Archived Policies - Medicine

Treatment of Tinnitus


Effective Date:09-15-2011

End Date:06-14-2014


Treatment of tinnitus using any of the following therapeutic modalities is considered experimental, investigational and unproven:

  • tinnitus maskers;
  • transcutaneous electrical stimulation;
  • transmeatal laser irradiation;
  • tinnitus retraining therapy (tinnitus habituation therapy);
  • electromagnetic energy;
  • transcranial magnetic stimulation or repetitive transcranial magnetic stimulation (rTMS); and
  • botulinum toxin A.

NOTE:  This policy does not address pharmacologic treatment of tinnitus, e.g., the use of amitriptyline or other tricyclic antidepressants.


Tinnitus describes the perception of any sound in the ear in the absence of an external stimulus and presents a malfunction in the processing of auditory signals; a hearing impairment, often noise-induced or related to aging, is commonly associated with tinnitus.  Clinically, tinnitus is subdivided into subjective and objective; the latter describes the minority of cases in which an external stimulus is potentially heard by an observer, for example by placing a stethoscope over the patient’s external ear.  Common causes of objective tinnitus include middle ear and skull-based tumors, vascular abnormalities, and metabolic derangements.  In the majority of cases, tinnitus is subjective and frequently self-limited.  In a small subset of patients with subjective tinnitus, its persistence leads to disruption of daily life.  While many patients habituate to tinnitus, others may seek medical care if the tinnitus becomes too disruptive.

Treatment is supportive in nature; there is no cure.  One treatment, called tinnitus masking therapy, has focused on use of devices worn in the ear that produce a broad band of continuous external noise that drowns out or masks the tinnitus.  Cognitive behavioral therapy may also be provided to improve coping skills, typically requiring four to six one-hour visits over an 18-month period.  Tinnitus retraining therapy, also referred to as tinnitus habituation therapy, is based on the theories of a researcher named Jastreboff.  Jastreboff proposes that tinnitus itself is related to the normal background electrical activity in auditory nerve cells, but the key factor is the subject’s unpleasant perception of the noise, which is governed by an abnormal conditioned response in the extra-auditory limbic system.  The goal of tinnitus retraining therapy is to retrain the subcortical and cortical centers involved in processing the tinnitus signals and habituate the subcortical and cortical response to the auditory neural activity.  In contrast to tinnitus masking, the auditory stimulus is not intended to drown out or mask the tinnitus, but set at a level such that the tinnitus can still be detected.  This strategy is thought to enhance habituation to the tinnitus by increasing the neuronal activity within the auditory system.  Treatment may also include the use of hearing aids to increase external auditory stimulation.  An ear-worn device (Neuromonics Tinnitus Treatment, Neuromonics, Australia) has been developed that is pre-recorded with selected relaxation audio and other sounds spectrally adapted to the individual patient’s hearing thresholds.  This is achieved by boosting the amplitude of those frequencies where an audiogram has shown the patient to have a reduced hearing threshold.  The Neuromonics Tinnitus Treatment has been cleared for marketing as a tinnitus masker through the Food and Drug Administration’s (FDA) 510(k) process, and is “intended to provide relief from the disturbance of tinnitus, while using the system, and with regular use (over several months) may provide relief to the patient whilst not using the system.”

Transcutaneous electrical stimulation to the external ear has also been investigated and is based on the observation that the electrical stimulation of the cochlea associated with a cochlear implant may be associated with a reduction in tinnitus.  Transmeatal low-power laser irradiation, electromagnetic energy, transcranial magnetic stimulation/repetitive transcranial magnetic stimulation (rTMS), and botulinum toxin A injections have also been evaluated.


Since tinnitus is a subjective symptom without a known physiologic explanation, randomized placebo-controlled trials are particularly important to validate the effectiveness of any treatment compared to the expected placebo effect.

2007 Update

Tinnitus Masker

While several large case series have reported positive results of tinnitus maskers, placebo-controlled trials are required to evaluate the extent of the expected placebo effect.  Erlandsson performed a clinical trial in which patients were randomized to receive either a masker or sham device; those receiving the sham device were falsely told that 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 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 (n=5l) with counseling in addition to the use of one of two different tinnitus maskers.  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 maskers has not been found to show a significant advantage compared to counseling alone.

Transcutaneous Electrical Stimulation Of The Ear

Two randomized trials of electrical stimulation were reported in the 1980s with negative results.  Dobie and colleagues reported on a randomized, double-blind crossover trial in which 20 patients received an active and disconnected placebo device.  Reduction in severity of tinnitus was reported in two of 20 patients with the active device and four of 20 patients with the placebo device.  Fifteen of the 20 patients reported no effect with either device.  Thedinger and colleagues reported on a single-blind crossover trial of 30 patients who received active or placebo stimulation over two weeks.  Only two of the 30 subjects obtained a true positive result.  Steenerson and Cronin reported on a large case series of 500 patients with tinnitus who were treated with electrical stimulation twice weekly for a total of six to ten visits.  Fifty-three percent of patients reported a significant benefit, defined as an improvement of at least two points on a ten-point scale of tinnitus intensity. 

Transmeatal Laser Irradiaton

Tauber and colleagues reported on the use of transmeatal low-level laser therapy for the treatment of chronic tinnitus in 35 patients randomized to receive five single-diode laser treatments at either 635 or 830 nm.  The authors reported 13 of 35 patients had reduced tinnitus loudness, while two patients reported absence of tinnitus.  However, this was not a placebo-controlled trial, and the authors noted that further study was needed. 

Tinnitus Retraining Therapy

While Jastreboff has published the theoretical rationale behind tinnitus-retraining therapy, no controlled trials were identified.  Other articles from 1993 to 1998 were identified, but these studies were either focused on tools to evaluate the results of tinnitus retraining or consisted of uncontrolled trials.  In a 2003 literature review update, one non-randomized, clinical trial of 108 cases assigned to five categories of tinnitus retraining therapy was identified.  However, no randomized studies were identified in the 2003 update.  An update in March 2005 reported one randomized controlled trial.  This trial compared tinnitus-coping group training to minimal contact interventions or a waiting-list control.  The authors reported significant improvements in the tinnitus coping group training over the waiting-list control group

Jastreboff again provides the rationale behind tinnitus-retraining therapy and maintains that it can be an effective method of treatment.  Two prospective non-randomized clinical assays were done by Herraiz and colleagues in an attempt to demonstrate the efficacy of tinnitus retraining therapy. The results of these assays concluded that tinnitus retraining is an effective treatment of tinnitus. A prospective quasi-randomized study by Henry and colleagues compared the efficacy of tinnitus retraining therapy and tinnitus masking among 123 subjects.  The study concluded that both tinnitus masking and tinnitus retraining are effective therapies, with tinnitus masking demonstrating constant gains and tinnitus retraining demonstrating incremental gains over the 18 month period.  None of these studies specifically supports the efficacy of tinnitus retraining therapy.  No new randomized, placebo-controlled trials were identified.

Electromagnetic Energy

Ghossaini and colleagues 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 for 30 minutes, three times a week for one month.  The authors found no significant changes in either group in pretreatment and post-treatment audiometric thresholds, Tinnitus Handicap Inventory scores or tinnitus rating scores, and concluded pulsed electromagnetic energy (27.12 MHz at 600 pulses/second) offered no benefit in the treatment of tinnitus.

Transcranial Magnetic Stimulation

Kleinjung et al. reported on a placebo-controlled cross-over study of low-frequency repetitive transcranial magnetic stimulation in 14 patients with chronic tinnitus.  Using a Magstim system, the authors applied transcranial magnetic stimulation to the area of increased metabolic activity in the auditory cortex as identified by fused positron emission tomography and magnetic resonance imaging data.  After one week of transcranial magnetic stimulation, 11 of 14 patients experienced a significant reduction in tinnitus (p <0.005), whereas the sham treatment did not result in a significant change.  Eight patients also reported reduced tinnitus six months after treatment.  The authors noted that the study results are useful to support the association of tinnitus to increased metabolic activity and may assist in identifying new tinnitus treatment possibilities.

Pridmore and colleagues provide the rationale behind transcranial magnetic stimulation and state that there is a good theoretical basis along with early research suggesting that this treatment may have potential.  Rossi and colleagues reported on a randomized, double blind, crossover placebo study to evaluate the effects of rTMS on chronic tinnitus.  Sixteen subjects participated in the study over a period of five days. Two participants dropped out for transient worsening of tinnitus.  Eight out of 14 responded.  The study concluded that active repetitive transcranial magnetic stimulation induced an overall significant but transient improvement of subjective tinnitus perception (35% of the basal score).  However, this study is small, and further investigation is needed.  No additional recent randomized, placebo-controlled trials were identified, and updates failed to identify any significant additional randomized studies or research.

Botulinum Toxin A

Stidham and colleagues explored the use of botulinum toxin A injections for tinnitus treatment under the theory that blocking the autonomic pathways could reduce the perception of tinnitus.  In the Stidham et al study, 30 patients were randomized in a double-blind study to receive either three subcutaneous injections of botulinum toxin A around the ear followed by placebo injections four months later, or placebo injections first followed by botulinum toxin A.  The authors reported seven patients had reduced tinnitus after the botulinum toxin A injections which was statistically significant when compared to the placebo groups in which only two patients reported reduced tinnitus (p<0.005).  The tinnitus handicap inventory scores were also significantly decreased between pretreatment and four months post-botulinum toxin A injections.  However, no other significant differences were noted when comparing the two treatments at one and four months after injections.  The authors noted larger studies are needed.  Also, study limitations, including size and lack of intent to treat analysis, limited interpretation of results.

A review of the literature was conducted based on the MEDLINE database for the period of June 2005 through August 2007.  No new randomized, placebo-controlled trials were identified.  Thus, the coverage position of this medical policy is unchanged.

2009 Update

Tinnitus Retraining Therapy

An industry-sponsored randomized study compared the efficacy of a customized acoustic stimulus for tinnitus retraining with counseling alone.  Fifty (of 88 subjects recruited) were found to meet the inclusion/exclusion criteria.  The mean length of time that their tinnitus had been disturbing was 3.6 years (range 0.2 to 23).  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 data set for analysis with a “last value carried forward.”  Mean scores on the Tinnitus Reaction Questionnaire (TRQ) improved over the twelve 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 TRQ scores.  Normalized visual analogue scores for tinnitus severity, general relaxation, and loudness tolerance were improved relative to both baseline and the control group’s scores at twelve months.  Perceived benefits were also greater with the customized acoustic stimulus.  Another publication from the developers of the device described results for the first 552 patients who had treatment at specialized clinics in Australia.  Patients were divided into three levels, based on complicating factors and proposed suitability for the treatment.  Tier 1 (237 patients) did not display any nonstandard or complicating factors.  Tier 2 (223 patients) 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 (greater than 50 dB).  Tier 3 (92 patients) 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, pulsitile tinnitus, Ménière’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 one patients, 60% of tier two patients, and 39% of tier three patients.  It was not reported if the reduction in symptoms persisted when treatment stopped.  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.

Electromagnetic Energy

A 2008 publication of a randomized placebo-controlled double-blind study with 60 patients reported no efficacy of laser therapy for tinnitus.

Transcranial Magnetic Stimulation (rTMS)

One randomized, double-blind, sham-controlled cross-over trial (16 patients) used low-frequency (1Hz) rTMS over the auditory association cortex (left temporoparietal region) for five days, with two weeks follow-up after (and between) each condition.  Two patients dropped out due to worsening of tinnitus (one from each condition); sham treatment resulted in a less than 10% improvement in visual analogue scale (VAS) over the 3-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.  Another small randomized sham controlled study (eight subjects) 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).  The authors reported that the response to treatment was negatively correlated (r=-0.62) with disease duration.

Kleinjung et al. reported results from a prospective observational study of rTMS for ten days over the primary auditory cortex (identified by magnetic resonance imaging) in 45 patients.  Forty percent of patients were classified as responders (five points or more on a tinnitus questionnaire) and 60% as non responders; 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.  Recent experimental studies, which are testing different locations and schedules along with beginning to identify the patient population that might benefit from this treatment, indicate that rTMS for tinnitus is investigational.

Transmeatal Laser Irradiation

A 2008 publication of a randomized placebo-controlled double-blind study with 60 patients reported no efficacy of laser therapy for tinnitus.

A search of peer-reviewed literature through August 2009 identified no new clinical trial publications or any additional information that would change the coverage position of this medical policy.  

2011 Update

A search of peer reviewed literature was conducted through June 2011.  Review of literature addressed below resulted in no change to the coverage position of this medical policy. 

Transcranial magnetic stimulation or repetitive transcranial magnetic stimulation (rTMS)

A small (n=19) randomized double-blinded sham-controlled parallel trial from Brazil that had six-month follow-up after rTMS was identified.  As earlier studies had showed improved outcomes in the absence of hearing impairment, only subjects with normal pure tone audiometry were included in this trial.  Five sessions of rTMS (17 minutes per session) were performed on five consecutive business days.  Placebo stimulation was performed with a sham coil system which mimics the sound of active stimulation, without producing a magnetic field.  Tinnitus severity on the THI showed a decrease from baseline (29.8) to 1-month (19.4) and 6-month (22.8) follow-up.  There was no change in the THI following sham stimulation (28.9 at baseline, 28.9 at 1 month, and 29.6 at 6 months).

In 2010, Anders et al. published results of a double-blinded randomized sham-controlled trial with 42 patients who had chronic, treatment resistant tinnitus and completed two weeks of rTMS treatment over the left primary auditory cortex.  An additional ten patients withdrew from the study before the end of treatment due to adverse effects such as headache, worsening of tinnitus or perceived lack of efficacy.  Tinnitus severity was measured at baseline, the end of treatment (week 2) and during follow-up at 6, 14, and 26 weeks.  The baseline THI was 37.1 for the active treatment and 26.5 for the sham treatment.  At the end of the stimulation phase, both active and sham groups showed a significant reduction in the symptoms of tinnitus as measured by the THI and Tinnitus Questionnaire.  In the active rTMS group, tinnitus severity with the THI was rated as 31.8 at two weeks, increasing to around 33 through the twenty-six weeks of follow-up.  In the sham group, the THI was 23.1 at week two, rising to 27.7 by twenty-six weeks.  A similar pattern was observed with the Tinnitus Questionnaire.  Interpretation of this study is limited due to the differences in baseline scores and improvement in the sham group immediately following treatment.  In addition, the clinical significance of a four-point change in the THI and three-point change in the tinnitus questionnaire is unclear.

Tinnitus Coping Therapy

A 2007 Cochrane review that identified six randomized trials in which 285 patients with tinnitus received cognitive behavioral therapy or a control condition (another treatment or wait list), was updated in 2010 with two additional trials and a total of 468 participants.  As was previously found, there was no significant difference in subjective tinnitus loudness between cognitive behavioral therapy and either no treatment or another intervention, but an improvement in quality of life.  The updated analysis found evidence that depression scores improved when comparing cognitive behavioral therapy to no treatment, but there was no evidence of benefit in depression scores when compared to other treatments (yoga, education, and minimal contact-education).

Tinnitus Masking:

A 2010 Cochrane review evaluated evidence for masking in the management of tinnitus in adults.  Included in the review were six randomized controlled trials (553 participants) that used noise-generating devices or hearing aids as the sole management tool or in combination with other strategies, including counseling.  Heterogeneity in outcome measures precluded meta-analysis of the data.  The risk of bias was medium in three studies and high in three studies.  The authors concluded that due to the lack of quality research and the common use of combined approaches (hearing therapy plus counseling), the limited data failed to show evidence of the efficacy of masking therapy in tinnitus management.


Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.



Medicare Coverage:

The information contained in this section is for informational purposes only.  HCSC makes no representation as to the accuracy of this information.  It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does have a national Medicare coverage position.

A national coverage position for Medicare may have been changed since this medical policy document was written.  See Medicare's National Coverage at <>.


Nakashima T, Ueda H, Misawa H et al. Transmeatal low-power laser irradiation for tinnitus. Otol Neurotol 2002; 23(3):296-300.

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):154-61.

Ghossaini S, Spitzer J, Mackins C et al. High-frequency pulsed electromagnetic energy in tinnitus treatment. Laryngoscope 2004; 114(3):495-500.

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):566-9.

Herraiz, C., Hernandez, F.J., et al.  Long term clinical trial of tinnitus retraining therapy.   Otolaryngology Head and Neck Surgery (2005, November) 133(5):774-9.

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Mazurek, B., Fischer, F., et al.  A modified version of tinnitus retraining therapy: observing long-term outcomes and predictors.  Audiology and Neuro-Otology (2006) 11(5):276-86.

Marcondes, F., Fregni, F., et al.  Tinnitus and brain activation: insights from transcranial magnetic stimulation.   Ear Nose and Throat Journal (2006 April) 85(4):233-4, 236-8.

Pridmore, S., Kleinjung, T., et al.  Transcranial magnetic stimulation: potential treatment for tinnitus?  Psychiatry and Clinical Neurosciences (2006 April) 60(2):133-8.

Langguth, B., Zowe, M., et al.  Transcranial magnetic stimulation for the treatment of tinnitus: a new coil positioning method and first results.  Brain Topography (2006 Summer) 18(4):241-7.

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Langguth, B., Hajak, G., et al.  Repetitive transcranial magnetic stimulation and chronic tinnitus. Acta Oto-Laryngolica Supplementum (2006 December) 556:102-5.

Henry, J.A., Loovis, C., et al.  Randomized clinical trial: Group counseling based on tinnitus retraining therapy.  Journal of Rehabilitation Research and Development (2007) 44(1):21-32.

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Treatment of Tinnitus.  Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2011 May) Therapy 8.01.39.

Policy History:

9/15/2011        Document updated with literature review.  Coverage unchanged.

11/15/2009      Revised/updated entire document.  No change in experimental, investigational and unproven coverage position.

11/15/2007      Revised/updated entire document. 

11/2004           New CPT/HCPCS code(s) added

12/2003           Revised/updated entire document. 

5/1993             Revised/updated entire document. 

5/1990             New medical document

Archived Document(s):

Title:Effective Date:End Date:
Treatment of Tinnitus10-15-201804-14-2019
Treatment of Tinnitus02-15-201810-14-2018
Treatment of Tinnitus09-15-201602-14-2018
Treatment of Tinnitus07-15-201509-14-2016
Treatment of Tinnitus06-15-201407-14-2015
Treatment of Tinnitus09-15-201106-14-2014
Treatment of Tinnitus11-15-200909-14-2011
Treatment of Tinnitus11-15-200711-14-2009
Treatment of Tinnitus12-01-200311-14-2007
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