Latest Review Date: March 2024

Category: Medical                                                                  

POLICY:

Treatment of tinnitus is considered investigational for all indications, including but not limited to the following situations:

• Tinnitus coping therapy
• Tinnitus maskers
• Tinnitus-retraining therapy (combined psychological and sound therapy)
• Customized sound therapy
• Transcranial magnetic stimulation
• Transcranial direct current stimulation
• Electrical transcutaneous stimulation of the ear
• Transmeatal laser irradiation
• Electromagnetic energy
• Botulinum toxin Type A injections
• Biofeedback (contract exclusion)
• Cognitive-behavioral therapy
• Self-help cognitive-behavioral therapy
• Acceptance and Commitment therapy
• Ozone therapy

NOTE: This policy does not address surgical (e.g., cochlear or brainstem implants) or pharmacologic treatment of tinnitus (e.g., the use of amitriptyline or other tricyclic antidepressants).

DESCRIPTION OF PROCEDURE OR SERVICE:

Various nonpharmacologic treatments are being evaluated to improve the symptoms of tinnitus. These approaches include psychological coping therapies, sound therapies, combined psychological and sound therapies, repetitive transcranial magnetic stimulation, electrical and electromagnetic stimulation, and transmeatal laser irradiation.

Tinnitus

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 types. The latter describes the minority of cases, in which an external stimulus is potentially heard by an observer (e.g., 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. The more common type is subjective tinnitus, which is frequently self-limited. In a small subset of patients with subjective tinnitus, its intensity and persistence leads to disruption of daily life. While many patients habituate to tinnitus, others may seek medical care if the tinnitus becomes too disruptive.

Many treatments are supportive in nature because, currently, 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. Psychological therapies may also be provided to improve coping skills, typically requiring 4 to 6 one-hour visits over an 18-month period. Tinnitus retraining therapy, also referred to as tinnitus habituation therapy, is based on the theories of Jastreboff, who proposed that tinnitus itself is related to the normal background electrical activity in auditory nerve cells, but the key factor in some patients’ unpleasant response to the noise is due to a spreading of the signal and an abnormal conditioned reflex in the extra-auditory limbic and autonomic nervous systems. The goal of tinnitus retraining therapy is to habituate (retrain) 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 is set at a level such that the tinnitus can still be detected. This strategy is thought to enhance extinction of the subconscious conditioned reflexes connecting the auditory system with the limbic and autonomic nervous systems by increasing neuronal activity within the auditory system. Treatment may also include the use of hearing aids to increase external auditory stimulation. The Heidelberg model uses an intensive program of active and receptive music therapy, relaxation with habituation to the tinnitus sound, and stress mapping with a therapist.

Sound therapy is a treatment approach based on evidence of auditory cortex reorganization (cortical remapping) with tinnitus, hearing loss, and sound/frequency training. One type of sound therapy uses an ear-worn device (Neuromonics Tinnitus Treatment; Neuromonics, Australia) prerecorded 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 at which an audiogram has shown the patient to have a reduced hearing threshold. Also being evaluated is auditory tone discrimination training at or around the tinnitus frequency. Another type of sound therapy that is being investigated uses music with the frequency of the tinnitus removed (notched music) to promote reorganization of sound processing in the auditory cortex. One theory behind notched music is that tinnitus is triggered by injury to inner ear hair cell population, resulting in both a loss of excitatory stimulation of the represented auditory cortex and loss of inhibition on the adjoining frequency areas. It is proposed that this loss of inhibition leads to hyperactivity and overrepresentation at the edge of the damaged frequency areas and that removing the frequencies overrepresented at the audiometric edge will result in reorganization of the brain.

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, electrical stimulation, and transcranial magnetic stimulation have also been evaluated.

KEY POINTS:

The most recent literature review was updated through January 2, 2024.

Summary of Evidence:

For individuals who have persistent, bothersome tinnitus who receive psychological coping therapy, the evidence includes randomized controlled trials (RCTs) and meta-analyses of RCTs. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. These therapies are intended to reduce tinnitus impairment and improve health-related quality of life. Meta-analyses of a variety of cognitive and behavioral therapies have found improvement in global tinnitus severity and quality of life, even when tinnitus loudness is not affected. Other RCTs have reported that a self-help/Internet-based approach to cognitive and behavioral therapy or acceptance and commitment therapy may also improve coping skills. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have tinnitus who receive sound therapy, the evidence includes RCTs and a systematic review of RCTs. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. The evidence on tinnitus masking includes RCTs and a systematic review of RCTs. The RCTs have medium-to-high risk of bias and did not show efficacy of masking therapy. Research on customized sound therapy appears to be at an early stage. For example, the studies described use of very different approaches for sound therapy, and it is not yet clear whether therapy is more effective when the training frequency is the same or adjacent to the tinnitus pitch. A 2016 trial, double-blinded and adequately powered, found no benefit of notched music on the primary outcome measures of tinnitus perception and tinnitus distress, although the subcomponent score of tinnitus loudness was reported to be reduced. Two more recent RCTs evaluating notched music therapy for tinnitus found no significant differences in efficacy between this approach and ordinary music therapy or counseling. One additional RCT found tailor-made notched music therapy and tinnitus retraining therapy both improved tinnitus handicap inventory (THI) and visual analog scale (VAS) scores from baseline to 3 months follow-up, but the notched music therapy group had significantly improved THI scores at 1-month follow-up and VAS scores at 3 months follow-up compared to tinnitus retraining therapy. A benefit on tinnitus loudness but not tinnitus perception or tinnitus distress is of uncertain clinical significance, may be spurious, and would need corroboration in additional studies. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have tinnitus who receive combined psychological and sound therapy (e.g., tinnitus retraining therapy), the evidence includes RCTs. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. The evidence on tinnitus retraining therapy consists of a number of small randomized or quasi-randomized controlled trials. Together, the literature does not show a consistent improvement in the primary outcome measure (THI or Tinnitus questionnaire scores) when tinnitus retraining therapy is compared with active or sham controls. For Heidelberg neuromusic therapy, one trial has used an investigator-blinded RCT design and showed positive short-term results following treatment. However, the durability of treatment is also unknown. A large, multicenter RCT trial using an intensive, multidisciplinary intervention showed improvement in outcomes. However, it is uncertain whether the multiple intensive interventions used in this trial could be replicated outside of the investigational setting. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have tinnitus who receive transcranial magnetic stimulation, the evidence includes a number of small- to moderate-sized RCTs and systematic reviews. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Results from these studies are mixed, with some trials reporting a statistically significant effect of repetitive transcranial magnetic stimulation on tinnitus severity and others reporting no significant difference. Larger controlled trials with longer follow-up are needed for this common condition. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have tinnitus who receive electrical or electromagnetic stimulation, the evidence includes a number of sham-controlled RCTs. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. The available evidence does not currently support use of these treatments. A 2015 sham-controlled study that was adequately powered found no benefit of transcranial direct current stimulation (tDCS). Moreover, while a 2017 meta-analysis found some benefit for transcranial direct current stimulation, it was noted that further study would be needed to evaluate transcranial direct current stimulation as a treatment option. Studies have not shown a benefit for direct current electrical stimulation of the ear. The evidence on electromagnetic energy includes a small RCT, which found no benefit for the treatment of tinnitus. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have tinnitus who receive transmeatal laser irradiation, the evidence includes RCTs and crossover trials. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. The evidence for transmeatal laser irradiation includes a number of double-blind RCTs, most of which showed no efficacy of this treatment. The evidence is insufficient to determine the effects of the technology on health outcomes.

Practice Guidelines and Position Statements:

American Academy of Otolaryngology-Head and Neck Surgeons

In 2014 the American Academy of Otolaryngology-Head and Neck Surgeons published evidence-based guidelines on Tinnitus. Table 1 provides some of the Academy’s recommendations.

Table 1. Guidelines on Treatment of Tinnitus

GOE: grade of evidence; SOR: strength of recommendation.

U.S. Preventative Services Task Force Recommendations

Not applicable.

KEY WORDS:

Tinnitus, tinnitus maskers, electrical stimulation, transmeatal laser irradiation, electromagnetic energy, tinnitus-retraining therapy, tinnitus coping therapy, transcranial magnetic stimulation, transcutaneous electrical stimulation, sound therapy, or botulinum toxin A injections masking device, sound therapy, treatment of tinnitus, Tinnitus Sound Generator Module, Audifon Tinnitus-Module, Tinnilogic Mobile Tinnitus Management De, Sound Options Tinnitus Treatment, Hypersound Tinnitus Module, Desyncra For Tinnitus Therapy System, De, Silentcloud™, Tinearity G1, Tinnitogram™ Signal Generator

APPROVED BY GOVERNING BODIES:

The Neuromonics® Tinnitus Treatment is one of many tinnitus maskers that has been cleared for marketing as a tinnitus masker through the U.S. 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”.

Table 2. Devices Cleared by the U.S. Food and Drug Administration

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP:  Special benefit consideration may apply.  Refer to member’s benefit plan. 

CURRENT CODING:

CPT Coding:

HCPCS Coding:

Tinnitus-masking devices represent a piece of durable medical equipment.  There is currently no specific HCPCS code describing these devices. 

REFERENCES:

1. Abtahi H, Okhovvat A, Heidari S, et al. Effect of transcranial direct current stimulation on short-term and long-term treatment of chronic tinnitus. Am J Otolaryngol. Mar - Apr 2018; 39(2):94-96.
2. Anders M, Dvorakova J, Rathova L et al. Efficacy of repetitive transcranial magnetic stimulation for the treatment of refractory chronic tinnitus: a randomized, placebo-controlled study. Neuro Endocrinol Lett 2010; 31(2):238-49.
3. Argstatter H, Grapp M, Hutter E, et al. The effectiveness of neuro-music therapy according to the Heidelberg model compared to a single session of educational counseling as treatment for tinnitus: a controlled trial. J Psychosom Res. Mar 2015; 78(3):285-292.
4. 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.
5. Bauer CA, Brozoski TJ. Effect of tinnitus retraining therapy on the loudness and annoyance of tinnitus: a controlled trial. Ear Hear. Mar-Apr 2011; 32(2):145-155.
6. Beukes EW, Baguley DM, Allen PM, et al. Audiologist-guided internet-based cognitive behavior therapy for adults with tinnitus in the United Kingdom: a randomized controlled trial. Ear Hear. Nov 1 2017.
7. Beukes EW, Andersson G, Allen PM, et al. Effectiveness of Guided Internet-Based Cognitive Behavioral Therapy vs Face-to-Face Clinical Care for Treatment of Tinnitus: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2018 Dec; 144(12).
8. Byun YJ, Lee JA, Nguyen SA, et al. Transcutaneous Electrical Nerve Stimulation for Treatment of Tinnitus: A Systematic Review and Meta-analysis. Otol Neurotol. Aug 2020; 41(7): e767-e775.
9. Cima RF, Maes IH, Joore MA et al.  Specialized treatment based on cognitive behavior therapy versus usual care for tinnitus: a randomized controlled trial. Lancet May 26 2012; 379 (9830): 1951-9.
10. Davis PB, Wilde RA, Steed LG et al. Treatment of tinnitus with a customized acoustic neural stimulus: a controlled clinical study. Ear Nose Throat J Jun 2008; 87(6):330-9.
11. Dehkordi MA, Einolghozati S, Ghasemi SM, et al. Effect of low-level laser therapy in the treatment of cochlear tinnitus: a double-blind, placebo-controlled study. Ear Nose Throat J. Jan 2015; 94(1):32-36.
12. Deklerck AN, Marechal C, Pérez Fernández AM, et al. Invasive Neuromodulation as a Treatment for Tinnitus: A Systematic Review. Neuromodulation. Jun 2020; 23(4): 451-462.
13. Dobie RA, Hoberg KE, Rees TS. Electrical tinnitus suppression: a double-blind crossover study. Otolaryngol Head Neck Surg Oct 1986; 95(3 Pt 1):319-23.
14. 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.
15. Folmer RL, Theodoroff SM, Casiana L, et al. Repetitive Transcranial Magnetic Stimulation Treatment for Chronic Tinnitus: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. Aug 2015; 141(8):716-722.
16. Fuller T, Cima R, Langguth B, et al. Cognitive behavioural therapy for tinnitus. Cochrane Database Syst Rev. Jan 08 2020; 1(1): CD012614.
17. Ghossaini SN, Spitzer JB, Mackins CC et al. High-frequency pulsed electromagnetic energy in tinnitus treatment. Laryngoscope Mar 2004; 114(3):495-500.
18. Grewal R, Spielmann PM, Jones SE, et al. Clinical efficacy of tinnitus retraining therapy and cognitive behavioural therapy in the treatment of subjective tinnitus: a systematic review. J Laryngol Otol. Dec 2014; 128(12):1028-1033.
19. Hall DA, Hibbert A, Smith H, et al. One Size Does Not Fit All: Developing Common Standards for Outcomes in Early-Phase Clinical Trials of Sound-, Psychology-, and Pharmacology-Based Interventions for Chronic Subjective Tinnitus in Adults. Trends Hear. 2019 Jan;23:2331216518824827
20. 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 Nov 2008; 117(11):791-9.
21. Henry JA, McMillan G, Dann S, et al. Tinnitus management: randomized controlled trial comparing extended-wear hearing aids, conventional hearing aids, and combination instruments. J Am Acad Audiol. Jun 2017; 28(6):546-561.
22. Henry JA, Schechter MA, Zaugg TL, et al. Clinical trial to compare tinnitus masking and tinnitus retraining therapy. Acta Otolaryngol Suppl. Dec 2006(556):64-69.
23. Herraiz C, Diges I, Cobo P et al. Auditory discrimination training for tinnitus treatment: the effect of different paradigms. Eur Arch Otorhinolaryngol Jul 2010; 267(7): 1067-74.
24. Hesser H, Gustafsson T, Lunden C et al. A randomized controlled trial of internet-delivered cognitive behavior therapy and acceptance and commitment therapy in the treatment of tinnitus. J Consult Clin Psychol 2012; 80(4): 649-61.
25. Hoare DJ, Kowallkowski VL, Kang S et al. Systematic review and meta-analysis of randomized controlled trials examining tinnitus management. Laryngoscope Jul 2011; 121(7):1555-64.
26. Hobson J, Chisholm E, El Refaie A. Sound therapy (masking) in the management of tinnitus in adults. Cochrane Database Syst Rev 2010; (12):CD006371.
27. Hoekstra CE, Versnel H, Neggers SF et al. Bilateral low-frequency repetitive transcranial magnetic stimulation of the auditory cortex in tinnitus patients is not effective: a randomised controlled trial. Audiol Neurootol 2013; 18(6):362-73.
28. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
29. Jacquemin L, Mertens G, Van de Heyning P, et al. Sensitivity to change and convergent validity of the Tinnitus Functional Index (TFI) and the Tinnitus Questionnaire (TQ): Clinical and research perspectives. Hear Res. Oct 2019; 382: 107796.
30. Jacquemin L, Shekhawat GS, Van de Heyning P, et al. Effects of Electrical Stimulation in Tinnitus Patients: Conventional Versus High-Definition tDCS. Neurorehabil Neural Repair. Aug 2018; 32(8):714-723.
31. Jalilvand H, Pourbakht A, Haghani H. Hearing aid or tinnitus masker: which one is the best treatment for blast-induced tinnitus? The results of a long-term study on 974 patients. Audiol Neurootol. 2015; 20(3):195-201.
32. Jasper K, Weise C, Conrad I, et al. Internet-based guided self-help versus group cognitive behavioral therapy for chronic tinnitus: a randomized controlled trial. Psychother Psychosom. 2014; 83(4):234-246.
33. Jastreboff PJ, Hazell JW. A neurophysiological approach to tinnitus: clinical implications. Br J Audiol 1993; 27(1):7-17.
34. Kaldo V, Cars S, Rahnert M et al. Use of a self-help book with weekly therapist contact to reduce tinnitus distress: a randomized controlled trial. J Psychosom Res 2007; 63(2):195-202.
35. 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):348-59.
36. 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.
37. Kleinjung T, Steffens T, Sand P et al. Which tinnitus patients benefit from transcranial magnetic stimulation? Otolaryngol Head Neck Surg 2007; 137(4):589-95.
38. 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.
39. Landry EC, Sandoval XCR, Simeone CN et al. Systematic Review and Network Meta-analysis of Cognitive and/or Behavioral Therapies (CBT) for Tinnitus. Otol. Neurotol. 2020 Feb; 41(2): 153-166.
40. Langguth B, Landgrebe M, Frank E, et al. Efficacy of different protocols of transcranial magnetic stimulation for the treatment of tinnitus: Pooled analysis of two randomized controlled studies. World J Biol Psychiatry. May 2014; 15(4):276-285.
41. Lefaucheur JP, Antal A, Ayache SS, et al. Evidence-based guidelines on the therapeutic use of transcranial direct current stimulation (tDCS). Clin Neurophysiol. Jan 2017; 128(1):56-92.
42. Li SA, Bao L, Chrostowski M. Investigating the effects of a personalized, spectrally altered music-based sound therapy on treating tinnitus: a blinded, randomized controlled trial. Audiol Neurootol. Nov 12 2016; 21(5):296-304.
43. Marcondes RA, Sanchez TG, Kii MA et al. Repetitive transcranial magnetic stimulation improves tinnitus in normal hearing patients: a double-blind controlled, clinical and neuroimaging outcome study. Eur J Neurol 2009; 17(1):38-44.
44. Martinez Devesa P, Waddell A, Perera R et al. Cognitive behavioural therapy for tinnitus. Cochrane Database Syst Rev 2007 Jan 24; (1):CD005233.
45. Martinez-Devesa P, Perera R, Theodoulou M et al. Cognitive behavioural therapy for tinnitus. Cochrane Database Syst Rev 2010 Sep 8; (9):CD005233.
46. McKenna L, Marks EM, Vogt F. Mindfulness-Based Cognitive Therapy for Chronic Tinnitus: Evaluation of Benefits in a Large Sample of Patients Attending a Tinnitus Clinic. Ear Hear. Mar/Apr 2018; 39(2):359-366. 
47. Meng Z, Liu S, Zheng Y et al.  Repetitive transcranial magnetic stimulation for tinnitus.  Cochrane Database Syst Rev 2011; (10):CD007946. 
48. Mielczarek M, Olszewski J. Direct current stimulation of the ear in tinnitus treatment: a double-blind placebo-controlled study. Eur Arch Otorhinolaryngol. Jun 2014; 271(6):1815-1822.
49. Nakashima T, Ueda H, Misawa H et al. Transmeatal low-power laser irradiation for tinnitus. Otol Neurotol May 2002; 23(3):296-300.
50. Ngao CF, Tan TS, Narayanan P, et al. The effectiveness of transmeatal low-power laser stimulation in treating tinnitus. Eur Arch Otorhinolaryngol. May 2014; 271(5):975-980.
51. Okamoto H, Stracke H, Stoll W et al. Listening to tailor-made notched music reduces tinnitus loudness and tinnitus-related auditory cortex activity. Proc Natl Acad Sci U S A Jan 19 2010; 107(3):1207-10.
52. Pal N, Maire R, Stephan MA, et al. Transcranial Direct Current Stimulation for the Treatment of Chronic Tinnitus: A Randomized Controlled Study. Brain Stimul. Nov-Dec 2015; 8(6):1101-1107.
53. Peng Z, Chen XQ, Gong SS. Effectiveness of repetitive transcranial magnetic stimulation for chronic tinnitus: a systematic review. Otolaryngol Head Neck Surg 2012; 147(5): 817-25.
54. Phillips JS, McFerran D. Tinnitus Retraining Therapy (TRT) for tinnitus. Cochrane Database Syst Rev Mar 17 2010; 2010(3):CD007330.
55. Pichora-Fuller MK, Santaguida P, Hammill A et al. Evaluation and Treatment of Tinnitus: Comparative Effectiveness. (Comparative Effectiveness Review No. 122). Rockville, MD: Agency for Healthcare Research and Quality; August 2013. 
56. Piromchai P, Srisukhumchai C, Kasemsiri P, et al. A Three-arm, Single-blind, Randomized Controlled Trial Examining the Effects of Notched Music Therapy, Conventional Music Therapy, and Counseling on Tinnitus. Otol Neurotol. Feb 01 2021; 42(2): 335-340.
57. 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):238-46.
58. Rossi S, De Capua A, Ulivelli M et al. Effects of repetitive transcranial magnetic stimulation on chronic tinnitus: a randomized, crossover, double blind, placebo controlled study. J Neurol Neurosurg Psychiatry 2007; 78(8):857-63.
59. Scherer RW, Formby C. Effect of Tinnitus Retraining Therapy vs Standard of Care on Tinnitus-Related Quality of Life: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. Jul 01 2019; 145(7): 597-608.
60. 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.
61. Sereda M, Xia J, El Refaie A, et al. Sound therapy (using amplification devices and/or sound generators) for tinnitus. Cochrane Database Syst Rev. 2018 Dec 27;12(12):CD013094.
62. Soleimani R, Jalali MM, Hasandokht T. Therapeutic impact of repetitive transcranial magnetic stimulation (rTMS) on tinnitus: a systematic review and meta-analysis. Eur Arch Otorhinolaryngol. Jul 2016; 273(7): 1663-75.
63. Song JJ, Vanneste S, Van de Heyning P et al. Transcranial direct current stimulation in tinnitus patients: a systemic review and meta-analysis. ScientificWorldJournal 2012; 2012: 427941.
64. Steenerson RL, Cronin GW. Treatment of tinnitus with electrical stimulation. Otolaryngol Head Neck Surg 1999; 121(5):511-3.
65. Stein A, Wunderlich R, Lau P, et al. Clinical trial on tonal tinnitus with tailor-made notched music training. BMC Neurol. Mar 17 2016;16:38
66. Stephens SD, Corcoran AL. A controlled study of tinnitus masking. Br J Audiol 1985; 19(2):159-67.
67. Stidham KR, Solomon PH, Roberson JB. Evaluation of botulinum toxin A in treatment of tinnitus. Otolaryngol Head Neck Surg 2005; 132(6):883-9.
68. Tauber S, Schorn K, Beyer W et al. Transmeatal cochlear laser (TCL) treatment of cochlear dysfunction: a feasibility study for chronic tinnitus. Lasers Med Sci 2003; 18(3):154-61.
69. Teggi R, Bellini C, Piccioni LO et al. Transmeatal low-level laser therapy for chronic tinnitus with cochlear dysfunction. Audiol Neurootol 2009; 14(2):115-20.
70. Thedinger BS, Karlsen E, Schack SH. Treatment of tinnitus with electrical stimulation: an evaluation of the Audimax Theraband. Laryngoscope Jan 1987; 97(1):33-7.
71. Theodoroff SM, McMillan GP, Schmidt CJ, et al. Randomised controlled trial of interventions for bothersome tinnitus: Desyncra TM versus cognitive behavioural therapy. Int J Audiol. Dec 2022: 61(12): 1035-1044.
72. Therdphaothai J, Atipas S, Suvansit K, et al. A Randomized, Controlled Trial of Notched Music Therapy for Tinnitus Patients. J Int Adv Otol. May 2021; 17(3): 221-227.
73. Tong Z, Deng W, Huang X, et al. Efficacy of Tailor-Made Notched Music Training Versus Tinnitus Retraining Therapy in Adults With Chronic Subjective Tinnitus: A Randomized Controlled Clinical Trial. Ear Hear. Jul-Aug 2023; 44(4): 670-681.
74. Tunkel DE, Bauer CA, Sun GH, et al. Clinical practice guideline: tinnitus. Otolaryngol Head Neck Surg 2014; Oct; 151(2Suppl):S1-S40.
75. Wang TC, Tyler RS, Chang TY, et al. Effect of transcranial direct current stimulation in patients with tinnitus: a meta-analysis and systematic review. Ann Otol Rhinol Laryngol. Feb 2018; 127(2):79-88.
76. Weise C, Kleinstauber M, Andersson G. Internet-delivered cognitive-behavior therapy for tinnitus: a randomized controlled trial. Psychosom Med. May 2016; 78(4):501-510.
77. Westin VZ, Schulin M, Hesser H et al.  Acceptance and commitment therapy versus tinnitus retraining therapy in the treatment of tinnitus:  a randomized controlled trial.  Behav Res Ther Nov 2011; 49(11):737-47.
78. 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.
79. Xing M, Kallogjeri D, Piccirillo JF. Investigating the Impact of Cognitive Training for Individuals With Bothersome Tinnitus: A Randomized Controlled Trial. Otolaryngol Head Neck Surg. Dec 2021; 165(6): 854-861.
80. Zenner HP, Vonthein R, Zenner B et al. Standardized tinnitus-specific individual cognitive-behavioral therapy: a controlled outcome study with 286 tinnitus patients. Hear Res 2013; 298:117-25.

POLICY HISTORY:

Medical Policy Panel, May 2011

Medical Policy Group, June 2011 (2): New policy

Medical Policy Administration Committee, September 2011

Available for comment September 22 through November 7, 2011

Medical Policy Panel, May 2012

Medical Policy Group, June 2012 (2): Updated policy to include low-level laser as a non-covered indication.  Key Points, Coding, and References updated

Medical Policy Administration Committee, June 2012

Available for comment June 14 through July 30, 2012

Medical Policy Panel, May 2013

Medical Policy Group, June 2013 (2): 2013 Updates to Description, Key Points, and References

Medical Policy Pane, June 2014

Medical Policy Group, June 2014 (5): 2014 Reworked and added updates to Key Points and References.

Medical Policy Panel, May 2015

Medical Policy Group, May 2015 (6):  Updates to Description, Key Points, Approved by Governing Bodies and References; no change to policy statement.

Medical Policy Panel, March 2016

Medical Policy Group, March 2016 (6):  Updates to Key Points, Policy statement clarification/reorganization, Approved by Governing Bodies, Coding and References; no change to policy intent.

Medical Policy Panel, February 2017

Medical Policy Group, March 2017 (6):  Updates to Description, Key Points, References; no change to policy statement.

Medical Policy Panel, February 2018

Medical Policy Group, March 2018 (6): Updates to Key Points, Practice Guidelines, Coding and References. Clarified policy statement.

Medical Policy Panel, February 2019

Medical Policy Group, April 2019 (6): Updates to Key Points, Governing Bodies, Key Words (Audifon Tinnitus-Module, Tinnilogic Mobile Tinnitus Management De, Sound Options Tinnitus Treatment, Hypersound Tinnitus Module, Desyncra For Tinnitus Therapy System, De) and References.

Medical Policy Group, December 2019 (6): 2020 Annual Coding update, 96152 deleted, added 96158.

Medical Policy Panel, February 2020

Medical Policy Group, February 2020 (6): Updates to Key Points, Coding (0552T) and References.

Medical Policy Panel, February 2021

Medical Policy Group, March 2021 (3): 2021 Updates to Key Points, and References. Policy statement updated to remove “not medically necessary, “no other changes to policy statement or intent.

Medical Policy Panel, February 2022

Medical Policy Group, February 2022 (3): 2022 Updates to Key Points, Practice Guidelines and Position Statements, Approved by Governing Bodies, and References. No change to policy statement.

Medical Policy Panel, February 2023

Medical Policy Group, February 2023 (6): Updates to Policy statement to expand non-covered therapies, Benefit Application and Key Points.

Medical Policy Group, May 2023 (6): Updated Policy statement to include non-covered therapy "ozone therapy".

Medical Policy Panel, February 2024

Medical Policy Group, March 2024 (9) Updates to Key Points, Key Words Silentcloud, Tinearity G1, Tinnitogram Signal Generator added, Approved by Governing Bodies, Benefit Application and References.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.