMPORTANCE: There is an ongoing global discussion on whether or not bilateral cochlear implantation should be standard care for bilateral deafness. Contrary to unilateral cochlear implantation, however, little is known about the effect of bilateral cochlear implantation on tinnitus. OBJECTIVE: To investigate tinnitus outcomes 1 year after bilateral cochlear implantation. Secondarily, to compare tinnitus outcomes between simultaneous and sequential bilateral cochlear implantation and to investigate long-term follow-up (3 years). STUDY DESIGN: This study is a secondary analysis as part of a multicenter randomized controlled trial. METHODS: Thirty-eight postlingually deafened adults were included in the original trial, in which the presence of tinnitus was not an inclusion criterion. All participants received cochlear implants (CIs) because of profound hearing loss. Nineteen participants received bilateral CIs simultaneously and 19 participants received bilateral CIs sequentially with an inter-implant interval of 2 years. The prevalence and severity of tinnitus before and after simultaneous and sequential bilateral cochlear implantation were measured preoperatively and each year after implantation with the Tinnitus Handicap Inventory (THI) and Tinnitus Questionnaire (TQ). RESULTS: The prevalence of preoperative tinnitus was 42% (16/38). One year after bilateral implantation, there was a median difference of -8 (inter-quartile range (IQR): -28 to 4) in THI score and -9 (IQR: -17 to -9) in TQ score in the participants with preoperative tinnitus. Induction of tinnitus occurred in five participants, all in the simultaneous group, in the year after bilateral implantation. Although the preoperative and also the postoperative median THI and TQ scores were higher in the simultaneous group, the median difference scores were equal in both groups. In the simultaneous group, tinnitus scores fluctuated in the 3 years after implantation. In the sequential group, four patients had an additional benefit of the second CI: a total suppression of tinnitus compared with their unilateral situation. CONCLUSION: While bilateral cochlear implantation can have a positive effect on preoperative tinnitus complaints, the induction of (temporary or permanent) tinnitus was also reported. CLINICAL TRIAL REGISTRATION: Dutch Trial Register NTR1722.