Hearing Aid Use Time Is Causally Influenced by Psychological Parameters in Mildly Distressed Patients with Chronic Tinnitus and Mild-to-Moderate Hearing Loss.

BACKGROUND: Hearing aids (HAs) can improve tinnitus-related distress (TRD) and speech-comprehension (SC) in silence or at 55 dB noise-interference (SC_55 dB) in patients with chronic tinnitus and mild-to-moderate hearing loss. However, the role of HA use time in relation to psychological, audiological, or self-reported tinnitus characteristics is under-investigated. METHODS: We examine 177 gender-stratified patients before (t1) and after an intervention comprising binaural DSLchild algorithm-based HA fitting and auditory training (t2) and at a 70-day follow up [t3]. HA use time was retrospectively retrieved (at t2) for the pre-post- and (at t3) post-follow up periods. General linear models investigated HA use time in relation to (1) general audiological, (2) tinnitus-related audiological, (3) tinnitus-related self-report, and (4) distress-related self-report indices before and after treatment, where applicable. Receiver operator characteristic analyses identified optimal HA use time for hereby-mediated treatment changes. RESULTS: At t1 and t2, psychological, but not audiological indices causally influenced prospective HA use time-except for SC_55 dB at t1, which, however, correlated with patients' anxiety, depressivity, and psychological distress levels. Correlations did not differ between patient subgroups defined by categorical tinnitus-related audiological or self-report indices. HA use time partly mediated treatment-related improvement in TRD, but not SC. Optimal use amounted to 9.5-10.5 h/day. CONCLUSIONS: An awareness of psychological influences may help clinicians facilitate HA use and, thereby, TRD improvement with hearing amplification.

DSLchild-Algorithm-Based Hearing Aid Fitting Can Improve Speech Comprehension in Mildly Distressed Patients with Chronic Tinnitus and Mild-to-Moderate Hearing Loss.

BACKGROUND: Patients with chronic tinnitus and mild-to-moderate hearing loss (HL) can experience difficulties with speech comprehension (SC). The present study investigated SC benefits of a two-component hearing therapy. METHODS: One-hundred-seventy-seven gender-stratified patients underwent binaural DSLchild-algorithm-based hearing aid (HA) fitting and conducted auditory training exercises. SC was measured at four timepoints under three noise interference conditions each (0, 55, and 65 dB): after screening (t0; without HAs), HA- fitting (t1), additional auditory training (t2), and at 70-day follow-up (t3). Repeated-measure analyses of covariance investigated the effects of HAs (t0-t1), auditory training (t1-t2), and the stability of the combined effect (t2-t3) on SC per noise interference level and HL subgroup. Correlational analyses examined associations between SC, age, and psychological indices. RESULTS: Patients showed mildly elevated tinnitus-related distress, which was negatively associated with SC in patients with mild but not moderate HL. At 0 dB, the intervention lastingly improved SC for patients with mild and moderate HL; at 55 dB, for patients with mild HL only. These effects were mainly driven by HAs. CONCLUSIONS: The here-investigated treatment demonstrates some SC-benefit under conditions of no or little noise interference. The auditory training component warrants further investigation regarding non-audiological treatment outcomes.

Hearing Therapy Improves Tinnitus-Related Distress in Mildly Distressed Patients with Chronic Tinnitus and Mild-to-Moderate Hearing Loss: A Randomized-Controlled Cross-Over Design.

BACKGROUND: The psychological effects of hearing aids and auditory training are underinvestigated. OBJECTIVE: To assess the short- and long-term effects of an industry-developed auditory training on tinnitus-related distress, perceived stress, and psychological epiphenomena in patients with chronic tinnitus and mild-to-moderate hearing loss. METHOD: One-hundred-seventy-seven gender-stratified patients were randomized to an immediate [IIG] or delayed [DIG] intervention group. Following binaural hearing aid fitting, participants completed a CD-enhanced 14-days self-study program. Applying a randomized-controlled cross-over design, psychological measures were obtained at four times: pre-treatment/wait [IIG: t1; DIG: wait], post-treatment/pre-treatment [IIG: t2; DIG: t1], follow-up/post-treatment [IIG: t3; DIG: t2], and follow-up [DIG: t3]. Between- and within-group analyses investigated treatment-related effects and their stability at a 70-day follow-up. RESULTS: Overall, distress symptom severity was mild. Unlike the DIG, the IIG showed significant improvements in tinnitus-related distress. Some psychological epiphenomena, notably anxiety, slightly improved in both groups. Within-group analyses demonstrated the stability of the tinnitus-distress-related effects, alongside uncontrolled improvements of perceived stress and mood-related symptoms at follow-up. CONCLUSIONS: The investigated hearing therapy lastingly improves tinnitus-related distress in mildly distressed patients with chronic tinnitus and mild-to-moderate hearing loss. Beneficial psychological knock-on effects deserve further investigation.

Unification of Treatments and Interventions for Tinnitus Patients (UNITI): a study protocol for a multi-center randomized clinical trial.

BACKGROUND: Tinnitus represents a relatively common condition in the global population accompanied by various comorbidities and severe burden in many cases. Nevertheless, there is currently no general treatment or cure, presumable due to the heterogeneity of tinnitus with its wide variety of etiologies and tinnitus phenotypes. Hence, most treatment studies merely demonstrated improvement in a subgroup of tinnitus patients. The majority of studies are characterized by small sample sizes, unstandardized treatments and assessments, or applications of interventions targeting only a single organ level. Combinatory treatment approaches, potentially targeting multiple systems as well as treatment personalization, might provide remedy and enhance treatment responses. The aim of the present study is to systematically examine established tinnitus therapies both alone and in combination in a large sample of tinnitus patients. Further, it wants to provide the basis for personalized treatment approaches by evaluating a specific decision support system developed as part of an EU-funded collaborative project (Unification of treatments and interventions for tinnitus patients; UNITI project). METHODS/STUDY DESIGN: This is a multi-center parallel-arm randomized clinical trial conducted at five different clinical sites over the EU. The effect of four different tinnitus therapy approaches (sound therapy, structured counseling, hearing aids, cognitive behavioral therapy) applied over a time period of 12 weeks as a single or rather a combinatory treatment in a total number of 500 chronic tinnitus patients will be investigated. Assessments and interventions are harmonized over the involved clinical sites. The primary outcome measure focuses on the domain tinnitus distress assessed via the Tinnitus Handicap Inventory. DISCUSSION: Results and conclusions from the current study might not only provide an essential contribution to combinatory and personalized treatment approaches in tinnitus but could also provide more profound insights in the heterogeneity of tinnitus, representing an important step towards a cure for tinnitus. TRIAL REGISTRATION: ClinicalTrials.gov NCT04663828 . Registered on 11 December 2020.

Towards a unification of treatments and interventions for tinnitus patients: The EU research and innovation action UNITI.

Tinnitus is the perception of a phantom sound and the patient's reaction to it. Although much progress has been made, tinnitus remains a scientific and clinical enigma of high prevalence and high economic burden, with an estimated prevalence of 10%-20% among the adult population. The EU is funding a new collaborative project entitled "Unification of Treatments and Interventions for Tinnitus Patients" (UNITI, grant no. 848261) under its Horizon 2020 framework. The main goal of the UNITI project is to set the ground for a predictive computational model based on existing and longitudinal data attempting to address the question of which treatment or combination of treatments is optimal for a specific patient group based on certain parameters. Clinical, epidemiological, genetic and audiological data, including signals reflecting ear-brain communication, as well as patients' medical history, will be analyzed making use of existing databases. Predictive factors for different patient groups will be extracted and their prognostic relevance validated through a Randomized Clinical Trial (RCT) in which different patient groups will undergo a combination of tinnitus therapies targeting both auditory and central nervous systems. From a scientific point of view, the UNITI project can be summarized into the following research goals: (1) Analysis of existing data: Results of existing clinical studies will be analyzed to identify subgroups of patients with specific treatment responses and to identify systematic differences between the patient groups at the participating clinical centers. (2) Genetic and blood biomarker analysis: High throughput Whole Exome Sequencing (WES) will be performed in well-characterized chronic tinnitus cases, together with Proximity Extension Assays (PEA) for the identification of blood biomarkers for tinnitus. (3) RCT: A total of 500 patients will be recruited at five clinical centers across Europe comparing single treatments against combinational treatments. The four main treatments are Cognitive Behavioral Therapy (CBT), hearing aids, sound stimulation, and structured counseling. The consortium will also make use of e/m-health applications for the treatment and assessment of tinnitus. (4) Decision Support System: An innovative Decision Support System will be implemented, integrating all available parameters (epidemiological, clinical, audiometry, genetics, socioeconomic and medical history) to suggest specific examinations and the optimal intervention strategy based on the collected data. (5) Financial estimation analysis: A cost-effectiveness analysis for the respective interventions will be calculated to investigate the economic effects of the interventions based on quality-adjusted life years. In this paper, we will present the UNITI project, the scientific questions that it aims to address, the research consortium, and the organizational structure.