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Treatment of Tinnitus

Policy Number: MP-482

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

Recommendation

SOR

GOE

“Clinicians must differentiate patients with bothersome tinnitus from patients with non bothersome tinnitus”

Strong recommendation

B

“Clinicians should distinguish patients with bothersome tinnitus of recent onset from those with persistent symptoms (≥ 6 months) to prioritize intervention and facilitate discussion about natural history and follow-up care”

Recommendation

B

“Clinicians may recommend sound therapy to patients with persistent, bothersome tinnitus”

Option

C

“Clinicians should recommend cognitive behavioral therapy to patients with persistent, bothersome tinnitus”

Recommendation

A

“Clinicians should not routinely recommend antidepressants, anticonvulsants, anxiolytics, or intratympanic medications for a primary indication of treating persistent, bothersome tinnitus”

Recommendation against

B

“Clinicians should not recommend transcranial magnetic stimulation for the routine treatment of patients with persistent, bothersome tinnitus”

Recommendation against

 

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 Adminstration

Devices

Manufacturer

Date Cleared

510(k) No.

Indication

Tinearity G1 (6103); Tinearity G1 Adapters X3 (6042) Duearity AB 06/30/2023 K223694 Tinnitus Relief
Tinnitogram Signal Generator Goldenear Company, Inc 02/01/2023 K221168 Tinnitus Relief
Silentcloud Aureliym GmBH 01/04/2023 K221125 Tinnitus Relief

Multiflex Tinnitus Technology

Starkey Laboratories

6/19/2020

K201370

Tinnitus Relief

Tinnitus Sound Generator Module

Gn Hearing A/S

2/20/2020

K193303

Tinnitus Relief

Tinnitus Sound Generator Module

Gn Hearing A/S

11/30/2018

K180495

Tinnitus Relief

Audifon Tinnitus-Module

Audiofon Usa Inc.

10/19/2017

K171243

Tinnitus Relief

Tinnilogic Mobile Tinnitus Management De

Jiangsu Betterlife Medical Co., Ltd.

5/17/2017

K163094

Tinnitus Relief

Sound Options Tinnitus Treatment

Sound Options Tinnitus Treatments Inc.

9/28/2016

K161562

Tinnitus Relief

Hypersound Tinnitus Module

Turtle Beach Corporation

8/23/2016

K161331

Tinnitus Relief

Desyncra For Tinnitus Therapy System, De

Neurotherapies Reset Gmbh.

1/20/2016

K151558

Tinnitus Relief

Reve134

Kw Ear Lab, Inc

10/9/2015

K151719

Tinnitus Relief

Serenity

Sanuthera, Inc.

7/27/2015

K150014

Tinnitus Relief

Soundcure Serenade Tinnitus Treatment System

Soundcure, Inc.

4/13/2015

K150065

Tinnitus Relief

Levo Tinnitus Masking Software Device

Otoharmonics Corp

7/18/2014

K140845

Tinnitus Relief

Solace Sound Generators

Amplisound Hearing Products & Services

3/25/2014

K132965

Tinnitus Relief

Tinnitus Soundsupport

Oticon A/S

3/18/2014

K133308

Tinnitus Relief

Wave 2g, Soul

Hansaton Akustik Gmbh

1/3/2014

K130937

Tinnitus Relief

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:

90832-90838

Psychotherapy code range

92507

Treatment of speech, language, voice, communication, and/or auditory processing disorder; individual

92625

Assessment of tinnitus (includes pitch, loudness matching, and masking)

96158

Health behavior intervention, individual, face to face; initial 30 minutes

97014

Application of a modality to 1 or more areas; electrical stimulation (unattended)

97026

Application of a modality to 1 or more areas; infrared

0552T

Low-level laser therapy, dynamic thermokinetic energies, provided by a physician or other qualified health care professional

HCPCS Coding:

E0720

Transcutaneous electrical nerve stimulation (TENS) device, two-lead, localized stimulation

S8948

Application of a modality (requiring constant provider attendance) to one or more areas; low-level laser; each 15 minutes

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

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  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.
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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.