The out-of-pocket expenses of people with tinnitus in Europe.

BACKGROUND: Despite the high frequency of tinnitus and its impact on wellbeing, little is known about its economic burden and no data to our knowledge are available on out-of-pocket (OOP) expenses. METHODS: In 2022 a survey was conducted on OOP costs of tinnitus. We enrolled 679 participants with slight, moderate and severe tinnitus in Italy, United Kingdom, Netherlands, Germany and Spain. We estimated annual OOP expenses for tinnitus-related healthcare visits, treatments, medications and alternative medicine practices. Prevalence of tinnitus in the general population, obtained from a representative survey we conducted in Europe in 2017-2018, was used to generalise costs for people with any tinnitus at the national level. RESULTS: OOP expenses were 368€ (95% confidence intervals (CI), 78€-690€), 728€ (95% CI, 316€-1,288€), and 1,492€ (95% CI, 760€-2,688€) for slight, moderate, and severe tinnitus, respectively, with annual expenditure of 565€ for people with any tinnitus: 209€ for healthcare visits, 93€ for treatments, 16€ for drugs, 64€ for hearing supporting systems and 183€ for acupuncture, homeopathy and osteopathy. Individuals with slight, moderate, and severe tinnitus expressed a willingness to invest 1.6, 4.3, and 7.0 times their monthly income, respectively, to achieve complete relief from tinnitus. CONCLUSIONS: This study offers for the first time insights into the OOP expenses incurred by individuals with tinnitus. OOP expenses exhibited substantial variations based on severity status, accounting for more than 17 thousand million€ in the countries considered. In terms of financial burden, these findings align tinnitus to the recognised leading disabilities, including back pain and migraine.

Translation and validation of the dizziness handicap inventory in Greek language.

OBJECTIVE: The aim of the study was to test the reliability and validity of the Dizziness Handicap Inventory in the Greek language (DHI). DESIGN: This study was performed in a university tertiary centre. Internal consistency was estimated using Cronbach's alpha for the DHI, physical (DHI-P), functional (DHI-F) and emotional (DHI-E) subscale scores. Correlation between DHI (total and subscales) and the SOT (sensory organisation test) as well as correlation between the DHI and FGA (functional gait assessment) was tested using Spearman's correlation coefficient. Test-retest reliability was tested using ICC (Intraclass Correlation Coefficient). SAMPLE SIZE: Ninety (90) patients were included in the study. RESULTS: Internal consistency was excellent for the total score and very good for the physical functional and emotional subscale scores. No statistically significant correlation was found between SOT and DHI. There was a moderate correlation between FGA and total DHI scores (r = -0.472; p < 0.0001) and poor to moderate between FGA and DHI subscale scores (DHI-E r1 = -0.342; p1 = 0.001, DHI-F r2 = -0.448 p2 < 0.0001, DHI-P r3 = -0.472 p3 < 0.0001). Test-retest reliability was excellent. CONCLUSION: Greek version of DHI is recommended as a valid measure for patients with vestibular disorders.

Management and modeling of balance disorders using decision support systems: the EMBALANCE project.

In this work, we present the concept, the methodological ideas and the architecture of the EMBALANCE platform. EMBALANCE platform extends existing but generic and currently uncoupled balance modeling activities, leading to a multi-scale and patient-specific balance Hypermodel, which is incorporated to a Decision Support System (DSS), towards the early diagnosis, prediction and the efficient treatment planning of balance disorders. Various data feed the intelligent system increasing the dimensionality and personalization of the system. Human Computer Interaction techniques are utilized in order to develop the required interfaces in a user-intuitive and efficient way, while interoperable web services enhance the accessibility and acceptance of the system. The platform will be validated using both retrospective as well as prospective experimental and clinical data. The final tool will be a powerful web-based platform provided to primary and secondary care physicians across specialties, levels of training and geographical boundaries, targeting wider clinical acceptance as well as the increased confidence in the developed DSS towards the early diagnostic evaluation, behaviour prediction and effective management planning of balance problems. Currently we focus and present the management and modeling of the balance disorders.

Cognitive Screening and Hearing Assessment in Patients With Chronic Tinnitus.

OBJECTIVES: The study aimed to assess the relationship of tinnitus with hyperacusis with cognitive impairment as indicated by the Montreal Cognitive Assessment (MoCA) tool. METHODS: This multicenter cross-sectional study included individuals with chronic tinnitus from the "Unification of Treatments and Interventions for Tinnitus Patients" (UNITI) database. Participants were recruited from four different tertiary clinical centers located in Athens and Granada (Mediterranean group), as well as Berlin and Regensburg (German group). In total, 380 individuals with a diagnosis of non-pulsatile chronic tinnitus (permanent and constant tinnitus lasting more than 6 months) and no evidence of severe cognitive impairment (MoCA score >22) were enrolled. The evaluation utilized the following tools: MoCA, Tinnitus Handicap Inventory (THI), Hyperacusis Questionnaire (GÜF), Patient Health Questionnaire (PHQ-9), and the European School for Interdisciplinary Tinnitus Research Screening Questionnaire. RESULTS: MoCA scores differed between German and Mediterranean individuals (P<0.01), necessitating separate analyses for each group. In both cohorts, MoCA scores were significantly associated with education level, age, hearing threshold at 8 kHz, and THI. Furthermore, a significant correlation was observed between PHQ-9 scores and both THI and GÜF (P<0.01 for both Germans and those from the Mediterranean). CONCLUSION: Our data suggest an association between tinnitus handicap, high-frequency hearing loss, and mild cognitive impairment. Additionally, PHQ-9 scores were associated with tinnitus and hyperacusis scores, independent of hearing loss thresholds.

Can vigilance predict the status of safe functional gait and risk of falls in patients with peripheral vestibular disorders? A cross-sectional study.

OBJECTIVES: Peripheral vestibular disorders except from reflexes dysfunction correspond also to cognitive decline. The objectives of this cross-sectional study were to a) identify correlations among variables of functional gait, cognitive function, and perceived dizziness and b) explore variables that could be used as prognostic factors of functional gait in people with peripheral vestibular deficits. METHODS: We recruited 154 people with peripheral vestibular deficits. The participants presented with moderate disability in terms of the Dizziness Handicap Inventory questionnaire (mean: 48.00, 95% confidence interval: 45.24-50.75), deficits in the Functional Gait Assessment test (mean: 22.75, 95% confidence interval: 22.13-23.40) and indication of mild cognitive impairment based on Montreal Cognitive Assessment tool (mean: 25.18, 95% confidence interval: 24.75-25.60). RESULTS: Statistically significant correlations found among functional gait and gender, age, educational level, perceived level of disability and the total score of the Montreal Cognitive Assessment tool. Several components of the cognitive screening test (executive function, vigilance, language skills, verbal fluency) also correlated statistically significant with functional gait. Linear regression models revealed that age, perceived level of disability and vigilance significantly predicted functional gait variability (R2 = 0.350; p < 0.001) as well as high risk of falling, as indicated by a score on Functional Gait Assessment test <22/30 (R2 = 0.380). CONCLUSIONS: Cognitive impairments affect functional gait in people with peripheral vestibular disorders. Thus, the integration of cognitive functional assessment must be considered as a prerequisite for functional assessment and designing rehabilitation programs that will include dual task training.

Head mounted display effect on vestibular rehabilitation exercises performance.

Objectives: Vestibular rehabilitation clinical guidelines document the additional benefit offered by the Mixed Reality environments in the reduction of symptoms and the improvement of balance in peripheral vestibular hypofunction. The HOLOBalance platform offers vestibular rehabilitation exercises, in an Augmented Reality (AR) environment, projecting them using a low- cost Head Mounted Display. The effect of the AR equipment on the performance in three of the commonest vestibular rehabilitation exercises is investigated in this pilot study. Methods: Twenty-five healthy adults (12/25 women) participated, executing the predetermined exercises with or without the use of the AR equipment. Results: Statistically significant difference was obtained only in the frequency of head movements in the yaw plane during the execution of a vestibular adaptation exercise by healthy adults (0.97 Hz; 95% CI=(0.56, 1.39), p<0.001). In terms of difficulty in exercise execution, the use of the equipment led to statistically significant differences at the vestibular-oculomotor adaptation exercise in the pitch plane (OR=3.64, 95% CI (-0.22, 7.50), p=0.049), and in the standing exercise (OR=28.28. 95% CI (23.6, 32.96), p=0.0001). Conclusion: Τhe use of AR equipment in vestibular rehabilitation protocols should be adapted to the clinicians' needs.

The statistical analysis plan for the unification of treatments and interventions for tinnitus patients randomized clinical trial (UNITI-RCT).

BACKGROUND: Tinnitus is a leading cause of disease burden globally. Several therapeutic strategies are recommended in guidelines for the reduction of tinnitus distress; however, little is known about the potentially increased effectiveness of a combination of treatments and personalized treatments for each tinnitus patient. METHODS: Within the Unification of Treatments and Interventions for Tinnitus Patients project, a multicenter, randomized clinical trial is conducted with the aim to compare the effectiveness of single treatments and combined treatments on tinnitus distress (UNITI-RCT). Five different tinnitus centers across Europe aim to treat chronic tinnitus patients with either cognitive behavioral therapy, sound therapy, structured counseling, or hearing aids alone, or with a combination of two of these treatments, resulting in four treatment arms with single treatment and six treatment arms with combinational treatment. This statistical analysis plan describes the statistical methods to be deployed in the UNITI-RCT. DISCUSSION: The UNITI-RCT trial will provide important evidence about whether a combination of treatments is superior to a single treatment alone in the management of chronic tinnitus patients. This pre-specified statistical analysis plan details the methodology for the analysis of the UNITI trial results. TRIAL REGISTRATION: ClinicalTrials.gov NCT04663828 . The trial is ongoing. Date of registration: December 11, 2020. All patients that finished their treatment before 19 December 2022 are included in the main RCT analysis.

Recommendations for physical activity in the elderly population: A scoping review of guidelines.

Physical inactivity and sedentary time are associated with all-cause mortality, chronic non-communicable diseases and falls in the elderly. Objective of this review is to assess and summarize recommendations from clinical guidelines for physical activity (PA) of older adults in general and related to falls. A scoping review of the existing clinical guidelines was conducted. The included studies should have been developed under the auspices of a health organization and their methodology should be described in detail. Nine clinical guidelines providing specific recommendations for the elderly were identified. There was a strong agreement across the guidelines regarding goals, activities parameters, adverse effects of PA, in addition to reference for preventing falls. Keeping even the minimum of physical activity, introducing balance exercises and strengthening exercises for preventing falls, avoiding unexpected accelerations in the intensity of the activities, applying the necessary precautions and consulting a health professional are the main pillars of recommendations. Despite any deficiencies in definitions, monitoring and optimal dosage consistency of recommendations, is an ideal incentive for countries and organizations to adopt and enhance physical activity as an antidote to the degeneration of human's health and quality of life.

Development and Evaluation of Automated Tools for Auditory-Brainstem and Middle-Auditory Evoked Potentials Waves Detection and Annotation.

Auditory evoked potentials (AEPs) are brain-derived electrical signals, following an auditory stimulus, utilised to examine any obstructions along the brain neural-pathways and to diagnose hearing impairment. The clinical evaluation of AEPs is based on the measurements of the latencies and amplitudes of waves of interest; hence, their identification is a prerequisite for AEP analysis. This process has proven to be complex, as it requires relevant clinical experience, and the existing software for this purpose has little practical use. The aim of this study was the development of two automated annotation tools for ABR (auditory brainstem response)- and AMLR (auditory middle latency response)-tests. After the acquisition of 1046 raw waveforms, appropriate pre-processing and implementation of a four-stage development process were performed, to define the appropriate logical conditions and steps for each algorithm. The tools' detection and annotation results, regarding the waves of interest, were then compared to the clinicians' manual annotation, achieving match rates of at least 93.86%, 98.51%, and 91.51% respectively, for the three ABR-waves of interest, and 93.21%, 92.25%, 83.35%, and 79.27%, respectively, for the four AMLR-waves. The application of such tools in AEP analysis is expected to assist towards an easier interpretation of these signals.

Utilizing Co-Creative Principles to Develop an E-Learning Platform for Interprofessional Training on Tinnitus: The Erasmus+ Project Tin-TRAC.

Tinnitus treatment, diagnosis and management across Europe varies significantly. The lack of national clinical guidelines for tinnitus management in most European countries and the absence of a common language across all disciplines involved is reflected in the diversification of healthcare practices. Interprofessional Training for Tinnitus Researchers and Clinicians (Tin-TRAC) is an Erasmus+ project that aims to develop common educational ground in the form of an e-Learning platform, co-created by patients, researchers and clinicians, which is able to unify tinnitus diagnosis and treatment strategies across Europe. A pan-European thematic educational platform integrating the best practices and latest research achievements with regard to tinnitus diagnosis and management has the potential to act as a facilitator of the reduction of interdisciplinary and interregional practice diversification. A detailed analysis of the educational needs of clinicians and researchers across disciplines will be followed by the co-creative development of the curriculum. Reusable learning objects will incorporate the training contents and will be integrated in an open e-Learning platform. Tin-TRAC envisions that its output will answer the need to create a common language across the clinicians and researchers of different disciplines that are involved in tinnitus management, and reduce patients' prolonged suffering, non-adherence and endless referral trajectories.

Diagnostic accuracy and usability of the EMBalance decision support system for vestibular disorders in primary care: proof of concept randomised controlled study results.

BACKGROUND: Dizziness and imbalance are common symptoms that are often inadequately diagnosed or managed, due to a lack of dedicated specialists. Decision Support Systems (DSS) may support first-line physicians to diagnose and manage these patients based on personalised data. AIM: To examine the diagnostic accuracy and application of the EMBalance DSS for diagnosis and management of common vestibular disorders in primary care. METHODS: Patients with persistent dizziness were recruited from primary care in Germany, Greece, Belgium and the UK and randomised to primary care clinicians assessing the patients with (+ DSS) versus assessment without (- DSS) the EMBalance DSS. Subsequently, specialists in neuro-otology/audiovestibular medicine performed clinical evaluation of each patient in a blinded way to provide the "gold standard" against which the + DSS, - DSS and the DSS as a standalone tool (i.e. without the final decision made by the clinician) were validated. RESULTS: One hundred ninety-four participants (age range 25-85, mean = 57.7, SD = 16.7 years) were assigned to the + DSS (N = 100) and to the - DSS group (N = 94). The diagnosis suggested by the + DSS primary care physician agreed with the expert diagnosis in 54%, compared to 41.5% of cases in the - DSS group (odds ratio 1.35). Similar positive trends were observed for management and further referral in the + DSS vs. the - DSS group. The standalone DSS had better diagnostic and management accuracy than the + DSS group. CONCLUSION: There were trends for improved vestibular diagnosis and management when using the EMBalance DSS. The tool requires further development to improve its diagnostic accuracy, but holds promise for timely and effective diagnosis and management of dizzy patients in primary care. TRIAL REGISTRATION NUMBER: NCT02704819 (clinicaltrials.gov).

Audiological findings in professionals exposed to music and their relation with tinnitus.

Professional musicians are at high risk of developing tinnitus due to their over-exposure to music at both occupational and recreational level. This is a 5-year long prospective case series study performed in the Musicians/Performing Arts Medicine Clinic of the 1st Otorhinolaryngology Department of the National and Kapodistrian University of Athens. A total of 274 professional musicians underwent thorough medical history, history of music exposure, assessment of the impact their hearing status has on their professional life (Musicians Hearing Handicap Index), behavioral (Pure Tone Audiometry, standard and extended high frequency) and objective audiometric tests (TEOAE and DPOAE). Standard pure tone audiometry thresholds were correlated with the presence of tinnitus only at high frequencies. Musicians with tinnitus had a clinical and significant higher MHHI score and the incidence of tinnitus was significantly higher in participants suffering from musculoskeletal disease and those with abnormal PTA. Participants' hours of practice were similar in those with tinnitus and those without. The tinnitus group (and in order of descending effect size) had significantly worse thresholds in high frequency audiometry (≥3000Hz) as well as lower signal to noise ratios in DPOAE at almost all frequencies and in TEOAE at high frequencies (2.8 and 4kHz). A subgroup analysis of the musicians with normal PTA, showed that those with tinnitus showed elevated thresholds in the extended high frequency. In conclusion, tinnitus occurrence in musicians with normal audiogram is potentially correlated with high frequency hearing loss and impaired otoacoustic emissions and these two examinations should be considered in this group.

Systematic review of sound stimulation to elicit tinnitus residual inhibition.

BACKGROUND: Residual Inhibition is considered as tinnitus alteration immediately after exposure to sound. Its clinical significance and correlation with the pathophysiology and treatment prognosis of tinnitus remain enigmatic. The objective of this review is to critically appraise scientific evidence regarding the residual inhibition prevalence and how it is correlated with different sound stimuli. METHODS: A systematic review of tinnitus Residual Inhibition (RI) studies was performed, focusing on prevalence, methods used, stimuli presented and responses obtained. A literature search (PubMed, Cochrane Central Register of Controlled Trials, Scopus, MEDLINE) was conducted. Seventeen studies involving 1066 patients fulfilled the inclusion criteria. Sound stimulation was performed using pure tones, customized sounds, narrow- and broadband noises, and modulated sounds. RESULTS: Sound stimuli exposure produced complete RI of tinnitus in 34.5% of patients (range 5.6-72%), with higher RI rates after stimulation with pure tones and narrowband noise centered to the tinnitus perceived pitch. RI duration tends to increase when stimuli duration increases. CONCLUSIONS: RI is frequent and can be induced by narrow-band noise (NBN), broadband noise (BBN), pure tones, customized sounds and modulated sounds. Adequate evidence to support the use of RI as a tool for tinnitus phenotyping or as a management option is pending. Further clinical research exploring the profile of patients with RI and its potential use as prognostic factor should be conducted.

Systematic Review on Healthcare and Societal Costs of Tinnitus.

Tinnitus disability is a heterogeneous and complex condition, affecting more than 10% and compromising the quality of life of 2% of the population, with multiple contributors, often unknown, and enigmatic pathophysiology. The available treatment options are unsatisfactory, as they can, at best, reduce tinnitus severity, but not eliminate its perception. Given the spread of tinnitus and the lack of a standardized treatment, it is crucial to understand the economic burden of this condition. We conducted a systematic review of the literature on PubMed/MEDLINE, Embase, the Cochrane Database of Systematic Reviews (CDSR) and Google Scholar, in order to identify all the articles published on the economic burden of tinnitus before 1 April 2021 (PROSPERO-International prospective register of systematic reviews-No: CRD42020180438). Out of 273 articles identified through our search strategy, only five articles from studies conducted in the United States of America (USA), the Netherlands and the United Kingdom (UK) provided data on tinnitus's economic costs. Three studies provided mean annual estimates per patient ranging between EUR 1544 and EUR 3429 for healthcare costs, between EUR 69 and EUR 115 for patient and family costs and between EUR 2565 and EUR 3702 for indirect costs, including productivity loss. The other two studies reported an annual mean cost of EUR 564 per patient for tinnitus-related clinical visits, and total costs of EUR 1388 and EUR 3725 for patients treated with a sound generator and Neuromonics Tinnitus Treatment, respectively. Our comprehensive review shows a gap in the knowledge about the economic burden of tinnitus on healthcare systems, patients and society. The few available studies show considerable expenses due to healthcare and indirect costs, while out-of-pocket costs appear to be less financially burdensome. Comprehensive health economic evaluations are needed to fill the gaps in current knowledge, using a unified method with reliable and standardized tools.

EHealth and Its Role in Supporting Audiological Rehabilitation: Patient Perspectives on Barriers and Facilitators of Using a Personal Hearing Support System With Mobile Application as Part of the EVOTION Study.

BACKGROUND: Hearing loss is a major public health challenge. Audiology services need to utilise a range of rehabilitative services and maximise innovative practice afforded by technology to actively promote personalized, participatory, preventative and predictive care if they are to cope with the social and economic burden placed on the population by the rapidly rising prevalence of hearing loss. Digital interventions and teleaudiology could be a key part of providing high quality, cost-effective, patient-centred management. There is currently very limited evidence that assesses the hearing impaired patient perspective on the acceptance and usability of this type of technology. AIM: This study aims to identify patient perceptions of the use of a hearing support system including a mobile smartphone app when used with Bluetooth-connected hearing aids across the everyday life of users, as part of the EVOTION project. METHODS: We applied a questionnaire to 564 participants in three countries across Europe and analysed the following topics: connectivity, hearing aid controls, instructional videos, audiological tests and auditory training. KEY FINDINGS: Older users were just as satisfied as younger users when operating this type of technology. Technical problems such as Bluetooth connectivity need to be minimised as this issue is highly critical for user satisfaction, engagement and uptake. A system that promotes user-controllability of hearing aids that is more accessible and easier to use is highly valued. Participants are happy to utilise monitoring tests and auditory training on a mobile phone out of the clinic but in order to have value the test battery needs to be relevant and tailored to each user, easy to understand and use. Such functions can elicit a negative as well as positive experience for each user. CONCLUSION: Older and younger adults can utilise an eHealth mobile app to complement their rehabilitation and health care. If the technology works well, is tailored to the individual and in-depth personalised guidance and support is provided, it could assist maximisation of hearing aid uptake, promotion of self-management and improving outcomes.

Investigating the feasibility and acceptability of the HOLOBalance system compared with standard care in older adults at risk for falls: study protocol for an assessor blinded pilot randomised controlled study.

INTRODUCTION: Approximately one in three of all older adults fall each year, with wide ranging physical, psychosocial and healthcare-related consequences. Exercise-based interventions are the cornerstone for falls prevention programmes, yet these are not consistently provided, do not routinely address all components of the balance system and are often not well attended. The HOLOBalance system provides an evidence-based balance training programme delivered to patients in their home environment using a novel technological approach including an augmented reality virtual physiotherapist, exergames and a remote monitoring system. The aims of this proof-of-concept study are to (1) determine the safety, acceptability and feasibility of providing HOLOBalance to community dwelling older adults at risk for falls and (2) provide data to support sample size estimates for a future trial. METHODS: A single (assessor) blinded pilot randomised controlled proof of concept study. 120 participants will be randomised to receive an 8-week home exercise programme consisting of either: (1) HOLOBalance or (2) The OTAGO Home Exercise Programme. Participants will be required to complete their exercise programme independently under the supervision of a physiotherapist. Participants will have weekly telephone contact with their physiotherapist, and will receive home visits at weeks 0, 3 and 6. Outcome measures of safety, acceptability and feasibility, clinical measures of balance function, disability, balance confidence and cognitive function will be assessed before and immediately after the 8 week intervention. Acceptability and feasibility will be explored using descriptive statistics, and trends for effectiveness will be explored using general linear model analysis of variance. ETHICS AND DISSEMINATION: This study has received institutional ethical approvals in Germany (reference: 265/19), Greece (reference: 9769/24-6-2019) and the UK (reference: 19/LO/1908). Findings from this study will be submitted for peer-reviewed publications. TRIAL REGISTRATION NUMBER: NCT04053829. PROTOCOL VERSION: V.2, 20 January 2020.

Using Big Data to Develop a Clinical Decision Support System for Tinnitus Treatment.

Tinnitus is a common symptom of a phantom sound perception with a considerable socioeconomic impact. Tinnitus pathophysiology is enigmatic and its significant heterogeneity reflects a wide spectrum of clinical manifestations, severity and annoyance among tinnitus sufferers. Although several interventions have been suggested, currently there is no universally accepted treatment. Moreover, there is no well-established correlation between tinnitus features or patients' characteristics and projection of treatment response. At the clinical level, this practically means that selection of treatment is not based on expected outcomes for the particular patient.The complexity of tinnitus and lack of well-adapted prognostic factors for treatment selection highlight a potential role for a decision support system (DSS). A DSS is an informative system, based on big data that aims to facilitate decision-making based on: specific rules, retrospective data reflecting results, patient profiling and predictive models. Therefore, it can use algorithms evaluating numerous parameters and indicate the weight of their contribution to the final outcome. This means that DSS can provide additional information, exceeding the typical questions of superiority of one treatment versus another, commonly addressed in literature.The development of a DSS for tinnitus treatment selection will make use of an underlying database consisting of medical, epidemiological, audiological, electrophysiological, genetic and tinnitus subtyping data. Algorithms will be developed with the use of machine learning and data mining techniques. Based on the profile features identified as prognostic these algorithms will be able to suggest whether additional examinations are needed for a robust result as well as which treatment or combination of treatments is optimal for every patient in a personalized level.In this manuscript we carefully define the conceptual basis for a tinnitus treatment selection DSS. We describe the big data set and the knowledge base on which the DSS will be based and the algorithms that will be used for prognosis and treatment selection.

Tinnitus and tinnitus disorder: Theoretical and operational definitions (an international multidisciplinary proposal).

As for hypertension, chronic pain, epilepsy and other disorders with particular symptoms, a commonly accepted and unambiguous definition provides a common ground for researchers and clinicians to study and treat the problem. The WHO's ICD11 definition only mentions tinnitus as a nonspecific symptom of a hearing disorder, but not as a clinical entity in its own right, and the American Psychiatric Association's DSM-V doesn't mention tinnitus at all. Here we propose that the tinnitus without and with associated suffering should be differentiated by distinct terms: "Tinnitus" for the former and "Tinnitus Disorder" for the latter. The proposed definition then becomes "Tinnitus is the conscious awareness of a tonal or composite noise for which there is no identifiable corresponding external acoustic source, which becomes Tinnitus Disorder "when associated with emotional distress, cognitive dysfunction, and/or autonomic arousal, leading to behavioural changes and functional disability.". In other words "Tinnitus" describes the auditory or sensory component, whereas "Tinnitus Disorder" reflects the auditory component and the associated suffering. Whereas acute tinnitus may be a symptom secondary to a trauma or disease, chronic tinnitus may be considered a primary disorder in its own right. If adopted, this will advance the recognition of tinnitus disorder as a primary health condition in its own right. The capacity to measure the incidence, prevalence, and impact will help in identification of human, financial, and educational needs required to address acute tinnitus as a symptom but chronic tinnitus as a disorder.

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.

Tinnitus healthcare: a survey revealing extensive variation in opinion and practices across Europe.

Tinnitus remains a scientific and clinical problem whereby, in spite of increasing knowledge on effective treatment and management for tinnitus, very little impact on clinical practice has been observed. There is evidence that prolonged, obscure and indirect referral trajectories persist in usual tinnitus care. OBJECTIVE: It is widely acknowledged that efforts to change professional practice are more successful if barriers are identified and implementation activities are systematically tailored to the specific determinants of practice. The aim of this study was to administer a health service evaluation survey to scope current practice and knowledge of standards in tinnitus care across Europe. The purpose of this survey was to specifically inform the development process of a European clinical guideline that would be implementable in all European countries. DESIGN: A health service evaluation survey was carried out. SETTING: The survey was carried out online across Europe. PARTICIPANTS: Clinical experts, researchers and policy-makers involved in national tinnitus healthcare and decision-making. OUTCOME MEASURES: A survey was developed by the study steering group, piloted on clinicians from the TINNET network and underwent two iterations before being finalised. The survey was then administered to clinicians and policy-makers from 24 European countries. RESULTS: Data collected from 625 respondents revealed significant differences in national healthcare structures, use of tinnitus definitions, opinions on characteristics of patients with tinnitus, assessment procedures and particularly in available treatment options. Differences between northern and eastern European countries were most notable. CONCLUSIONS: Most European countries do not have national clinical guidelines for the management of tinnitus. Reflective of this, clinical practices in tinnitus healthcare vary dramatically across countries. This equates to inequities of care for people with tinnitus across Europe and an opportunity to introduce standards in the form of a European clinical guideline. This survey has highlighted important barriers and facilitators to the implementation of such a guideline.