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There is currently a lack of prospective studies comparing multiple treatment options for single-sided deafness (SSD) in terms of long-term sound localization outcomes. This randomized controlled trial (RCT) aims to compare the objective and subjective sound localization abilities of SSD patients treated with a cochlear implant (CI), a bone conduction device (BCD), a contralateral routing of signals (CROS) hearing aid, or no treatment after two years of follow-up. About 120 eligible patients were randomized to cochlear implantation or to a trial period with first a BCD on a headband, then a CROS (or vice versa). After the trial periods, participants opted for a surgically implanted BCD, a CROS, or no treatment. Sound localization accuracy (in three configurations, calculated as percentage correct and root-mean squared error in degrees) and subjective spatial hearing (subscale of the Speech, Spatial and Qualities of hearing (SSQ) questionnaire) were assessed at baseline and after 24 months of follow-up. At the start of follow-up, 28 participants were implanted with a CI, 25 with a BCD, 34 chose a CROS, and 26 opted for no treatment. Participants in the CI group showed better sound localization accuracy and subjective spatial hearing compared to participants in the BCD, CROS, and no-treatment groups at 24 months. Participants in the CI and CROS groups showed improved subjective spatial hearing at 24 months compared to baseline. To conclude, CI outperformed the BCD, CROS, and no-treatment groups in terms of sound localization accuracy and subjective spatial hearing in SSD patients. TRIAL REGISTRATION Netherlands Trial Register (https://onderzoekmetmensen.nl): NL4457, CINGLE trial. [ABSTRACT FROM AUTHOR]

Introduction: Tinnitus is a common phenomenon with an estimated prevalence of 14.4% in the adult population. The experienced severity of tinnitus varies significantly among this population. Psychological factors have been identified as major contributors to this perceived severity, and numerous studies have demonstrated a correlation between symptoms of depression and tinnitus severity. However, the assessment of tinnitus severity and depressive symptoms often relies on self-report questionnaires, which show content overlap. This can pose challenges in distinguishing both conditions and interpreting their relationship. To address these challenges, the proposed study aims to examine the overlap between tinnitus and depressive symptom questionnaires by analyzing their content based on the International Classification of Functioning, Disability and Health (ICF) framework. Methods and analysis: Six validated, multi-item, self-report questionnaires measuring perceived tinnitus severity (THI, TQ, mTQ, THQ, TRQ, TFI) and seven validated, multi-item, self-report, depressive symptom questionnaires (BDI-II, HADS-D, SDS, PHQ-9, CES-D, SCL-90-R depression subscale, DASS-42 depression subscale) will be included in the content analysis. The content of all items of these questionnaires will be linked to ICF categories and item overlap between the tinnitus and depressive symptom questionnaires will be analyzed. Discussion: By exploring the overlap between depression and tinnitus questionnaires, this study seeks to gain a better understanding of the relationship between tinnitus and depression, by distinguishing between shared content and independent constructs of symptom scores and shedding light on the factors influencing their measured severity. Ethics and dissemination: Ethical approval is not required for this study, due to the characteristics of the study design. Findings will be disseminated through peer-reviewed open access publication and scientific conferences. [ABSTRACT FROM AUTHOR]

Objectives: Single-sided deafness (SSD) is often accompanied by tinnitus, resulting in a decreased quality of life. Currently, there is a lack of high level of evidence studies comparing different treatment options for SSD regarding tinnitus reduction. This randomized controlled trial (RCT) evaluated the effect of a cochlear implant (CI), bone conduction device (BCD), contralateral routing of sound (CROS), and no treatment on tinnitus outcomes in SSD patients, with follow-up extending to 24 months. Methods: A total of 120 adult SSD patients were randomized to three groups: CI, a trial period with first a BCD on a headband, then a CROS, or vice versa. After the trial periods, patients opted for a BCD, CROS, or no treatment. At the start of follow-up, 28 patients were implanted with a CI, 25 patients with a BCD, 34 patients had a CROS, and 26 patients chose no treatment. The Tinnitus Handicap Inventory (THI), Tinnitus Questionnaire (TQ), the Visual Analog Scale (VAS), and the Hospital Anxiety and Depression Scale (HADS) were completed at baseline and at 3, 6, 12, and 24 months of follow-up. Results: The CI and BCD groups showed significantly decreased tinnitus impact scores. The CI group showed the largest decrease, which was already observed at 3 months of follow-up. Compared to the baseline, the median THI score decreased by 23 points, the TQ score by 17 points, and the VAS score by 60 points at 24 months. In the BCD group, the TQ score decreased by 9 points, and the VAS decreased by 25 points at 24 months. The HADS anxiety and depression subscale showed no indication for anxiety or depression at baseline, nor at 24 months, for all groups. Conclusion: In this RCT, SSD patients treated with a CI or BCD showed an overall decrease in tinnitus impact scores up to 24 months compared to baseline. The CI group reported a stable and the largest reduction. Cochlear implants appear to be superior to BCD and CROS, and no treatment for achieving partial or complete resolution of tinnitus in patients with SSD. [ABSTRACT FROM AUTHOR]

Background: Cochlear Implant (CI) has been shown to improve speech comprehension, sound localization and tinnitus in adults with Single-Sided-Deafness (SSD) compared to standard treatment currently available in the Dutch setting such as a CROS (Contralateral Routing of Signals) hearing device or a BCD (Bone Conduction Device). Also, for the pediatric population with SSD, CI has shown to be clinically meaningful. Because currently no information is available on the health economic effects of CI in adults and children with SSD in the Netherlands, a cost-utility analysis was conducted. Methods: We developed a Markov cohort model, for both the adult and pediatric SSD population, with three states: implant, no implant, and dead. CI was compared with the Bone Conduction Device (BCD) treatment, requiring surgery and no specific treatment. The time horizon of the model was lifelong, costs were discounted with 3% and effects with 1.5%. A societal perspective was taken, including productivity costs in the analysis, with costing data based on publicly available prices for the Netherlands. Values for clinical outcome parameters, i.e. hearing gain, and event probabilities were based on existing literature. Deterministic and probabilistic sensitivity analyses as well as scenario analyses were performed to outline uncertainty of individual and combined parameters. Results: Mean per patient costs for CI in the adult population were €194,051 (95%-CrI €177,274 to €211,108) compared to the total costs of €185,310 (95%-CrI €182,367 to €194,142) for BCD resulting in a cost difference of €8,826 (95%-CrI -€5,020 to €18,252). Compared to no treatment, the cost difference was -€25,089 (95%-CrI -€31,678 to -€6,003). Adults who were treated with CI gained 18.41 (95%-CrI 18.07 to 18.75) quality adjusted life years (QALY) whereas BCD patients gained 15.81 QALYs (95%-CrI 15.53 to 16.10), a difference of 2.60 QALYs (95%-CrI 2.15 to 3.05). The Incremental Cost Effectiveness Ratio (ICER) for adults with CI was determined to be €3,494/QALY gained. Patient without treatment gained 13.46 QALY (95%-CrI 13.20 to 13.73), a difference of 4.95 (95%-CrI 4.87 to 5.01) resulting in CI dominating no treatment. The ICER remained below the Dutch threshold of €20,000/QALY. The probabilistic sensitivity analyses confirmed the results. For children, CI dominated when compared to BCD and when compared to no treatment. Compared to BCD, CI led to a cost saving of €29,611 (95%-CrI -€126,800 to €54,375) and compared to no treatment, CI resulted in a cost saving of €57,658 (95%-CrI -€146,687 to €5,919). The incremental QALY gain compared to BCD was 7.22 (95%-CrI 4.19 to 8.55) and 26.03 (95%-CrI 20.82 to 31.06) compared to no treatment. Conclusions: Based on the results of this health economic evaluation with a Markov cohort model, it is very likely that CI is cost-effective compared to BCD and to no treatment in the Dutch adult and pediatric population with SSD. In both populations the ICER was below the Dutch cost-effectiveness threshold of €20,000/QALY. [ABSTRACT FROM AUTHOR]