Effectiveness of transcutaneous vagus nerve stimulation for the treatment of tinnitus: an interventional prospective controlled study.

OBJECTIVES: The aim of this interventional non-randomised prospective controlled study was to assess the effectiveness of transcutaneous vagus nerve stimulation (tVNS) in human subjects with tinnitus. DESIGN: The ParasymTM tVNS device was paired with an auditory stimulation. Treatment and observations were conducted over 12 weeks. Audiological evaluation was performed. Responses from a set of questionnaires and quantitative electroencephalography (qEEG) before and after treatment were collected. Voice measurements were done to assess possible side-effects of tVNS. STUDY SAMPLE: The study involved 29 adults who had chronic tinnitus (15 patients who underwent tVNS paired with sounds and a control group of 14 patients who did not). RESULTS: In general, subjective and objective measurements of tinnitus showed no improvement in the study group compared to the controls, although certain parameters as gauged by the questionnaires did statistically improve. The loudness and frequency of tinnitus remained the same in both groups. For the qEEG, activity in the theta band increased significantly in the study group compared to the control group. CONCLUSIONS: The tVNS was not effective in reducing tinnitus symptoms in our study group. However, changes in the theta band suggest there might be cortical effects that might, with sustained treatment, lead to improvements.

QoL, CIs, QALYs, and Individualized Rehabilitation: The Clinical and Practical Benefits of Regularly Assessing the Quality of Life of Adult Cochlear Implant Recipients.

This study aimed to report quality of life (QoL) scores in unilateral cochlear implant (CI) users and to generate guidance for clinicians on using QoL measures to individualize CI counselling and rehabilitation and to increase access to CIs as a mode of rehabilitation. Participants (n = 101) were unilateral CI users with single-sided deafness (SSD; n = 17), asymmetrical hearing loss (AHL; n = 26), or bilateral hearing loss (Uni; n = 58). Generic QoL was assessed via the Health Utilities Index (HUI-3), and disease-specific QoL was assessed via the Speech, Spatial, and Qualities of Hearing scale (SSQ12) and Nijmegen CI Questionnaire (NCIQ) at preimplantation and at 6 and 12 months of CI use. All groups had significantly increased HUI-3 scores at both intervals. The SSD group showed significant benefit on the SSQ12 at visit 3, the AHL group showed significant benefit on the SSQ12 and most NCIQ subdomains at both intervals, and the Uni group showed significant benefit with both tests at both intervals. Unilateral CI recipients demonstrate improved QoL within the first 12 months of device use. Regular assessment with generic and disease-specific questionnaires has the potential to play an important role in personalizing treatment and possibly in increasing access to CI provision.

Hyperacusis Assessment Questionnaire-A New Tool Assessing Hyperacusis in Subjects with Tinnitus.

Hyperacusis, a kind of decreased sound tolerance, is difficult to measure objectively. It often co-occurs with tinnitus. There is a need for valid and reliable patient-reported outcome measures to capture this subjective phenomenon. The aim of the study was to create a questionnaire capturing hyperacusis in terms of loudness, fear, and pain and to evaluate its psychometric properties. The study sample consisted of 106 adult patients with hyperacusis and tinnitus with a mean age of 45.2 years. A medical interview, an audiological examination, and several questionnaires (the Tinnitus Handicap Inventory, the Hyperacusis Questionnaire, the State-Trait Anxiety Inventory, and Visual Analog Scales) were applied. The final 14-item Hyperacusis Assessment Questionnaire showed an appropriate three-factor structure with 70.5% of the variance explained. Convergent and divergent validity were confirmed by correlations with other measures of hyperacusis, anxiety, tinnitus severity, misophonia, and hearing thresholds. The internal consistency assessed with Cronbach's alpha was excellent (α = 0.91), as was reproducibility (intraclass correlation, ICC = 0.96). The new Hyperacusis Assessment Questionnaire is a psychometrically sound and brief tool assessing the severity of hyperacusis in terms of loudness, fear, and pain. It can be used in clinical practice and scientific research for patients with hyperacusis and tinnitus.

Chronic Tinnitus and the Positive Effects of Sound Treatment via a Smartphone App: Mixed-Design Study.

BACKGROUND: Tinnitus is a phantom auditory sensation in the absence of an external stimulus. It is accompanied by a broad range of negative emotional symptoms and a significantly lower quality of life. So far, there is no cure for tinnitus, although various treatment options have been tried. One of them is mobile technology employing dedicated apps based on sound therapy. The apps can be managed by the patient and tailored according to their needs. OBJECTIVE: The study aims to assess the effect of a mobile app that generates background sounds on the severity of tinnitus. METHODS: The study involved 68 adults who had chronic tinnitus. Participants were divided into a study group (44 patients) and a control group (24 patients). For 6 months those in the study group used a free mobile app that enriched the sound environment with a background sound. Participants were instructed to use the app for at least 30 minutes a day using their preferred sound. The participants in the control group did not use the app. Subjective changes in the day-to-day functioning of both groups were evaluated using the Tinnitus Handicap Inventory (THI) questionnaire, a visual analog scale, and a user survey. RESULTS: After 3 months of using the app, the THI global score significantly decreased (P<.001) in the study group, decreasing again at 6 months (P<.001). The largest improvements were observed in the emotional and catastrophic reactions subscales. A clinically important change in the THI was reported by 39% of the study group (17/44). Almost 90% of the study participants (39/44) chose environmental sounds to listen to, the most popular being rain and ocean waves. In the control group, tinnitus severity did not change over 3 or 6 months. CONCLUSIONS: Although the participants still experienced limitations caused by tinnitus, the advantage of the app was that it led to lower negative emotions and thus reduced overall tinnitus severity. It is worth considering whether a mobile app might be incorporated into the management of tinnitus in a professional setting.

Using Generic and Disease-Specific Measures to Assess Quality of Life before and after 12 Months of Hearing Implant Use: A Prospective, Longitudinal, Multicenter, Observational Clinical Study.

The primary objectives of this study were to evaluate the effect of hearing implant (HI) use on quality of life (QoL) and to determine which QoL measure(s) quantify QoL with greater sensitivity in users of different types of HIs. Participants were adult cochlear implant (CI), active middle ear implant (VIBRANT SOUNDBRIDGE (VSB)), or active transcutaneous bone conduction implant (the BONEBRIDGE (BB)) recipients. Generic QoL and disease-specific QoL were assessed at three intervals: pre-activation, 6 months of device use, and 12 months of device use. 169 participants completed the study (110 CI, 18VSB, and 41BB). CI users' QoL significantly increased from 0-6 m device use on both the generic- and the disease-specific measures. On some device-specific measures, their QoL also significantly increased between 6 and 12 m device use. VSB users' QoL significantly increased between all tested intervals with the disease-specific measure but not the generic measure. BB users' QoL significantly increased from 0-6 m device use on both the generic- and the disease-specific measures. In sum, HI users experienced significant postoperative increases in QoL within their first 12 m of device use, especially when disease-specific measures were used. Disease-specific QoL measures appeared to be more sensitive than their generic counterparts.

Effectiveness of tinnitus therapy using a mobile application.

BACKGROUND: The World Health Organization reports that the number of tinnitus sufferers is increasing year on year. Given the common use of mobile devices and the availability of applications designed to support patients in tinnitus therapy and reduce tinnitus severity, patients seeking help are likely to try this form of support. The aim of this study was to evaluate the effectiveness of a mobile application in tinnitus sound therapy, in this case ReSound Tinnitus Relief™. METHODS: The study involved 52 patients hospitalized for tinnitus. All participants used the free ReSound Tinnitus Relief application for 6 months. The application is based on sound therapy. Patients were advised to use the application for at least 30 min per day, the sounds should not completely mask the tinnitus, and they should be listened to via a loudspeaker. The effects of the therapy were evaluated by means of standardized questionnaires for tinnitus severity: the Tinnitus Handicap Inventory and the Tinnitus Functional Index. RESULTS: The study showed a reduction in tinnitus severity as measured by both questionnaires. The general severity decreased after the first 3 months and again in the following 3 months of using the application. In both questionnaires the biggest changes were observed in the subscales of emotions. CONCLUSIONS: Results obtained here from standardized questionnaires indicate that the tested application may contribute to tinnitus reduction. However, it is advisable to conduct further research on the applicability of such technology in medical practice.

Self-help interventions chosen by subjects with chronic tinnitus - a retrospective study of clinical patients.

OBJECTIVE: Self-help (without specialist support) can play an important role in tinnitus therapy. The purpose of this study was to investigate what fraction of subjects with tinnitus use self-help, what techniques are most commonly used to reduce tinnitus severity, and what distinguishes patients that use self-help from others. DESIGN: retrospective, observational study. STUDY SAMPLE: Adult patients admitted to our hospital clinic (460 participants) aged 19-83 years and reporting chronic tinnitus. The survey concerned therapy attempts prior to the clinic visit as well as self-help techniques chosen freely by the patient to reduce tinnitus severity. RESULTS: Data showed that 40.9% of the respondents chose some action themselves to reduce their tinnitus severity. Among the reported self-help techniques, acoustic stimulation was the most popular. In addition, patients chose distraction attention, relaxation, meditation, yoga, and physical activity. The likelihood of undertaking self-help increases with better education and higher tinnitus severity. CONCLUSIONS: Knowledge about patients' preferences of forms of self-help may help the health practitioner suggest a more suitable form of therapy. Due to the great interest in using sound therapy in tinnitus, it would be worthwhile looking at new forms of this therapy, for example increasingly popular mobile applications.

Auditory processing in normally hearing individuals with and without tinnitus: assessment with four psychoacoustic tests.

PURPOSE: In most cases, tinnitus co-exists with hearing loss, suggesting that poorer speech understanding is simply due to a lack of acoustic information reaching the central nervous system (CNS). However, it also happens that patients with tinnitus who have normal hearing also report problems with speech understanding, and it is possible to suppose that tinnitus is to blame for difficulties in perceptual processing of auditory information. The purpose of the study was to evaluate the auditory processing abilities of normally hearing subjects with and without tinnitus. METHODS: The study group comprised 97 adults, 54 of whom had normal hearing and chronic tinnitus (the study group) and 43 who had normal hearing and no tinnitus (the control group). The audiological assessment comprised pure-tone audiometry and high-frequency pure-tone audiometry, impedance audiometry, and distortion product oto-acoustic emission assessment. To evaluate possible auditory processing deficits, the Frequency Pattern Test (FPT), Duration Pattern Test (DPT), Dichotic Listening Test (DLT), and Gap Detection Threshold (GDT) tests were performed. RESULTS: The tinnitus subjects had significantly lower scores than the controls in the gap detection test (p < 0.01) and in the dichotic listening test (p < 0.001), but only for the right ear. The results for both groups were similar in the temporal ordering tests (FPT and DPT). Right-ear advantage (REA) was found for the controls, but not for the tinnitus subjects. CONCLUSION: In normally hearing patients, the presence of tinnitus may be accompanied with auditory processing difficulties.

Job satisfaction in a group of patients with tinnitus.

BACKGROUND: Tinnitus is an auditory impression without any external auditory stimulus. It may cause negative symptoms (anxiety, insomnia, depression) significantly affecting work performance and job satisfaction. OBJECTIVE: To evaluate the job satisfaction in tinnitus sufferers. METHODS: Cross-sectional study were conducted and 51 individuals (23-70 years) were recruited. Participants completed two questionnaires: Tinnitus Handicap Inventory and Job Satisfaction Scale. RESULTS: People affected by tinnitus report higher job satisfaction than healthy people. Job satisfaction was significantly related to age: r = 0.31; p < 0.05 in all tinnitus patients. There was a correlation between job satisfaction and tinnitus severity but only in people with normal hearing (-0.69; p < 0.05). CONCLUSIONS: The results show that job satisfaction is affected by the level of tinnitus annoyance (from both its emotional and functional aspects), but only in people with normal hearing. In future research it is recommended that additional factors be investigated, both work and non-work related, to thoroughly explore the impact of tinnitus on job satisfaction.

Decreased Sound Tolerance in Tinnitus Patients.

(1) Background: Decreased sound tolerance is a significant problem in tinnitus sufferers. The aim of the study was to evaluate the relationship between tinnitus and decreased sound tolerance (hyperacusis and misophonia). (2) Methods: The study sample consisted of 74 patients with tinnitus and decreased sound tolerance. The procedure comprised patient interviews, pure tone audiometry, impedance audiometry, measurement of uncomfortable loudness levels, and administration of the Hyperacusis Questionnaire, Tinnitus Handicap Inventory, and Visual Analogue Scales. (3) Results: The majority (69%) of the patients reported that noise aggravated their tinnitus. The correlation between tinnitus and hyperacusis was found to be statistically significant and positive: r = 0.44; p < 0.01. The higher the tinnitus severity, the greater the hyperacusis. There was no correlation between misophonia and hyperacusis (r = 0.18; p > 0.05), or between misophonia and tinnitus (r = 0.06; p > 0.05). (4) Conclusions: For tinnitus patients the more significant problem was hyperacusis rather than misophonia. The diagnosis and treatment of decreased sound tolerance should take into account not only audiological, but also psychological problems of the patients.

How to Interpret Tinnitus Functional Index Scores: A Proposal for a Grading System Based on a Large Sample of Tinnitus Patients.

OBJECTIVES: The Tinnitus Functional Index (TFI) is considered the gold standard in measuring tinnitus severity. The aim of the study was to establish reference values to improve the interpretability of TFI scores. DESIGN: Results from 1114 patients with tinnitus were retrospectively analyzed. The participants were consecutive patients who attended our tertiary referral Ear, Nose, and Throat Center. The eligibility criteria were: at least 18 years old, persistent tinnitus, completed pure-tone audiometry, and answered all 25 items on the TFI. Hearing status (normal hearing vs. hearing impairment) was established according to the recommendation of the Bureau International d'Audiophonologie. Means (M) and SD on the TFI were the basis for grading tinnitus severity on four levels: low, lower moderate, upper moderate, and high. To gauge individual scores in clinical practice, percentiles are also proposed. RESULTS: All 1114 patients (586 women and 528 men) were Caucasian and aged from 19 to 87 years (M = 50.96; SD = 13.10 years). Tinnitus duration ranged from 0.5 to 50 years (M = 7.17; SD = 7.71 years). There were 258 patients with normal hearing and 856 patients with hearing loss. A score of above 65 points on TFI was established as the cutoff point for diagnosing high tinnitus severity. A regression model associating tinnitus severity with gender, age, tinnitus duration, and hearing loss was statistically significant: F(4,1109) = 8.99; p < 0.001, but the effect was very small (R2adj = 0.028) and only gender and age were associated with TFI global score, while tinnitus severity was not related to tinnitus duration or hearing loss. CONCLUSIONS: The reference values proposed here support those reported previously by Meikle et al. They are empirically based and can be used as benchmarks in clinical practice and scientific research. They make it possible to assess tinnitus severity, evaluate individual scores, and categorize individuals with tinnitus. This allows researchers to set inclusion or exclusion criteria when assigning patients to specific groups during clinical trials involving tinnitus intervention strategies.

A revised grading system for the Tinnitus Handicap Inventory based on a large clinical population.

Objective: Tinnitus Handicap Inventory (THI) is one of the world's most commonly used tools to assess tinnitus severity. The aim of the current study was to establish a revised THI grading system using standard Z-scores and percentiles.Design: Cross-sectional observational study.Study sample: Adult patients (1042 participants - 518 (49.7%) female and 524 (50.3%) male) reporting tinnitus duration of a minimum of 6 months with complete documentation on patient's clinical status (age, gender, tinnitus duration and laterality, tinnitus handicap based on THI and hearing status based on pure-tone audiometry) were included in the study.Results: Multivariate analysis of variance was used to analyse the effects of gender and hearing loss on THI scores and revealed there was a significant effect of both. Consequently, separate grading systems for women and men, as well as for subjects with normal hearing and hearing loss, is proposed.Conclusions: Our findings are generally consistent with existing grading. Normative values proposed for THI scores, based on a large group of tinnitus patients, could be useful to guide decisions about appropriate intervention options or to evaluate treatment outcomes.