Tinnitus is an auditory perception described as the experience of sound, in the ear or head, in the absence of external acoustic stimulation.  Up to 18% of the general population in industrialized countries is affected by tinnitus. This policy addresses various treatments for tinnitus, including tinnitus maskers, electrical stimulation, laser irradiation, tinnitus retraining therapies, botulinum toxin A, and transcranial magnetic stimulation.

For related policies please see the following:

• DRUG.00006 Botulinum Toxin
• MED.00043 Low Level Laser Therapy
• MED.00046 Electrical Stimulation and Electromagnetic Therapy for Wound Healing
• BEH.00002 Transcranial Magnetic Stimulation as a Treatment of Depression and other Psychiatric Disorders

Investigational/Not Medically Necessary:

Treatment of tinnitus with tinnitus maskers, electrical stimulation, laser irradiation, tinnitus retraining therapy, botulinum toxin A, or transcranial magnetic stimulation is considered investigational/not medically necessary.

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.

Tinnitus Masker

While Schleuning and colleagues (1980) reported several large case series with positive results of tinnitus maskers, 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 masker 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 1 of 2 different tinnitus maskers (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 maskers has not been found to show a significant advantage compared to counseling alone. No recent randomized, placebo-controlled trials were identified in a literature search. The Center of Medicaid and Medicare Services national coverage position 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 Medicare Coverage Database, 2006). 

Transcutaneous Electrical Stimulation of the Ear

Two randomized trials of electrical stimulation were reported in the 1980s with negative results. Dobie and colleagues (1986) 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 2 of 20 patients with the active device and 4 of 20 patients with the placebo device. Fifteen of the 20 patients reported no effect with either device. Thedinger and colleagues (1987) reported on a single-blind crossover trial of 30 patients who received active or placebo stimulation over 2 weeks. Only 2 subjects of the 30 obtained a true positive result.

Recently, Steenerson and Cronin (1999) reported on a large case series of 500 patients with tinnitus who were treated with electrical stimulation twice weekly for a total of 6 to 10 visits.  Fifty-three percent of patients reported a significant benefit, defined as an improvement of at least 2 points on a 10-point scale of tinnitus intensity. Despite the favorable results, case series cannot be used as evidence of treatment efficacy, particularly when a placebo effect is anticipated. 

Transmeatal Laser Irradiation

A randomized study by Nakashima in 2002, reported there was no significant difference in tinnitus between the active and the placebo group. In a 2005 update, 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 5 single diode lasers treatments at either 635 or 830 nm.  The authors reported 13 of 35 patients had reduced tinnitus loudness, while 2 patients reported absence of tinnitus. However, this was not a placebo controlled trial and the authors noted further study is needed.

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 for 30 minutes, 3 times a week for 1 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.

Transcranial Magnetic Stimulation

Kleinjung (2005) reported on a small prospective placebo controlled cross-over study of low frequency (1Hz) rapid repetitive transcranial magnetic stimulation (rTMS) in fourteen right-handed patients with tinnitus rated from “mild” to “extreme”. All patients had bilateral tinnitus for at least one year which failed multiple standard treatments. Patients with other neurological or psychiatric diseases were excluded as were those for whom the use of magnetic stimulation is contraindicated, e.g., cardiac pacemaker or metallic implants. Using the Magstim® Nerve Stimulator (The Magstim Company LTD, Winchester, MA.), rTMS was applied to an area of increased focal metabolic activity in the auditory cortex identified with fused PET-MR imaging.  Patients were blinded regarding the stimulus condition. Sham stimulation used a specific sham-coil which reproduced the “popping” sound of the discharge associated with the treatment coil.  After initial randomization, patients and investigators were blinded regarding stimulus conditions. The patients were treated at a rate of 1 Hz over 5 days with 2000 stimuli/day. After a 7-day interval without treatment, sham stimulation followed during the third week. Individuals began their 3 week treatment randomly assigned to either active or sham stimulation.  A standardized tinnitus survey score (TQ-Score Goebel G 1994) was assessed twice at baseline, immediately after the each rTMS treatment, and at 3, 6 and 180 days after treatment. The patients were followed for 6 months.  

The mean tinnitus questionnaire score (TQ-Score) before rTMS was compared to mean values after therapy and showed a significant (P<0.0005) difference for active treatment but no significant change for placebo treatment (P=0.336). Reduction in TQ-score was seen in 11 of 14 patients, and the positive effect of rTMS could be seen 6 months after therapy where comparison of mean values before and after remained significantly different (P<0.05). Eight patients reported reduced tinnitus 6 months after treatment. There was no association between order of treatment (first placebo vs. first active stimulation) and treatment response. The duration of tinnitus prior to therapy had no bearing on the effects of rTMS. The results of this preliminary study 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.

Botulinum Toxin A

Botulinum toxin A is felt by some 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 A might have a favorable impact on the perception of tinnitus. Stidham (2005) explored the use of botulinum toxin A injections for tinnitus treatment in a study of 30 patients randomized in a double-blind study to receive 3 subcutaneous injections of botulinum toxin A near the ear followed by placebo injections 4 months later while a second group received placebo injections first followed by botulinum toxin A four months later. Twenty-six patients completed both injections and these were included in the data analysis.  The patients ranged in age from 31 to 73 years with duration of symptoms from 5 months to 30 years with a median duration of 72 months.  Patients were recruited from an existing patient population under care at a single center for a variety of problems including primary tinnitus, hearing loss, and Ménierè’s disease. Patients were referred for the study by their treating physicians.  Patients were required to have unilateral or bilateral non-pulsatile tinnitus with no evidence of middle ear disease for greater than 2 months.

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 7 patients, worsened in 3, and 16 were unchanged. Following placebo, 2 patients were improved, 7 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 the Tinnitus Handicap Inventory (THI) scale (Newman, 1996) 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). In addition, none of the other comparisons of pretreatment to one month or pretreatment to 4 months showed a treatment effect: tinnitus loudness, pitch, hearing, and a tinnitus questionnaire. This study is limited by its small size, lack of intent to treat analysis, as well as differing etiologies and lengths of tinnitus. The authors conclude a larger study is needed before drawing conclusions regarding the potential benefit of botulinum toxin A in the treatment of tinnitus.

Tinnitus Retraining Therapies:

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 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. 

Considerable literature is published on the theoretical basis behind TRT. In a systematic MEDLINE search of the English language literature conducted through July 2006, a limited number of articles were found which describe the favorable use of this therapy in the treatment of tinnitus. Since tinnitus is a subjective symptom without a known physiologic cause, randomized placebo-controlled trials are particularly important to validate the effectiveness of any treatment in comparison to an expected placebo effect.  

Bartnik et al (2001) described a study of 108 patients from a registry group of 516 patients with tinnitus and/or hyperacusis. The patients were divided into two groups: Sixty-eight cases with tinnitus only and 40 patients with tinnitus and hearing loss. The cases were provided differing therapies.  38 patients with tinnitus only, were provided counseling only 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 and the remaining 2 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 80% of the tinnitus only patients provided only counseling reported significant improvement and 73% of tinnitus only patients receiving counseling and noise generators for “near masking” reported improvement. In the second group with both tinnitus and hearing loss, 87% of 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 was not randomized, and it is not revealed how the subset of 108 patients was recruited for inclusion in the study.

Kroner-Herwig (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 therapy (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 cognitive therapy 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 size of this study, the use of a “waiting list” assigned group as a non-treatment control group has been criticized.  

Herraiz et al (2005) recently reported their results of a prospective, but non-randomized study of 158 patients referred to their clinic in Spain from January 2000 through December 2002. Visual analogue scale (VAS) for intensity and the Tinnitus Handicap Inventory (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, although larger, again used patients on a “wait list” as a control group.  In addition, this study was not randomized and the selection criteria for entry are not reported for a heterogeneous group of specialty referred patients.

An assessment by the Washington Department of Labor and Industries Office (2004) concluded that “due to lack of prospective trials with comparison groups, the efficacy of TRT for subjective tinnitus has not been established”(Wang 2004). Since there is insufficient credible evidence in the scientific literature from randomized controlled studies, the treatment of tinnitus with Tinnitus Retraining Therapies is considered investigational/not medically necessary. 

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 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 patient’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.

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. Data from the American Tinnitus Association points to a prevalence of tinnitus in 50 million Americans or about 20% (ATA, 2001). 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 toxicity (antimicrobials/chemotherapies), sudden deafness and Ménierè’s disease. Environmental factors include acute acoustic trauma, exposure to occupational noise, and overly amplified music.

Treatment is supportive in nature; there is no cure. Multiple medical therapies including lidocaine, antidepressants, anticonvulsants, anxiolytics, antihistamines, herbs, vitamins and minerals have been tried.  Others treatments have 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 based on the observation the electrical stimulation of the cochlea associated with a cochlear implant may be associated with a reduction in tinnitus. Transmeatal low-power laser irradiation and electromagnetic energy have also been evaluated. More recently, preliminary studies have looked at the impact of transcranial magnetic stimulation and subcutaneous injections of botulium toxin A on 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 (Briner, 1995). 

Tinnitus retraining, 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.  Maskers set at a level such that the tinnitus can still be detected are used to induce habituation.

Tinnitus:  a sensation of noise (as a ringing or roaring) caused by a bodily condition (as a disturbance of the auditory nerve or wax in the ear) and can usually be heard only by the one affected

The following codes for treatments and procedures applicable to this policy 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/Not Medically Necessary:

CPT

HCPCS

ICD-9 Diagnosis

Peer Reviewed Publications:

1. Anderson G, et al, Internet-based cognitive behavioral therapy for tinnitus, Journal of Clinical Psychology 2004; 60(2):171-8.
2. 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):206-8. 
3. Briner W. A behavioral nosology for tinnitus. Psychological Reports 1995 77(1):27-34.
4. Dobie RA, Hoberg KE, Rees TS. Electrical tinnitus suppression: a double-blind crossover study. Otolaryngol Head Neck Surg 1986; 95(3 pt 1):319-23.
5. 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.
6. Ghossaini S, Spitzer J, Mackins C, et al. High-frequency pulsed electromagnetic energy in tinnitus treatment. Laryngoscope 2004; 114(3):495-500.
7. Goebel G, Hiller W. The tinnitus questionnaire (TQ)-a standardized instrument for grading the severity of tinnitus:  results of a multicenter study using the TQ.  HNO 1994; 42: 166-72.
8. Herraiz, Carlos, et al, Long-term clinical trial of tinnitus retraining therapy. Otolaryngology Head and Neck surgery 2005 133, 774-9.
9. Jastreboff PJ, Hazell JW. A neurophysiological approach to tinnitus: clinical implications. Br J Audiol 1993; 27(1):7-17.
10. Jastreboff PJ et al. Tinnitus retraining therapy for patients with tinnitus and decreased sound tolerance. Otolaryngol Clin North Am 2003; 36(2): 321-36.
11. Jastreboff PJ, Jastreboff, MM, Tinnitus retraining therapy: a different view on tinnitus, ORL 2006;68: 23-30.
12. Kleinjung T, Eichhamer P, Langguth B et al. Long term effects of repetitive transcranial magnetic stimulation (rTMS) in patients with chronic tinnitus. Otolaryngology Head and Neck Surgery 2005: 132(4): 566-9.
13. Kroener-Herwig B, Biesinger E, Gerhards F et al. Retraining therapy for chronic tinnitus. A critical analysis of its status. Scand Audiol 2000; 29(2):67-78.
14. 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):381-9.
15. Nakashima T, Ueda H, Misawa H et al. Transmeatal low-power laser irradiation for tinnitus. Otol Neurotol 2002; 23(3):296-300.
16. Newman C, et al, Development of the tinnitus handicap inventory, arch Otolaryngol Head Neck Surg 1996; 122:143-48.
17. Schleuning AJ, Johnson RM, Vernon JA. Evaluation of a tinnitus masking program: a follow-up study of 598 patients. Ear Hear 1980; 1(2):71-4.
18. Steenerson RL, Cronin GW. Treatment of tinnitus with electrical stimulation. Otolaryngol Head Neck Surg 1999; 121(5):511-3.
19. Stephens SDG, Corcoran AL. A controlled study of tinnitus masking. Br J Audiol 1985; 19(2):159-67.
20. Stidham KR, Solomon PH, Roberson JB. Evaluation of botulinum toxin A in the treatment of tinnitus, Otolaryngol Head and Neck Surg 2005; 132(6):883-9.
21. 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.
22. Thedinger BS, Karlsen E, Schack SH. Treatment of tinnitus with electrical stimulation: an evaluation of the Audimax Theraband. Laryngoscope 1987; 97(1):33-7.
23. Wang G. Tinnitus retraining therapy. Health Technology assessment. Olympia WA: Washington State Department of Labor and Industries, Office of the Medical Director; June 7, 2004.
24. Wilson PH, Henry JL, Andersson G et al. A critical analysis of directive counseling as a component of tinnitus retraining therapy. Br J Audiol 1998; 32(5):273-86.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Centers for Medicare and Medicaid Services. National Coverage Determination for Computerized Tomography. NCD #220.1. Effective November 22, 1985. Available at:  http://www.cms.hhs.gov. Accessed on July 24, 2006.
2. Centers for Medicare and Medicaid Services. National Coverage Determination for Tinnitus Masking. NCD #50.6. Effective date not posted. Available at:  http://www.cms.hhs.gov. Accessed on July 24, 2006.

1. American Tinnitus Association (ATA) American Tinnitus Association: Committed to a Cure. Frequently Asked Questions.  Available at:  http://www.ata.org/about_tinnitus/consumer/faq.html#2. Accessed on: July 24, 2006.
2. National Institute on Deafness and Other Communication Disorders.  The Noise in Your Ears: Facts About Tinnitus.  Available at:      http://www.nidcd.nih.gov/health/hearing/noiseinear.asp  Accessed on: July 24, 2006.

Electrical Stimulation

Retraining

Tinnitus

Federal and State law, as well as contract language, including definitions and specific contract provisions/exclusions, take precedence over Medical Policy and must be considered first in determining eligibility for coverage. The member's contract benefits in effect on the date that services are rendered must be used. Medical Policy, which addresses medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Medical Policy periodically. No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by an means, electronic, mechanical, photocopying, or otherwise, without permission from the health plan.

©CPT Only - American Medical Association