Tinnitus is an auditory perception described as the experience of sound, in the ear or head, in the absence of external acoustic stimulation. Tinnitus can occur in one ear or both ears, and can be perceived to be occurring inside or outside the ear. Tinnitus can be a symptom of a condition that causes hearing loss, or it can exist without any hearing loss.  

This document addresses botulinum toxin injections, electromagnetic energy, hyperbaric oxygen therapy, tinnitus masking devices, tinnitus retraining therapy, transcranial magnetic stimulation, and transmeatal laser irradiation as treatments for the management of tinnitus.

Note: Please see the following related documents for additional information:

• BEH.00002 Transcranial Magnetic Stimulation as a Treatment of Depression and other Neuropsychiatric Disorders
• DRUG.00006 Botulinum Toxin
• MED.00005 Hyperbaric Oxygen Therapy (Systemic/Topical)
• MED.00023 Biofeedback and Neurofeedback
• MED.00046 Electrical Stimulation and Electromagnetic Therapy for Wound Healing

Investigational and Not Medically Necessary:

In the absence of underlying pathology, treatment of tinnitus with any of the following therapies is considered investigational and not medically necessary:

• Botulinum toxin injections
• Electromagnetic energy
• Hyperbaric oxygen therapy (HBOT)
• Tinnitus masking devices, including sequential phase shift sound cancellation therapy
• Tinnitus retraining therapy (TRT)
• Transcranial magnetic stimulation (rTMS)
• Transmeatal laser irradiation

The American Speech-Language-Hearing Association defines tinnitus as the perception of sound in one or both ears or in the head when no outside sound is present. Tinnitus can be described as sound in the ears, such as ringing, hissing, roaring, pulsing, or whistling, that can be a symptom of a condition that causes hearing loss, or can exist without any hearing loss. Tinnitus can be classified into two types: 1) subjective tinnitus, and 2) objective tinnitus. Since tinnitus is a subjective symptom without a known physiologic explanation, randomized non-treatment and, where possible, placebo-controlled trials are particularly important to validate the effectiveness of any proposed therapy. There are no proven treatment options for tinnitus, except when a treatable underlying pathology is identified (e.g. vascular or mechanical abnormality such as arteriovenous malformations, arteriosclerosis, Eustachian tube dysfunction, or temporomandibular joint/TMJ disease). There is a lack of evidence in the peer-reviewed medical literature to demonstrate the safety and efficacy of the following treatment modalities for the management of tinnitus.

Tinnitus Masking Devices

Tinnitus masking devices are proposed to give an individual a perceived sense of relief from the tinnitus sound. While Schleuning and colleagues (1980) reported several large case series with positive results of tinnitus masking devices, placebo-controlled trials are required to evaluate the extent of the expected placebo effect. Erlandsson (1987) performed a clinical trial in which patients were randomized to receive either a masking device or sham device; those receiving the sham device were falsely told it delivered a beneficial electrical current. Treatment response was based on responses to a questionnaire focusing on both changes in tinnitus level and nonspecific effects on mood, stress, and symptoms other than tinnitus. Neither the treatment nor placebo group reported a significant change in tinnitus intensity.

Stephens and Corcoran (1985) reported on a controlled study that assigned non-hearing-impaired subjects to either a control group (n=24) with limited counseling or a treatment group consisting of counseling in addition to the use of one of two different tinnitus masking devices (n=5l). Outcomes were assessed with a questionnaire. There were no significant differences among the control and treatment groups, leading the authors to conclude that treatment with masking devices has not been found to show a significant advantage compared to counseling alone.

Sequential phase shift sound cancellation, also referred to as phase-shift pure tone sound therapy has been described as a proposed treatment for predominant-tone tinnitus. This emerging treatment involves the use of a phase shift sound cancellation protocol where an individual's tinnitus is initially identified as to frequency (Hz) and amplitude (dB). A signal is fed to the individual via earphones from a device programmed at six degrees out of phase sequentially (i.e., 6 degrees, 12 degrees, 18 degrees, etc.) for 30 seconds each for 30 minutes or until 360 degrees is achieved. On May 16, 2006, the FDA granted 510(k) clearance to a Class II device called the Tinnitus Phase-Out™ (Tinnitus Control, Inc., New York, NY), a substantially equivalent device to a predicate tinnitus masking device, the Tinnitus Rx, used for delivery of the phase shift sound cancellation protocol. According to the FDA, the intended use of the device is to provide "temporary relief of tinnitus symptoms" (FDA, 2006).

In a small, industry-sponsored prospective, single-blinded, crossover study, Lipman and Lipman (2007) evaluated the use of phase shift sound cancellation treatment for predominant tone tinnitus. Sixty-one subjects with predominant tone tinnitus participated in two weeks of control and two weeks of phase-shift treatment. Frequency and intensity matching, pre- and post-treatment Tinnitus Handicap Inventory (THI) scores, and patient diaries were outcome measures. Initial volume comparisons showed a strong relationship between treatment and decrease in tinnitus intensity, with 57% of subjects achieving successful treatment. Thirty-seven percent decreased by one THI grade, five percent by two THI grades. Utilizing diaries, 42% of the subjects reported periods of complete residual inhibition (CRI) ranging from one hour to seven days (mean = two days). No periods of CRI were reported in control weeks. The investigators suggested that phase shift treatment significantly benefited the majority of the study subjects, and that the treatment protocol administered via the device may be a valuable tool for the treatment of predominant tone tinnitus. The authors concluded, however, that further long-term studies with home therapy are warranted to demonstrate the clinical efficacy of sequential phase shift sound cancellation treatment for tinnitus.

Vermeire and colleagues (2007) reported on the use of phase-shift pure tone sound treatment in a prospective study of patients (n=35) with predominantly pure tone tinnitus unresponsive to all previous treatment. The patients were initially treated with the Tinnitus Phase-Out System protocol three times in one week. If the patient noticed an improvement, the therapy was continued for six weeks with a home device customized to their specific treatment frequency. Twenty-one of the 35 patients (60%) responded positively to the initial therapy sessions. Tinnitus was assessed before treatment, after the three in-office Tinnitus Phase-Out System therapy sessions, and after six weeks of home use of the patient treatment device (PTD). Treatment outcomes were assessed utilizing the visual analogue score (VAS) loudness scale and the quality of life Tinnitus Questionnaire (TQ). Significant tinnitus reduction was obtained on VAS after three office Tinnitus Phase-Out System therapy sessions (before treatment: mean VAS = 6.4; after three therapy sessions: mean VAS = 4.9; p = 0.042) and after six weeks of home use of the PTD (mean VAS = 4.9; p = 0.005). When analyzing the mean TQ score over treatment, a significant improvement was reported in total score from pretreatment (mean TQ score = 41.9) to six weeks after home use of the PTD (mean TQ score = 36.4) (p = 0.003). The authors concluded that in view of the results obtained, this treatment protocol for tinnitus may provide the majority of patients with a significant improvement in their symptoms. However, further evaluation, comparing this specific treatment protocol with more general noise stimulation treatment, will assist in identifying the specific indications of this therapy for the treatment of tinnitus.

Bessman and colleagues (2009) reported the results from a two year follow-up pilot study of the efficacy of a tinnitus intensive therapy habituation program on subjective tinnitus. Twenty-five participants were recruited from a population admitted to a polyclinic tinnitus treatment program in western Germany. Based on auditory perception principles (using a tinnitus masker system) and neural habituation, the participants reported a significant reduction of tinnitus annoyance with a mean improvement over the two-year follow-up period of 72.1%. The authors concluded that despite these promising results, further investigation in a multicenter treatment project is required, taking into account the effect of social cognitive factors. Limitations of this pilot study include lack of a placebo group and the small sample size where participants were their own controls.

There is currently insufficient evidence in the peer-reviewed literature in the form of randomized, placebo-controlled studies with large sample sizes and long-term follow-up evaluation to demonstrate the efficacy of sequential phase shift sound cancellation therapy and other forms of tinnitus masking therapy for the treatment of tinnitus.

Tinnitus masking (masker) devices have been approved as Class II prosthetic devices by the U.S. Food and Drug Administration (FDA, rev. 2006). However, the Centers for Medicare and Medicaid Services National Coverage Determination concludes that "Tinnitus masking is considered an experimental therapy because of the lack of controlled clinical trials demonstrating effectiveness and the unstudied possibility of serious toxicity in the form of noise induced hearing loss" (CMS, NCD 50.6).

Tinnitus Retraining Therapy

Tinnitus retraining therapy (TRT), based on a neuro-physiological model of tinnitus originally proposed by Jastreboff (1993), involves the use of low level auditory broad-band tone generators and "directive" counseling to achieve "habituation." The aim of TRT is to redirect the brain's attentional focus away from the tinnitus signal.  In contrast to the typical use of "maskers," the noise therapy in TRT is set at a level such that the tinnitus can still be detectable. The therapy is thought to enhance habituation by increasing the neuronal activity within the auditory system so the tinnitus is difficult to detect.

Bartnik and colleagues (2001) described a study of 108 patients from a registry group of 516 patients with tinnitus.  The patients were divided into two groups: 68 patients with only tinnitus and 40 patients with tinnitus and hearing loss. Thirty-eight patients in the tinnitus only group were provided counseling and advised to avoid silence. The remaining 30 patients in the tinnitus only group were provided counseling and noise generators for "near" masking. In the second group of 40 patients with both tinnitus and hearing loss, 38 cases were given counseling and unilateral hearing aids; the remaining two cases were given counseling and bilateral hearing aids to amplify environmental sounds. Patients were measured before, during, and after the treatment using a standardized questionnaire developed by Jastreboff. A composite survey score was used to compare patients before and after treatment. In the first group (tinnitus only, counseling provided), significant improvement was reported by 80% of the patients. In the tinnitus only group who received counseling and noise generators for "near masking," 73% of the patients reported improvement in tinnitus symptoms. In the second group with both tinnitus and hearing loss, 87% of the patients reported subjective improvement in tinnitus with the use of counseling and hearing aids to amplify environmental sounds. There were no statistically significant differences in treatment results between the two groups. The authors concluded the type of device used in TRT had no impact on treatment outcome and white noise generators for "near masking" are not more effective than standard hearing aids. This study is limited by the lack of subject randomization and how the subset of 108 patients was recruited for inclusion in the study.

Kroner-Herwig and colleagues (2003) reported the first randomized study on the efficacy of what is termed "cognitive tinnitus coping training" using a group format. One group received intensive, 11 session cognitive behavioral therapy (CBT) (n=43), a second less intensively treated group (n=16) received, in group format, only two group sessions in which education on tinnitus and self-help strategies were provided. A third group (n=16) besides education, received 4 sessions of group relaxation therapy. Subjective ratings of improvement were obtained from patients along with tinnitus coping and disability assessments by questionnaires. A "control" group (n=20) of patients on a waiting-list for therapy was used for comparison. The first group receiving more intensive, 11 session CBT improved significantly in comparison to the waiting list control group while the minimal contact interventions did not differ from each other, but were superior to the waiting list control group in some outcome measures. The intensive therapy group outcome was somewhat superior to minimal interventions in two domains, but not superior in scores of disability reduction. In addition to the small sample size, this study is limited by the use of a "waiting list" assigned group as a non-treatment control group. A subsequent small randomized study by Kaldo and colleagues (2008) found that an internet-based self-help program was as effective as standardized group-based CBT for reducing tinnitus distress.

Robinson and colleagues (2008) conducted a randomized, waitlist-controlled trial testing the effect of a brief, "manualized" cognitive-behavioral group therapy on distress associated with tinnitus, quality of well-being, and psychological distress including depression. CBT included training in cognitive restructuring, activity planning, and relaxation training. Participants (n=65) were randomly assigned to receive eight weeks of manualized group CBT either immediately or after an eight-week waiting period. Participants completed outcome measures using a one-item Likert scale ("no problem" to "unbearable"), the Tinnitus Handicap Questionnaire (THQ), Tinnitus Reaction Questionnaire (TRQ), THI, and TQ at the time of their random assignment and at 8, 16, and 52 weeks later. The authors concluded that repeated-measure analysis of covariance revealed significant group-by-time interactions on measures of tinnitus distress and depression, indicating that CBT led to greater improvement in those symptoms. Limitations of this study include a significant heterogeneous mixture of participants, a high drop-out rate (24/65, 37%), use of blinded raters at the end of the study instead of throughout the entire study, and the absence of external validation of adherence to the treatment manual.  

Herraiz and colleagues (2005) reported their results of a prospective, non-randomized study (n=158) assessing the efficacy of TRT for tinnitus relief. VAS for intensity and the THI scores were evaluated prior to TRT using both cognitive and white noise generators. Patients were evaluated at the end of 12 months of therapy. The authors reported that 82% of TRT treated patients improved with a THI score reduced from 48% to 32% and mean VAS scores decreased from 6.6 to 5.3 (p<0.05) when compared with a control group. This study, however, is limited by lack of randomization, the small number of patients included in the comparison groups, the use of patients on a "wait list" as a control group, and self-reported outcomes subject to bias.

Henry and colleagues (2006) conducted a prospective, experimental, controlled trial to evaluate the clinical efficacy of tinnitus masking and TRT in U.S. military veterans with severe tinnitus. Patients with tinnitus of sufficient severity to justify 18 months of individualized treatment (n=123) were alternately placed into treatment with either tinnitus masking or TRT. Treatment was administered at 0, 3, 6, 12, and 18 months. Outcomes of treatment were evaluated primarily using three self-administered tinnitus questionnaires (THI, THQ, and Tinnitus Severity Index). Findings were presented from the three written questionnaires with respect to three categories of patients: describing tinnitus as a 'moderate,' 'big,' and 'very big' problem at baseline. Based on effect sizes, both groups showed significant improvement in outcomes measures, with significantly greater improvement in the TRT group than for the group that utilized tinnitus masking. The greatest improvement in TRT compared to tinnitus masking occurred in patients who began treatment with severe tinnitus. The benefits of TRT compared to tinnitus masking were modest for patients with moderate tinnitus. The authors suggested that both TRT and tinnitus masking are effective therapies for improving tinnitus. This study is limited, however, by the lack of a control group that received equal attention and time, accounting for the similar improvements in outcomes measures. The homogeneous nature of the study population, restricted to veterans, also limits the external validity of this study.

In a industry-sponsored randomized trial, Davis and colleagues (2008) compared the efficacy of a customized acoustic stimulus for tinnitus retraining (Neuromonics Tinnitus Treatment, Neuromonics Inc, Bethlehem, PA, U.S.A.) with counseling alone. Fifty subjects were recruited with a 3.6 years (range 0.2 to 23) mean length of time that their tinnitus had been disturbing. Patients were allocated into one of four groups: 1) customized acoustic stimulus at high intensity for two hours per day, 2) customized acoustic stimulus at a lower intensity, 3) tinnitus retraining therapy with a broadband stimulator and counseling, or 4) counseling alone. Subjects were instructed to listen to the devices for two hours per day at the time of day when symptoms were most severe and at a level that completely (Group 1) or partially (Group 2) masked the tinnitus; use of the devices averaged 1.8 hours per day (range 0.4 to 6.8). The two customized acoustic stimuli groups were combined in the analysis due to overlap in the self-administered stimulus intensity (absence of statistical difference between the groups). All patients lost to follow-up were included in the dataset of analysis with a "last value carried forward." Mean scores on a TRQ improved over the 12 months of the study for the customized acoustic stimuli. TRQ scores were not significantly improved in the control groups. At the six-month follow-up, 86% of patients in the customized acoustic stimuli groups had met the definition of success based on 40% improvement in the TRQ scores. Normalized visual analogue scores for tinnitus severity, general relaxation, and loudness tolerance were improved relative to both baseline and control group's scores at 12 months. Perceived benefits were also greater with the customized acoustic stimulus. Limitations of this study include the small sample and short-term follow-up. Another study from the developers of the device described results for the first 552 patients who had treatment at specialized clinics in Australia (Hanley, 2008). Patients were divided into three levels, based on complicating factors and proposed suitability for the treatment. Tier 1 (n=237) did not display any nonstandard or complication factors. Tier 2 (n=223) exhibited one or more of the following: psychological disturbance, a low level of tinnitus-related disturbance (TRQ score below 17) and/or moderately severe or severe hearing loss in one ear (>50 dB). Tier 3 (n=92) exhibited one or more of the following: "reactive" tinnitus, continued exposure to high levels of noise during treatment, active pursuit of compensation, multi-tone tinnitus, pulsatile tinnitus, Meniere's disease, and/or hearing loss of greater than 50 dB in both ears. Of the 552 patients who began therapy, 62 (11%) chose to discontinue treatment for refund and 20 (4%) were lost to follow-up. After an average treatment duration of 37 weeks, the TRQ was reported to be improved by greater than 40% in 92% of Tier 1 patients, 60% of Tier 2 patients, and 39% of Tier 3 patients. It was not reported if the reduction in symptoms persisted when treatment stopped. The authors concluded that controlled studies with long-term follow-up are needed to evaluate the durability of treatment and the relative contribution of generalized masking versus desensitization to these results.

Despite the suggested benefit of TRT reported in some of the peer-reviewed scientific literature, credible evidence is still lacking from randomized, controlled clinical trials comparing TRT with placebo therapies to sufficiently demonstrate the safety and efficacy of this therapy for the treatment of tinnitus.

Transmeatal Laser Irradiation

Low-level laser irradiation applied through the external acoustic meatus of the affected ear has been investigated as a treatment for tinnitus. In a prospective, randomized, double-blinded controlled study, Nakashima and colleagues (2002), reported the results of active transmeatal laser irradiation or placebo laser treatment administered once weekly for four weeks (six minute treatments) to 45 individuals (n=68 ears) with disabling unilateral or bilateral tinnitus. The authors concluded there was no significant difference in tinnitus between the active and the placebo group with regard to outcome measurements of loudness, duration, quality and annoyance of tinnitus before and after irradiation.

Tauber and colleagues (2003) reported on the use of transmeatal low-level laser irradiation therapy (laser TCL-system) for the treatment of chronic cochlear tinnitus and sensorineural hearing loss (n=35). Patients were randomized to receive five single diode laser treatments at either 635 or 830 nm.  After a follow-up period of six months, the authors reported 13 of the 35 irradiated patients had reduced tinnitus loudness, while two patients reported total absence of tinnitus. However, the researchers stated additional large, double-blind, placebo-controlled studies are needed to evaluate the therapeutic effectiveness of the TCL system for treatment of acute and chronic cochlear disorders.

In a prospective, randomized, double-blind study, Gungor and colleagues (2008) evaluated the effectiveness of laser irradiation in the treatment of patients with chronic unilateral or bilateral tinnitus (n=66 ears in 45 patients). A 5 mW laser with a wavelength of 650 nm, or placebo laser, was applied transmeatally for 15 minutes, once daily for a week. A questionnaire was administered which asked patients to score their symptoms on a five-point scale, before and two weeks after laser irradiation. A decrease of one scale point, regarding the loudness, duration and degree of annoyance of tinnitus, was accepted to represent an improvement. The authors reported an improvement in the loudness, duration and degree of annoyance of tinnitus, respectively, in up to 49%, 58% and 55% of the patients in the active laser group. No significant improvement was observed in the placebo laser group. The authors concluded that transmeatal, low power laser irradiation may be a useful option for the treatment of chronic tinnitus.

Cuda and colleagues (2008) studied the effects of combined counseling and low-level laser stimulation in a small prospective, randomized controlled study of patients (n=46) with chronic tinnitus. Participants in the low-level laser stimulation experimental group wore an ear-hooked laser cold light device directed at the entrance of the external auditory canal toward the eardrum. The placebo group received a device identical to the active one in terms of appearance and weight; it was impossible for any patient to detect the nature of the stimulation received because the laser irradiation did not cause any sensation. Both groups were instructed to use the device for 20 minutes per day, each day for three months. All patients of both groups were treated with the same standardized protocol of combined counseling. The THI questionnaire was submitted at the beginning and at the end of treatment. The investigators reported an improvement in THI scores in the entire sample after treatment, but more significantly in the group receiving low-level laser stimulation, with approximately 61.6% (n=16) of irradiated patients reporting a decrease by one class in tinnitus severity compared to 35% (n=7) of the placebo group. The investigators cited that the limited sample size studied and the random anomalous distribution of age, resulting in the group subject to laser stimulation being younger than the placebo group, must be considered when drawing conclusions from this preliminary data. Results should therefore be confirmed through a larger, multicenter controlled clinical trial with an accurate definition of indicators. In a subsequent randomized placebo-controlled double-blind study of patients (n=60) with tinnitus presenting as sensorineural hearing loss in the affected ear, Teggi and colleagues (2008) concluded that there was no efficacy of soft laser therapy as a therapeutic measure for tinnitus.

There continues to be insufficient evidence in the medical literature to support the use of transmeatal (low-level) laser irradiation therapy for the treatment of tinnitus. Additional large, randomized, double-blind studies are needed to demonstrate that low-level laser irradiation improves outcomes in the treatment of tinnitus.

Electromagnetic Energy

Ghossaini and colleagues (2004), reported on a randomized, double-blind placebo controlled study of 37 patients who received either placebo treatment or electromagnetic energy treatment with a Diapulse^® device (Diapulse Corporation of America, Great Neck, NY) for 30 minutes, three times a week for one month.  The authors found no significant changes in either group in pre-treatment and post-treatment audiometric thresholds, THI scores or tinnitus rating scores, and concluded pulsed electromagnetic energy (at 27.12 MHz at 600 pulses/second) offered no benefit in the treatment of tinnitus.

Transcranial Magnetic Stimulation (rTMS)

Researchers suggest that chronic tinnitus is associated with increased focal brain activity in the central auditory system. Low-frequency repetitive transcranial magnetic stimulation (rTMS) has been proposed as a method for treating brain hyperexcitability disorders by reducing cortical excitability. Kleinjung and colleagues (2005) reported on a small prospective, placebo-controlled, cross-over study of low frequency (1Hz) rapid rTMS in fourteen right-handed patients with chronic tinnitus. Using the Magstim^® Nerve Stimulator (The Magstim Company LTD, Woburn, MA, U.S.A.), rTMS was applied to an area of increased focal metabolic activity in the auditory cortex identified with fused positron emission tomography (PET-MR) imaging. After one week of rTMS, 11 of 14 patients experienced a significant reduction in tinnitus (p<0.0005) but no significant change for placebo treatment (p=0.336). Eight patients reported reduced tinnitus six months after treatment. The authors concluded that the preliminary study results are promising, but the study size is small and further investigation is needed to establish the efficacy and safety of rTMS in the treatment of tinnitus.

The current peer-reviewed published literature shows an increasing interest in the potential treatment of tinnitus with rTMS. In a randomized, double-blind, sham-controlled crossover trial (n=16), Rossi and colleagues (2007) utilized low frequency (1Hz) rTMS over the auditory associated cortex (left temporoparietal region) for patients that met the following inclusion criteria: unilateral or bilateral tinnitus for more than one year, normal neurological examination and normal cranial magnetic resonance. Patients were randomly assigned to receive active (n=8) or sham (n=6) rTMS as the first intervention. Each week of the intervention was followed by two weeks of observation. Clinical variables were sampled immediately after the end of active or sham treatment, and after weeks one and two. The crossover occurred after the first two weeks of observation. The authors reported that sham treatment resulted in a less than 10% improvement in VAS over the three-week assessment. The average improvement in VAS for active rTMS (about 35%) was maintained for one week following treatment. Of the 14 patients who completed the study, eight (57%) were classified as responders (25% or greater improvement in VAS); no baseline factors were found to be associated with a positive response. Two patients dropped out due to worsening of tinnitus. Limitations of this study include the small sample size, patient dropout rate (n=2 or 12%), and the lack of long-term follow-up.

Another small randomized sham controlled study (n=8) found a temporary (30 minutes or less) duration-dependent reduction in tinnitus in about 50% of subjects following a single 5-, 15- or 30-minute session of rTMS over temporoparietal areas associated with excessive tinnitus-related activity (guided by positron-emission tomography with and without intravenous lidocaine). In this study, the authors concluded that the response to treatment was negatively correlated (r=-0.62) with disease duration (Plewnia, 2007).

Kleinjung and colleagues (2007) conducted a prospective observational study (n=45) of low-frequency rTMS delivered in ten sessions to the left primary auditory cortex (identified by magnetic resonance imaging) in patients with chronic tinnitus. Treatment outcome was assessed with a tinnitus questionnaire. Forty percent of patients were classified as responders (five points or more on the tinnitus questionnaire) and 60% as nonresponders; improvement in symptoms was maintained for 90 days. Post-hoc analysis found that a positive response was associated with absence of a hearing impairment and disease duration of less than three years. The authors concluded that tinnitus-related neuroplastic changes might be less pronounced in subjects with normal hearing and a short history of complaints, explaining why those patients benefited more from rTMS treatment.

In a comparative, pilot study, Kleinjung and colleagues (2008) proposed the use of low-frequency rTMS of the temporal cortex as a new treatment strategy for patients with chronic tinnitus. The authors stated that a functional abnormality in tinnitus patients involves multiple brain structures used for attention and emotional processing, including the dorsolateral prefrontal cortex. Therefore, the authors suggested the use of a new rTMS treatment strategy for tinnitus patients consisting of a combination of high-frequency prefrontal and low-frequency temporal rTMS. A total of 32 patients received either low-frequency temporal rTMS or a combination of high-frequency prefrontal and low-frequency temporal rTMS. Treatment effects were assessed with a standardized TQ. The authors reported that during and immediately after stimulation, there was a significant reduction of the tinnitus score in both groups (p=0.016), however, no significant difference between the two stimulation protocols (p=0.828) was observed. An evaluation after three months suggested a "tendency toward tinnitus improvement" with a significant difference (p=0.08) between the two treatment conditions, including a more pronounced effect for the combined protocol (p=0.029). The authors concluded that these results support recent data that suggest that auditory and nonauditory brain areas are involved in tinnitus pathophysiology. However, as these conclusions were drawn from a pilot study without placebo controls, randomized controlled trials of larger patient populations are necessary to determine the safety and efficacy of combination therapy consisting of high-frequency prefrontal and low-frequency temporal rTMS for the treatment of tinnitus.

A randomized controlled trial by Khedr and colleagues (2008) compared the effect of different frequencies of rTMS (1 Hz, 10 Hz, 25 Hz and sham; occipital, 1 Hz), given daily over the left temporoparietal cortex for two weeks to 66 subjects (randomly divided into four treatment groups) with chronic tinnitus. Subjects were assessed using the THI scale, performing self-ratings of symptoms and audiometric measures of residual inhibition before, immediately after two weeks of treatment, and monthly thereafter for four consecutive months. The authors reported there were no significant differences in basal measures between the four groups of subjects. A two-factor ANOVA analysis revealed a significant "rTMS" x "time" interaction for all measures; this occurred because real rTMS produced greater improvement than sham. However, there was no significant difference between the responses to different frequencies of rTMS. The response to rTMS depended on the duration of tinnitus, as subjects who had tinnitus for the longest period of time were the least likely to respond to treatment. The authors concluded that daily sessions of rTMS over the temporoparietal cortex may be a useful treatment for tinnitus.

Despite the suggested benefit of rTMS reported in some of the recent peer-reviewed literature, sufficient evidence is lacking from randomized, controlled clinical trials comparing rTMS with placebo therapies that demonstrates a durable outcome benefit of rTMS therapy for the treatment of tinnitus.

Botulinum Toxin 

Botulinum toxin is suggested by some individuals to not only block acetylcholine, but to also inhibit release of other neurotransmitters and neuropeptides important in the autonomic pathway. It is postulated the blockage of autonomic pathways with botulinum toxin might have a favorable impact on the perception of tinnitus. In a randomized, double-blind study, Stidham and colleagues (2005) explored the use of botulinum toxin A injections for the treatment of tinnitus in thirty patients with unilateral or bilateral non-pulsatile tinnitus with no evidence of middle ear disease for greater than two months. The patients ranged in age from 31 to 73 years, with duration of symptoms from five months to 30 years, with a median duration of 72 months. Patients were recruited from an existing population under care at a single treatment center for a variety of conditions including primary tinnitus, hearing loss, and Ménierè's disease. Patients were randomized to receive three subcutaneous injections of botulinum toxin A near the ear followed by placebo injections four months later; a second group received placebo injections first followed by botulinum toxin A four months later. Included in the data analysis were twenty-six patients who completed both injections.

After injections, subjective patient responses to treatment were recorded at one month and again at four months. Following treatment with botulinum toxin A, subjective tinnitus improved in seven patients, worsened in three, and 16 were unchanged. Following placebo, two patients were improved, seven worsened, and 17 were unchanged. Comparison of subjective patient responses in the treatment and placebo groups was statistically significant (p<0.005). However, using the standardized THI scale to judge response to treatment, there was no difference at one month between active and placebo treatments. A THI marginal statistical difference was reached only in the comparison of pre-botulinum toxin A to 4 months post treatment (p=0.042). However, no other significant differences were noted when comparing the two treatments at one and four months after injections. This study is limited by its small patient numbers, lack of intent to treat analysis, as well as differing etiologies and lengths of tinnitus. The authors concluded a larger study is needed before drawing conclusions regarding the potential benefit of botulinum toxin A in the treatment of tinnitus.

Hyperbaric Oxygen Therapy (HBOT)

Hyperbaric oxygen therapy (HBOT) has been proposed as a treatment for tinnitus that frequently accompanies sensorineural hearing loss. In a meta-analysis of the peer-reviewed literature, Bennett and colleagues (2005) evaluated the safety and efficacy of hyperbaric oxygen therapy (HBOT) for the treatment of individuals with idiopathic sudden sensorineural hearing loss (ISSHL) and tinnitus. In a single trial, 50 subjects were assessed for improvement in hearing and tinnitus after treatment with HBOT. Despite reporting improvement in hearing, the significance of any improvement in a subjective rating of tinnitus following HBOT could not be assessed due to poor reporting. The authors concluded that due to the small study population, methodological shortcomings, and the poor reporting, there is a lack of clinical evidence of a "beneficial effect" of HBOT on the chronic presentation of tinnitus. A randomized controlled trial of "high methodological rigor is justified to define those patients (if any) who can be expected to derive most benefit from HBOT" (Bennett, 2005).

Summary

The American Academy of Audiology's (AAA) Audiologic Guidelines for the Diagnosis & Management of Tinnitus Patients (AAA, 2000), states that "prior to recommending or beginning any treatment for tinnitus, it is essential that a differential diagnosis be attempted. There are many factors that can cause and affect tinnitus and its perception that will influence the management plan and outcome of any treatment." The evaluation and "treatment of patients with tinnitus is most likely to succeed when a multidisciplinary approach is employed." The AAA states "that at this time there is no cure for most cases of tinnitus," however, "a number of treatment approaches that can be performed by audiologists have been described with various degrees of reported success" (AAA, 2000). According to the American Speech-Language-Hearing Association, "The most effective treatment for tinnitus is to eliminate the underlying cause. Because tinnitus can be a symptom of a treatable medical condition, medical or surgical treatment can take place to correct the tinnitus. Unfortunately, in many cases the cause of tinnitus cannot be identified, or medical or surgical treatment is not the appropriate course of action. In these cases, the tinnitus itself may need to be treated" (ASHA, 2009).

Available studies have failed to consistently demonstrate the use of botulinum toxin A injections, electromagnetic energy, hyperbaric oxygen therapy, sequential phase shift sound cancellation, tinnitus masking devices, tinnitus retraining therapy (TRT), transcranial magnetic stimulation (rTMS), and transmeatal laser irradiation as safe and effective treatment modalities for tinnitus. There is a lack of well-designed, randomized controlled clinical trials demonstrating these treatments eliminate tinnitus more frequently than placebo, or provide replicable long-term reduction in the impact of tinnitus on everyday life in excess of placebo effects (AAA, 2000).

Tinnitus describes the perception of any sound in the ear in the absence of an external stimulus and represents a malfunction in the processing of auditory signals; hearing impairment, often noise-induced or related to aging, is commonly associated with tinnitus. Almost everyone at one time or another has experienced brief periods of mild ringing or other sound in the ear. Some individuals have more annoying and constant types of tinnitus. One third of all adults report experiencing tinnitus at some time in their lives. Ten percent to 15% of adults have prolonged tinnitus requiring medical evaluation (Heller, 2003). Prevalence estimates of individuals with tinnitus vary widely, from 7.9 million (2) to more than 37 million (Noell, 2003). Clinically, tinnitus is subdivided into subjective and objective; the latter describes a very small minority of cases in which an external stimulus is potentially heard by an observer, for example, by placing a stethoscope over the individual's external ear. Common causes of objective tinnitus include middle ear and skull-based tumors, vascular tumors and malformations, and contractions of the palatal muscles. Treatment of objective tinnitus is dictated by the identified underlying disorder.

Distinguishing between objective and subjective tinnitus is essential to its successful diagnosis and management. In the majority of cases, tinnitus is subjective and frequently self-limited. In a small subset of individuals with subjective tinnitus, its persistence leads to disruption of daily life. While many individuals adjust to tinnitus, others may seek medical care if the tinnitus becomes too disruptive. Data from the American Tinnitus Association (2009) points to a prevalence of tinnitus in about 50 million, or 20% of the American population. Between 0.5% and 3% of the adult population may suffer from severe chronic tinnitus which can seriously affect their normal lives by producing mood disorders, anxiety, depression or altered sleep (Anderson, 2004). Tinnitus can occur as an isolated symptom without a recognizable cause or in association with middle or inner ear disease such as sensorineural hearing loss, otosclerosis, drug-related toxicity (antimicrobials, chemotherapeutic agents, loop diuretics, nonsteroidal anti-inflammatory-NSAIDs, or salicylates), sudden deafness and Ménierè's disease. Environmental factors include acute acoustic trauma, exposure to occupational noise, and overly amplified music. Other causes of subjective tinnitus include neurological events or disorders (head injury, vestibular schwannoma), infectious processes (otitis media, meningitis), or conditions such as temporomandibular joint (TMJ) disorder. Psychological and psychosocial conditions such as depression, phonophobia, and social isolation may accompany tinnitus symptoms.

Treatment of subjective tinnitus is supportive in nature; no single treatment has been demonstrated as an effective cure. Multiple pharmacotherapies have been tried to treat tinnitus including lidocaine, antidepressants, anticonvulsants, anxiolytics, antihistamines, antioxidants, herbs, vitamins and minerals. Others treatments have focused on CBT, counseling, music therapy and the use of hyperbaric oxygen therapy or use of tinnitus masking devices that produce a broad band of continuous external noise that diverts attention or masks the tinnitus. Masking devices set at a level such that the tinnitus can still be detected are used to induce habituation. Transmeatal low-power laser irradiation and electromagnetic energy have also been evaluated as treatments for tinnitus. Recent studies have looked at the impact of repetitive transcranial magnetic stimulation (rTMS), subcutaneous injections of botulium toxin A, and sequential phase shift sound cancellation treatment for the treatment of tinnitus.

Tinnitus retraining therapy (TRT) is a method for treating tinnitus based on a neurophysiologic model of tinnitus proposed by Pawel Jastreboff.  This model proposes involvement of the limbic and autonomic nervous systems "in all cases of clinically significant tinnitus and points out the importance of both conscious and subconscious connections governed by principles of conditioned reflexes" (Jastreboff, 1993). It is proposed that tinnitus results from the abnormal processing of signals generated in the auditory system.  This abnormal processing occurs before the signal is perceived centrally resulting in feedback whereby the annoyance created by the tinnitus causes the individual to focus increasingly on the noise.  In this model tinnitus could result from continuous firing of cochlear fibers, hyperactivity of cochlear hair cells or from damage to these cells creating a "phantom" sound-like signal the brain "believes" it is hearing. This process has been compared to chronic pain of central origin or "auditory" pain. 

Tinnitus retraining therapy, also referred to as tinnitus habituation therapy, focuses on counseling and behavioral retraining on the associations induced by tinnitus perception. The goal of this therapy is "to induce changes in the mechanisms responsible for transferring the tinnitus signal from the auditory system to the limbic and autonomic nervous systems, and thereby remove tinnitus-induced reactions" (Jastreboff, 2006). Counseling may require 4-6 hourly sessions over an 18-month period. 

Sequential phase shift sound cancellation treatment involves the use of a portable treatment device, classified by the FDA as a tinnitus masker, for the temporary relief of tinnitus symptoms. The Tinnitus Phase-Out device consists of a personalized sound recorded directly onto the treatment device. Using computer software, a hearing professional analyzes the audio characteristics of the individual's tinnitus. The sound pattern is then matched to the individual's specific pitch and volume level. The unique technology is then programmed into the individual's treatment device. The phase-shift audio technology is applied to create a treatment program that is suggested to significantly reduce, or in some cases eliminate, the individual's perception of tinnitus.

Cognitive behavioral therapy (CBT): therapy directed at teaching coping strategies, distraction skills and relaxation techniques so that the psychological response to tinnitus may be altered

Objective tinnitus: internal sounds that may be audible to an observer with a stethoscope or other auscultation device placed over the head and neck structures near the individual's ear

Subjective tinnitus: the false perception of noise that is heard only by an individual in the absence of acoustic stimulation of the cochlea

Tinnitus: a perception of sound in the head when no outside sound is present; typically referred to as "ringing in the ears" or "head noise," but other forms of sound have been described such as hissing, roaring, pulsing, whooshing, chirping, whistling and clicking

Tinnitus Handicap Inventory (THI): a tinnitus measurement scale developed by Newman and colleagues in 1996; provides data and interpretation of the individual's current tinnitus status; measures the individual's-reported burden or handicap of tinnitus in three dimensions: functional or role limitations, emotional or affective responses, and the catastrophic or desperation of the individual's inability to escape the symptoms of tinnitus

Tinnitus Handicap Questionnaire (THQ): a tinnitus measurement questionnaire developed by Kuk and colleagues in 1990; a standardized research scale measuring the burden or handicap of tinnitus in three reported factors: effects of tinnitus on the individual's social and emotional behaviors, the individual's hearing ability/difficulty related to tinnitus, and the individual's view if tinnitus had worsened (e.g. if the outlook was healthy, if help was available, and if others were aware of the nature of tinnitus)

Tinnitus Reaction Questionnaire (TRQ): a scale designed to assess the psychological distress associated with tinnitus

The following codes for treatments and procedures applicable to this document are included below for informational purposes.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy.  Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational and Not Medically Necessary:
For the following procedure and diagnosis codes, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

Peer Reviewed Publications:

1. Bartnik G, Fabijanska A, Rogowski M. Effects of tinnitus retraining therapy (TRT) for patients with tinnitus and subjective hearing loss versus tinnitus only. Scand Audiol Suppl. 2001; (52):206-208.
2. Bennett M, Kertesz T, Yeung P. Hyperbaric oxygen therapy for idiopathic sudden sensorineural hearing loss and tinnitus: a systemic review of randomized controlled trials. J Laryngol Otol. 2005; 119(10):791-798.
3. Bessman P, Heider T, Watten VP, Watten RG. The tinnitus intensive therapy habituation program: a 2-year follow-up pilot study on subjective tinnitus. Rehabil Psychol. 2009; 54(2):133-137.
4. Cuda D, De Caria A. Effectiveness of combined counseling and low-level laser stimulation in the treatment of disturbing chronic tinnitus. Int Tinnitus J. 2008; 14(2):175-180.
5. Davis PB, Wilde RA, Steed LG, Hanley PJ. Treatment of tinnitus with a customized acoustic neural stimulus: a controlled clinical study. Ear Nose Throat J. 2008; 87(6):330-339.
6. Erlandsson S, Ringdahl A, Hutchins T, et al. Treatment of tinnitus: a controlled comparison of masking and placebo. Br J Audiol. 1987; 21(1):37-44.
7. Ghossaini S, Spitzer J, Mackins C, et al. High-frequency pulsed electromagnetic energy in tinnitus treatment. Laryngoscope. 2004; 114(3):495-500.
8. Gungor A, Dogru S, Cincik H, et al. Effectiveness of transmeatal low power laser irradiation for chronic tinnitus. J Laryngol Otol. 2008; 122(5):447-451.
9. Hanley PJ, Davis PB, Paki B, et al. Treatment of tinnitus with a customized, dynamic acoustic neural stimulus: clinical outcomes in general private practice. Ann Otol Rhinol Laryngol. 2008; 117(11):791-799.
10. Heller AJ. Classification and epidemiology of tinnitus. Otolaryngol Clin North Am. 2003; 36(2):239-248.
11. Henry JA, Loovis C, Montero M, et al. Randomized clinical trial: group counseling based on tinnitus retraining therapy. J Rehabil Res Dev. 2007; 44(1):21-32.
12. Henry JA, Schechter MA, Zaugg TL, et al. Clinical trial to compare tinnitus masking and tinnitus retraining therapy. Acta Otolaryngol Suppl. 2006; (556):64-69.
13. Herraiz C, Hernandez FJ, Plaza G, de los Santos G. Long-term clinical trial of tinnitus retraining therapy. Otolaryngol Head Neck Surg. 2005; 133:774-779.
14. Jastreboff PJ, Hazell JW. A neurophysiological approach to tinnitus: clinical implications. Br J Audiol. 1993; 27(1):7-17.
15. Jastreboff PJ, Jastreboff MM..Tinnitus retraining therapy for patients with tinnitus and decreased sound tolerance. Otolaryngol Clin North Am. 2003; 36(2):321-336.
16. Jastreboff PJ, Jastreboff, MM. Tinnitus retraining therapy: a different view on tinnitus. ORL. 2006; 68(1):23-29.
17. Kaldo V, Levin S, Widarsson J, et al. Internet versus group cognitive-behavioral treatment of distress associated with tinnitus: a randomized controlled trial. Behav Ther. 2008; 39(4):348-359.
18. Khedr EM, Rothwell JC, Ahmed MA, El-Atar A. Effect of daily repetitive transcranial magnetic stimulation for treatment of tinnitus: comparison of different stimulus frequencies. J Neurol Neurosurg Psychiatry. 2008; 79(2):212-215.
19. Kleinjung T, Eichhammer P, Landgrebe M, et al. Combined temporal and prefrontal transcranial magnetic stimulation for tinnitus treatment: a pilot study. Otolaryngol Head Neck Surg. 2008; 138(4):497-501.
20. Kleinjung T, Eichhammer P, Langguth B, et al. Long term effects of repetitive transcranial magnetic stimulation (rTMS) in patients with chronic tinnitus. Otolaryngol Head Neck Surg. 2005; 132(4):566-569.
21. Kleinjung T, Steffens T, Sand P, et al. Which tinnitus patients benefit from transcranial magnetic stimulation? Otolaryngol Head Neck Surg. 2007; 137(4):589-595.
22. Kroner-Herwig B, Frenzel A, Fritsche G, et al. The management of chronic tinnitus: comparison of an outpatient cognitive-behavioral group training to minimal-contact interventions. J Psychosom Res. 2003; 54(4):381-389.
23. Lipman RI, Lipman SP. Phase-shift treatment for predominant tone tinnitus. Otolaryngol Head Neck Surg. 2007; 136(5):763-768.
24. Nakashima T, Ueda H, Misawa H, et al. Transmeatal low-power laser irradiation for tinnitus. Otol Neurotol. 2002; 23(3):296-300.
25. Noell CA, Meyerhoff WL. Tinnitus. Diagnosis and treatment of this elusive symptom. Geriatrics. 2003; 58(2):28-34.
26. Plewnia C, Reimold M, Najib A, et al. Dose-dependent attenuation of auditory phantom perception (tinnitus) by PET-guided repetitive transcranial magnetic stimulation. Hum Brain Mapp. 2007; 28(3):238-246.
27. Robinson SK, Viirre ES, Bailey KA, et al. A randomized controlled trial of cognitive-behavior therapy for tinnitus. Int Tinnitus J. 2008; 14(2):119-126.
28. Rossi S, De Capua A, Ulivelli M, et al. Effects of repetitive transcranial magnetic stimulation on chronic tinnitus: a randomised, crossover, double blind, placebo controlled study. J Neurol Neurosurg Psychiatry. 2007; 78(8):857-863.
29. Schleuning AJ, Johnson RM, Vernon JA. Evaluation of a tinnitus masking program: a follow-up study of 598 patients. Ear Hear. 1980; 1(2):71-74.
30. Stephens SDG, Corcoran AL. A controlled study of tinnitus masking. Br J Audiol. 1985; 19(2):159-167.
31. Stidham KR, Solomon PH, Roberson JB. Evaluation of botulinum toxin A in the treatment of tinnitus. Otolaryngol Head Neck Surg. 2005; 132(6):883-889.
32. Tauber S, Schorn K, Beyer W, et al. Transmeatal cochlear laser treatment of cochlear dysfunction: a feasibility study for chronic tinnitus. Laser Med Sci. 2003; 18(3):154-161.
33. Teggi R, Bellini C, Piccioni LO, et al. Transmeatal low-level laser therapy for chronic tinnitus with cochlear dysfunction. Audiol Neurootol. 2009; 14(2):115-120.
34. Vermeire K, Heyndrickx K, De Ridder D, Van de Heyning P. Phase-shift tinnitus treatment: an open prospective clinical trial. B-ENT. 2007; 3(7):65-69.

Government Agency, Medical Society, and Other Authoritative Publications:

1. American Academy of Audiology (AAA). Audiologic guidelines for the diagnosis and management of tinnitus patients. October 18, 2000. Available at: http://www.audiology.org/resources/documentlibrary/Pages/TinnitusGuidelines.aspx. Accessed on February 4, 2010.
2. Centers for Medicare and Medicaid Services (CMS). National Coverage Determination: Tinnitus masking. NCD #50.6. Effective date not posted. Available at: http://www.cms.hhs.gov/mcd/index_list.asp?list_type=ncd. Accessed on February 4, 2010.
3. U.S. Food and Drug Administration (FDA). 510(k) Premarket Notification Database. Masker, Tinnitus. Product Code KLW. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm. Accessed on February 4, 2010.

1. American Speech-Language-Hearing Association (ASHA). Tinnitus. Available at: http://www.asha.org/public/hearing/disorders/Tinnitus.htm. Accessed on February 4, 2010.
2. American Speech-Language-Hearing Association (ASHA). Treatment and rehabilitation. Tinnitus management. Available at: http://www.asha.org/public/hearing/treatment/. Accessed on February 4, 2010.
3. American Tinnitus Association (ATA). Available at: http://www.ata.org. Accessed on February 4, 2010.
4. National Institute on Deafness and Other Communication Disorders (NIDCD). The noise in your ears: facts about tinnitus. February 2001. Available at: http://www.nidcd.nih.gov/health/hearing/noiseinear.asp. Accessed on February 4, 2010.

Cognitive Behavioral Therapy
Diapulse®
Electromagnetic Energy
Hyperbaric Oxygen Therapy
Magstim® Nerve Stimulator
Neuromonics Oasis™ Device
Sequential Phase Shift Sound Cancellation
Tinnitus
Tinnitus Intensive Therapy
Tinnitus Masker
Tinnitus Masking Device
Tinnitus Phase-Out™ Treatment
Tinnitus Retraining Therapy
Transcranial Magnetic Stimulation
Transmeatal Laser Irradiation

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.