Archived Policies - Medicine


Treatment of Tinnitus

Number:MED205.022

Effective Date:11-15-2007

End Date:11-14-2009

Coverage:

Treatment of tinnitus with tinnitus maskers, transcutaneous electrical stimulation, transmeatal laser irradiation, tinnitus retraining therapy, electromagnetic energy, transcranial magnetic stimulation and botulinum toxin A is considered experimental, investigational and unproven.

Description:

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.  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 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 and botulinum toxin A injections have also been evaluated.

Tinnitus retraining, also referred to as tinnitus habituation therapy, is another treatment option, 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.  This perception is governed by an abnormal conditioned response in the extra-auditory limbic system.  Tinnitus retraining focuses counseling and behavioral retraining on the associations induced by tinnitus perception.  Specifically, the goal is not to eliminate the tinnitus itself, but to retrain the subcortical and cortical centers involved in processing the tinnitus signals.  The counseling may require four to six one-hour visits over an 18-month period.  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.

Rationale:

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.

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.

2007 Update

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 is unchanged.

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.

2007 Update

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 is unchanged.

TRANSMEATAL LASER IRRADIATON

A randomized study reported that there was no significant difference in tinnitus between the active or placebo group.  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.

2007 Update

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 is unchanged.

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

2007 Update

A review of the literature was conducted based on the MEDLINE database for the period of June 2005 through August 2007.  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. Thus the coverage position is unchanged.

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 (at 27.12 MHz at 600 pulses/second) offered no benefit in the treatment of tinnitus.

2007 Update

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 is unchanged.

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.

2007 Update

A review of the literature was conducted based on the MEDLINE database for the period of June 2005 through August 2007.  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 repetitive transcranial magnetic stimulation 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. Thus the coverage position is unchanged.

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.

2007 Update

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 is unchanged.

Contract:

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.

Coding:

None


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.

Medicare (CMS) does have a national coverage position.

A national coverage position for Medicare may have been developed or changed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

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.

Jastreboff, P.J., and M.M. Jastreboff.  Tinnitus retraining therapy: a different view on tinnitus.    ORL: Journal for Oto-Rhino-Laryngology and Its Related Specialties (2006) 68(1):23-9.

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.

Treatment of Tinnitus. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2006 February) Therapy 8.01.39.

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.

Fregni, F., Marcondes, R., et al.  Transient tinnitus suppression induced by repetitive transcranial magnetic stimulation and transcranial direct current stimulation.  European Journal of Neurology (2006 September) 13(9):996-1001.

Richter, G.T., Mennemeier, M., et al.  Repetitive transcranial magnetic stimulation for tinnitus: a case study.  The Laryngoscope (2006 October) 116(10):1867-72.

Caffier, P.P., Haupt, H., et al.  Outcomes of long-term outpatient tinnitus-coping therapy: psychometric changes and value of tinnitus-control instruments.  Ear and Hearing (2006 December) 27(6):619-27.

Folmer, R.L., Carroll, J.R., et al.  Effects of repetitive transcranial magnetic stimulation (rTMS) on chronic tinnitus.  Acta Oto-Laryngolica Supplementum (2006 December) 556:96-101.

Henry, J.A., Schechter, M.A., et al.  Clinical trial to compare tinnitus masking and tinnitus retraining therapy.  Acta Oto-Laryngolica Supplementum (2006 December) 556:64-9.

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.

Siedentopf, C.M., Ischebeck, A., et al.  Neural correlates of transmeatal cochlear laser (TCL) stimulation in healthy human subjects.  Neuroscience Letters (2007 January 16) 411(3):189-93.

Plewnia, C.,  Reimold, M., et al.  Moderate therapeutic efficacy of positron emission tomography-navigated repetitive transcranial magnetic stimulation for chronic tinnitus: a randomized controlled pilot study.  Journal of Neurology, Neurosurgery and Psychiatry (2007 February) 78(2):152-6.

Plewnia, C.,  Reimold, M., et al.  Dose-dependent attenuation of auditory phantom perception (tinnitus) by PET-guided repetitive transcranial magnetic stimulation.  Human Brain Mapping (2007 March) 28(3):238-46.

Smith, J.A., Mennemeier, M., et al.  Repetitive transcranial magnetic stimulation for tinnitus: a pilot study.  The Laryngoscope (2007 March) 117(3):529-34.

Langguth, B., Kleinjung, T., et al.  Transcranial stimulation for the treatment of tinnitus: effects on cortical excitability.  BMC Neuroscience (2007 July 2) 8:45.

Herraiz, C., Hernandez, F.J., et al.  Tinnitus retraining therapy: prognosis factors.  American Journal of Otolaryngology (2007 July-August) 28(4):225-9.

Rossi, S.,  De Capua, A., et al.  Effects of repetitive magnetic stimulation on chronic tinnitus: a randomized, crossover, double blind placebo controlled study.  Journal of Neurology, Neurosurgery and Psychiatry (2007 August) 78(8):857-63.

Policy History:

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
Back to Top