A variety of non-pharmacologic treatments are being evaluated to improve the symptoms of tinnitus. Tinnitus describes the perception of any sound in the ear in the absence of an external stimulus and is a malfunction in the processing of auditory signals. In the majority of cases, tinnitus is subjective, in that it can be heard only by the patient, and is frequently self-limited. A hearing impairment, often noise-induced or related to aging, may be associated with tinnitus.
Most patients habituate to tinnitus; however, others may seek medical care if the tinnitus becomes too disruptive. Treatment has focused on counseling or use of tinnitus maskers that produce a broad band of continuous external noise that diverts attention or masks the tinnitus. Transcutaneous electrical stimulation to the external ear, transmeatal low-power laser irradiation, electromagnetic energy, transcranial direct current stimulation, and transcranial magnetic stimulation have also been proposed for the treatment of tinnitus.
Tinnitus retraining focuses counseling and behavioral retraining on the associations induced by tinnitus perception. The goal is not to eliminate the tinnitus itself, but to retrain the subcortical and cortical centers involved in processing the tinnitus signals. As part of the overall therapy, maskers are used to induce habituation to the tinnitus. In contrast to the typical use of maskers, in retraining therapy, the masker is not intended to drown out or mask the tinnitus, but is set at a level such that the tinnitus can still be detected. This strategy is thought to enhance habituation by increasing the neuronal activity within the auditory system such that the tinnitus is difficult to detect.
NOTE: This policy does not address pharmacologic treatment of tinnitus (e.g., the use of neurotoxins, amitriptyline or other tricyclic antidepressants).
Treatment of tinnitus with any of the following is considered EXPERIMENTAL/INVESTIGATIVE due to the lack of clinical evidence demonstrating an impact on improved health outcomes:
No additional statements.
Summary of Evidence
For individuals who have persistent, bothersome tinnitus who receive psychological coping therapy, the evidence includes randomized controlled trials (RCTs) and meta-analyses of RCTs. For individuals who have tinnitus who receive sound therapy, the evidence includes RCTs and a systematic review of RCTs. For individuals who have tinnitus who receive transcranial magnetic stimulation, the evidence includes a number of small- to moderate-sized RCTs and systematic reviews. For individuals who have tinnitus who receive transmeatal laser irradiation, the evidence includes RCTs and crossover trials. For individuals with tinnitus who receive transcranial direct current stimulation, the evidence consists of systematic reviews and a randomized controlled trial. Multiple studies have found the modalities have no benefit, while a few found some benefit for tinnitus, it has been noted across studies that further study would be needed to evaluate these treatment modality options. The evidence is insufficient to determine the improvement in health outcomes.
Rationale
A 2018 Cochrane review evaluated the evidence for masking in the management of tinnitus in adults. Eight RCTs (N=590 participants) were included that used noise-generating devices and/or hearing aids as the sole management tool or in combination with other strategies, including counseling. Seven studies looked at hearing aids, 3 evaluated sound generators, and 4 evaluated combination devices. The quality of the evidence was low. The risk of bias was unclear and there was little blinding. No studies were identified that compared masking devices with a wait-list or other control group. Reviewers concluded that it was uncertain whether a masking device (hearing aid, sound generator, or combination) would result in any difference in tinnitus symptom severity.
Scherer et al (2019) compared the effect of tinnitus retraining therapy (full and partial) versus standard of care on tinnitus-related quality of life in the randomized, placebo-controlled, multicenter, Tinnitus Retraining Therapy Trial (TRTT). The primary outcome of the TRTT study was the mean change in TQ score from baseline to follow-up, assessed at 3, 6, 12, and 18 months. There were a variety of secondary outcomes including scores on the TFI and THI. The mean patient age was 50.6 years, 29% were women, and 23.8% reported belonging to a minority group including 11.3% of Hispanic or Latino origin. Overall, longitudinal analyses revealed no difference between partial or full tinnitus retraining therapy compared with standard of care, or partial versus full tinnitus retraining therapy on TQ, TFI, or THI total scores. About 50% of all patients in the TRTT study showed clinically meaningful reductions in the effect of tinnitus on their daily lives. The TRTT study was limited by a larger than expected number of missed visits and withdrawals (mainly in the full and partial tinnitus retraining therapy groups) and lack of study clinician expertise in providing tinnitus retraining therapy at the time of study onset.
Soleimani et al (2016) published a systematic review of 15 double-blind, randomized trials with sham controls on rTMS. Seven of these trials were included in a meta-analysis. The primary outcomes were the mean THI and TQ scores. The secondary outcomes of therapeutic success were defined as a reduction of 7 points on the THI (maximum, 100) or 5 points on the TQ (maximum, 84), but the percentage of patients who achieved therapeutic success was not reported. The mean difference in TQ scores at 1 week after treatment was 3.42 (4 studies). The mean difference in THI scores between the TMS and sham groups was 6.71 at 1 month after treatment (4 studies ; p<.001) and 12.89 at 6 months after treatment (3 studies ; p<.001). A qualitative review of the 15 trials found significant benefit of rTMS in 9 and no significant effect in 6. Evidence on rTMS for tinnitus includes a number of small to moderate-sized randomized, sham-controlled trials and systematic reviews. Results from the trials are mixed, with some not finding a statistically significant effect of rTMS on tinnitus severity. Larger controlled trials for this common condition and longer follow-up are needed.
Song, et al (2012) published a systematic review of transcranial direct current stimulation (tDCS) for the treatment of tinnitus. Six studies (3 sham-controlled randomized trials, 3 uncontrolled, open-label studies) were selected for the review. Overall, there was a 39.5% response rate (criteria for responder was not defined), with a mean reduction of tinnitus intensity of 13.5%. Meta-analysis of 2 RCTs showed a medium-to-large effect sizes (ES) of 0.77. Investigators concluded that the efficacy of tDCS cannot be fully confirmed because of the limited number of studies, but tDCS may be a promising tool for tinnitus management.
Pal, et al (2015) reported on a trial involving 42 patients randomized to 5 days of sham stimulation or tDCS over the frontal and auditory cortices. They found no beneficial effect of tDCS on the primary (THI score) or secondary outcome measures in this adequately powered double-blind study.
A systematic review by Wang et al (2017) examined the impact of tDCS on patients with tinnitus. Outcomes assessed included: loudness (as observed by a change in magnitude), distress as experienced by those with tinnitus, and THI scores. The results were the following: there was no observable benefit to tDCS in reducing hearing loudness (pooled standardized difference in means, 0.671; 95 CI, -0.089 to 1.437; p=0.83); and tinnitus-related distress decreased for those using tDCS (pooled standardized difference in means, 0.634; 95% CI, 0.021 to 1.247; p=.043). Only 3 studies dealt with changes in THI scores. This systematic review reported a reduction in tinnitus-related distress, further study is needed to evaluate tDCS as a treatment option for tinnitus.
Jacquemin, et al (2018) published the results of a cohort study consisting of both a retrospective and prospective aspect, aiming to compare 2 transcranial direct current stimulation (tDCS) electrode placements and to explore effects of high-definition (HD) tDCS by matched-pairs analyses. The total population (n=78) was split into two groups of 39 participants each. One group (n=39) received tDCS of the dorsolateral prefrontal cortex (DLPFC) and the other (n=39) received tDCS of the right supraorbital-left temporal area (RSO-LTA). Therapeutic effects were assessed with the tinnitus functional index (TFI), a visual analogue scale (VAS) for tinnitus loudness, and the hyperacusis questionnaire (HQ) filled out pretherapy, posttherapy, and follow-up. With a new group of patients and in a similar way, the effects of HD tDCS of the right DLPFC were assessed, with the tinnitus questionnaire (TQ) and the hospital anxiety and depression scale (HADS) added. TFI total scores improved significantly after both tDCS and HD tDCS (DLPFC: P <.01; RSO-LTA: P <.01; HD tDCS: P =.05). In 32% of the patients, a clinically significant improvement in TFI was observed. The 2 tDCS groups and the HD tDCS group showed no differences on the evolution of outcomes over time (TFI: P =.16; HQ: P =.85; VAS: P =.20). TDCS and HD tDCS resulted in a clinically significant improvement in TFI in 32% of the patients, with the 3 stimulation positions having similar results.
The International Federation of Clinical Neurophysiology evidence-based guideline (2017) on the use of transcranial direct current stimulation did not recommend tDCS as a treatment for tinnitus. Studies suggested anodal tDCS of the left temporoparietal cortex was probably ineffective (level B evidence). A lack of data precluded any recommendation on the use of tDCS of the left dorsolateral prefrontal cortex as therapy for chronic tinnitus.
In 2014, the American Academy of Otolaryngology - Head and Neck Surgeons published evidence-based guidelines on tinnitus. The following were included in recommendations that pertain to this medical policy:
In 2024, the Department of Veterans Affairs and the Department of Defense published Clinical Practice Guideline for Tinnitus. The following were included in recommendations that pertain to this medical policy:
Reference List
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