Various stimulation-based rehabilitation approaches have been proposed to alleviate tinnitus. This study aimed to determine the efficacy of a rehabilitation approach that simultaneously provides microcurrent and sound stimulation for tinnitus relief. Twenty-eight participants with chronic sensorineural tinnitus were randomly assigned to one of two groups based on the rehabilitation approaches (sound therapy-only group and combined microcurrent and sound therapy group). Each participant underwent sound therapy or simultaneous stimulation for approximately 2 h daily for 3 months. The effectiveness of the rehabilitation approaches was determined based on changes in the Korean version of the tinnitus primary function questionnaire (K-TPFQ) and visual analog scale for loudness (VAS-L) scores at baseline, 1.5 months, and 3 months. For the K-TPFQ scores, both groups exhibited a large effect of rehabilitation; however, for the VAS-L scores, the simultaneous stimulation group demonstrated a large effect of rehabilitation, whereas the sound therapy group exhibited a small effect. Therefore, a rehabilitation approach that combines sound stimulation with microcurrent stimulation can improve response and perception in tinnitus.

Tinnitus acoustic therapy is defined as any use of sound where the intent is to alter the tinnitus perception and/or the reactions to tinnitus in a clinically beneficial way. The parameters of sound that may cause beneficial effects, however, are currently only theorized with limited data supporting their effectiveness. Residual inhibition is the temporary suppression or elimination of tinnitus that is usually observed following appropriate auditory stimulation. Our pilot study investigated the effects of a therapeutic acoustic stimulus that was individually customized to maximize residual inhibition of tinnitus and extend its duration to determine if there could be a sustained suppression of the tinnitus signal (i.e., reduced tinnitus loudness) and a reduction in the psychological and emotional reactions to tinnitus. This pilot study had two objectives: (1) to evaluate the feasibility of residual inhibition technique therapy through daily use of hearing aids and (2) to determine its effects by measuring reactionary changes in tinnitus with the Tinnitus Functional Index (TFI) and perceptual changes in tinnitus loudness. A total of 20 adults (14 males, 6 females; mean age: 58 years, SD = 12.88) with chronic tinnitus were enrolled in a four-visit study that consisted of the following: (1) baseline visit and initiation of the intervention period, (2) a 1-month postintervention visit, (3) 2-month postintervention visit and initiation of a wash-out period, and (4) a 3-month visit to assess the wash-out period and any lasting effects of the intervention. The intervention consisted of fitting bilateral hearing aids and creating an individualized residual inhibition stimulus that was streamed via Bluetooth from a smartphone application to the hearing aids. The participants were instructed to wear the hearing aids and stream the residual inhibition stimulus all waking hours for the 2-month intervention period. During the wash-out period, the participants were instructed to use the hearing aids for amplification, but the residual inhibition stimulus was discontinued. At all visits, the participants completed the TFI, study-specific self-report measures to document perceptions of tinnitus, a psychoacoustic test battery consisting of tinnitus loudness and pitch matching, and a residual inhibition test battery consisting of minimum masking and minimum residual inhibition levels. At the end of the trial, participants were interviewed about the study experience and acceptability of the residual inhibition treatment technique. Repeated measures analyses of variance (ANOVA) were conducted on the two main outcomes (TFI total score and tinnitus loudness) across all four visits. The results showed a significant main effect of visit on the TFI total score ( p  < 0.0001). Specifically, the results indicated a significant reduction in TFI total scores from baseline to the 1-month post-intervention period, which remained stable across the 2-month post-intervention period and the wash-out period. The ANOVA results did not show a significant change in tinnitus loudness as a function of visit ( p  = 0.480). The majority of the participants reported a positive experience with the study intervention at their exit interview. This pilot study demonstrated that residual inhibition as a sound therapy for tinnitus, specifically through the daily use of hearing aids, was feasible and acceptable to individuals suffering from chronic tinnitus. In addition, participants showed improvement in reactions to tinnitus as demonstrated by sustained reduction in TFI scores on average over the course of the treatment period. Achieving residual inhibition may also provide patients a feeling of control over their tinnitus, and this may have a synergistic effect in reducing the psychological and emotional distress associated with tinnitus. There was no significant reduction in long-term tinnitus loudness resulting from the residual inhibition treatment; however, the current pilot study may not have had sufficient power to detect such a change. The combination of tinnitus suppression and improved psychosocial/emotional reactions to tinnitus may result in a better quality of life in both the short and long term. A larger-scale study is needed to determine the validity of using residual inhibition as a clinical therapy option and to ascertain any effects on both perception and reactions to tinnitus.

Tinnitus retraining therapy (TRT) is a standard treatment for tinnitus that consists of directive counseling and sound therapy. However, it is based on face-to-face education and a time-consuming protocol. Smart device-based TRT (smart-TRT) seems to have many advantages, but the efficacy of this new treatment has been questioned.
The aim of this study was to compare the efficacy between smart-TRT and conventional TRT (conv-TRT).
We recruited 84 patients with tinnitus. Results were compared between 42 patients who received smart-TRT and 42 control participants who received conv-TRT. An interactive smart pad application was used for directive counseling in the smart-TRT group. The smart pad application included detailed education on ear anatomy, the neurophysiological model of tinnitus, concept of habituation, and sound therapy. The smart-TRT was bidirectional: There were 17 multiple choice questions between each lesson as an interim check. The conv-TRT group underwent traditional person-to-person counseling. The primary outcome measure was the Tinnitus Handicap Inventory (THI), and the secondary outcome measure was assessed using a visual analogue scale (VAS).
Both treatments had a significant treatment effect, which comparably improved during the first 2 months. The best improvements in THI were -23.3 (95% CI -33.1 to -13.4) points at 3 months and -16.8 (95% CI -30.8 to -2.8) points at 2 months in the smart-TRT group and conv-TRT group, respectively. The improvements on the VAS were also comparable: smart-TRT group: -1.2 to -3.3; conv-TRT: -0.7 to -1.7.
TRT based on smart devices can be an effective alternative for tinnitus patients. Considering the amount of time needed for person-to-person counseling, smart-TRT can be a cost-effective solution with similar treatment outcomes as conv-TRT.

This study investigated the effect of sound therapy combined with drug therapy (SDT) on gap detection threshold and speech recognition scores in patients with sudden sensorineural hearing loss (SSNHL).
Patients with SSNHL were grouped randomly into SDT and drug therapy (DT) groups. All patients received standard drug treatment and patients in the SDT group additionally received sound stimulation for the affected ears for 6 days. Pure tone audiogram, speech recognition scores at normal and time-compressed rates under quiet and noisy conditions, and the gap detection threshold of the SDT and DT groups before treatment and on day 6 and 30 after treatment were compared.
There were 20 patients in the SDT group and 24 in the DT group. The pure tone thresholds of affected ears were significantly lower in the SDT group on day 6 after treatment than those in the DT group at 125 and 250 Hz. Significantly lower gap detection thresholds and higher speech recognition scores under noisy conditions were observed at the normal and time-compressed rates in the SDT group than those in the DT group on day 6 and 30 after treatment. Significant correlations were observed between the gap thresholds and speech recognition scores in a noisy environment at normal and time-compressed rates on day 6 and 30.
SDT may improve the recovery of hearing abilities, such as the gap in noise thresholds and speech recognition in noise, in the case of SSNHL.
ChiCTR-IOR-17012262.

UNASSIGNED: This randomized single-blind controlled trial tested the hypothesis that a prototype digital therapeutic developed to provide goal-based counseling with personalized passive and active game-based sound therapy would provide superior tinnitus outcomes, and similar usability, to a popular passive sound therapy app over a 12 week trial period.
UNASSIGNED: The digital therapeutic consisted of an app for iPhone or Android smartphone, Bluetooth bone conduction headphones, neck pillow speaker, and a cloud-based clinician dashboard to enable messaging and app personalization. The control app was a popular self-help passive sound therapy app called White Noise Lite (WN). The primary outcome measure was clinically meaningful change in Tinnitus Functional Index (TFI) between baseline and 12 weeks of therapy. Secondary tinnitus measures were the TFI total score and subscales across sessions, rating scales and the Client Oriented Scale of Improvement in Tinnitus (COSIT). Usability of the US and WN interventions were assessed using the System Usability Scale (SUS) and the mHealth App Usability Questionnaire (MAUQ). Ninety-eight participants who were smartphone app users and had chronic moderate-severe tinnitus (>6 months, TFI score > 40) were enrolled and were randomly allocated to one of the intervention groups. Thirty-one participants in the USL group and 30 in the WN group completed 12 weeks of trial.
UNASSIGNED: Mean changes in TFI for the USL group at 6 (16.36, SD 17.96) and 12 weeks (17.83 points, SD 19.87) were clinically meaningful (>13 points reduction), the mean change in WN scores were not clinically meaningful (6 weeks 10.77, SD 18.53; 12 weeks 10.12 points, SD 21.36). A statistically higher proportion of USL participants achieved meaningful TFI change at 6 weeks (55%) and 12 weeks (65%) than the WN group at 6 weeks (33%) and 12 weeks (43%). Mean TFI, rating and COSIT scores favored the US group but were not statistically different from WN. Usability measures were similar for both groups.
UNASSIGNED: The USL group demonstrated a higher proportion of responders than the WN group. The usability of the USL therapeutic was similar to the established WN app. The digital polytherapeutic demonstrated significant benefit for tinnitus reduction supporting further development.

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.
The study aims to assess the effect of a mobile app that generates background sounds on the severity of tinnitus.
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.
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.
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.

Tinnitus is often triggered by cochlear damage and has been linked with aberrant patterns of neuronal activity. Acoustic Coordinated Reset (CR®) Neuromodulation is a sound therapy hypothesised to reduce tinnitus symptoms by desynchronising pathological brain activity using a portable acoustic device (the T30 neurostimulator). We report results of a pivotal trial to test the efficacy of this intervention. This two-centre, double-blind randomised controlled trial with long-term open-label extension, was undertaken between February 2012 and February 2014 in the UK. Participants were 100 adults with tinnitus as a primary complaint, recruited through hearing clinics and media advertisements. Intervention was the device programmed either with the proprietary sound sequence or placebo algorithm, fit by one of five trained audiologists. Minimisation software provided group allocation (1:1 randomisation), with groups matched for age, gender, hearing loss and tinnitus severity. Allocation was masked from participants and assessors during the trial. The primary measure of efficacy was change in tinnitus symptom severity between groups, measured using the Tinnitus Handicap Questionnaire at 12 weeks. Secondary outcomes were other measures of tinnitus symptom severity, health-related quality of life, and perceptual characteristics (pitch, loudness, bandwidth) at 12 weeks, and Tinnitus Handicap Questionnaire at 36 weeks (open-label extension). A statistician blinded to the allocation conducted an intention-to-treat analysis that employed linear regressions on minimisation variables, trial centre and intervention group, with multiple imputations for missing data. The study was registered on clinicaltrials.gov (NCT01541969). We screened 391 individuals and assigned interventions to 100 eligible participants. The primary outcome was not statistically significant between groups (mean group = -0.45, 95% CI -5.25 to 4.35; p = 0.85), nor were any of the secondary outcomes. Four adverse events occurred during the trial. Analysis of tinnitus symptom severity data collected across the 24-week open-label extension showed no statistically significant within-group changes after 12, 24, or 36 weeks treatment with the proprietary sound sequence. While individual participants may benefit from sound therapy, Acoustic CR® Neuromodulation did not lead to group-mean reductions on tinnitus symptom severity or other measures compared to placebo, or over time.

This study aimed to investigate abnormal tinnitus activity by evaluating brain surface-based amplitude of low-frequency fluctuation (ALFF) changes detected by resting-state functional magnetic resonance imaging (RS-fMRI) in patients with idiopathic tinnitus before and after 24 weeks of sound therapy. We hypothesized that sound therapy could gradually return cortical local brain function to a relatively normal range. In this prospective observational study, we recruited thirty-three tinnitus patients who had undergone 24 weeks of sound therapy and 26 matched healthy controls (HCs). For the two groups of subjects, we analyzed the spontaneous neural activity of tinnitus patients by cortical ALFF and detected its correlation with clinical indicators of tinnitus. Patients\' Tinnitus Handicap Inventory (THI) scores were assessed to determine the severity of their tinnitus before and after treatment. Two-way mixed model analysis of variance and Pearson\'s correlation analysis were used in the statistical analysis. Student-Newman-Keuls tests were used in the post hoc analysis. Interaction effects between the two groups and between the two scans revealing local neural activity as assessed by ALFF were observed in the bilateral dorsal stream visual cortex (DSVC), bilateral posterior cingulate cortex (PCC), bilateral anterior cingulate and medial prefrontal cortex (ACC and MPC), left temporo-parieto-occipital junction (TPOJ), left orbital and polar frontal cortex (OPFC), left paracentral lobular and mid cingulate cortex (PCL and MCC), right insular and frontal opercular cortex (IFOC), and left early visual cortex (EVC). Importantly, local functional activity in the left TPOJ and right PCC in the patient group was significantly lower than that in the HCs at baseline and was increased to relatively normal levels after treatment. The 24-week sound therapy tinnitus group demonstrated significantly higher ALFF in the left TPOJ and right PCC than in the tinnitus baseline group. Also, compared with the HC baseline group and the 24-week HC group, the 24-week sound therapy tinnitus group demonstrated slightly lower or higher ALFF in the left TPOJ and right PCC, and there were no differences between the 24-week sound therapy tinnitus and HC groups. Decreased THI scores and ALFF changes in the abovementioned brain regions were not correlated. Taken together, surface-based RS-fMRI can provide more subtle local functional activity to explain the mechanism of tinnitus treatment, and long-term sound therapy had a normalizing effect on tinnitus patients.

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).
UNASSIGNED: 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.
CONCLUSIONS: 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.
BACKGROUND: ClinicalTrials.gov NCT04663828 . Registered on 11 December 2020.

UNASSIGNED: Sound therapy (ST) and stress reduction regimens have been successfully used to manage tinnitus. Virtual reality (VR) has been used to manage chronic conditions like intractable pain. The aim of the present study was to investigate whether the use of VR in conjunction with ST revealed additional improvements in tinnitus attributes as compared to ST alone.
UNASSIGNED: This study was a randomised controlled trial (RCT) with a cross-over design. All participants received two interventions - ST alone (control) and ST with VR stimuli (experimental). ST consisted of fractal tones while VR stimuli comprised of nature videos presented via VR goggles. A multilevel mixed-effects linear regression model was used to estimate the intervention effect.
UNASSIGNED: Twenty adults with subjective, continuous, chronic tinnitus participated in the study.
UNASSIGNED: After adjusting for period and baseline tinnitus loudness, significant improvements were observed in tinnitus loudness and Tinnitus Functional Index scores. Although not statistically significant, mean minimum masking levels were lower after the experimental intervention.
UNASSIGNED: Study participants benefitted from the use of VR in conjunction with ST in a laboratory setting. Additional effectiveness trials and blinded RCTs will be needed before validating the use of VR for tinnitus management in clinical settings.