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DESCRIPTIONVarious non-pharmacological treatments are being evaluated to improve the subjective symptoms of tinnitus. These approaches include cognitive and behavioral therapies, coping therapies, use of tinnitus maskers, tinnitus-retraining therapy, customized sound therapy, transcranial magnetic stimulation, transcranial direct current stimulation, electrical stimulation of the ear, transmeatal laser irradiation, electromagnetic energy, and botulinum toxin A injections.
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 (eg, 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, as 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.
Sound therapy is a treatment approach that is based on evidence of auditory cortex reorganization (cortical re-mapping) with tinnitus, hearing loss, and sound/frequency training. One type of sound therapy uses an ear-worn device (Neuromonics® Tinnitus Treatment, Neuromonics, Australia) pre-recorded with selected relaxation audio and other sounds spectrally adapted to the individual patient’s hearing thresholds. This is achieved by boosting the amplitude of those frequencies where an audiogram has shown the patient to have a reduced hearing threshold. 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. 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.
Electrical stimulation to the external ear has also been investigated and is based on the observation that 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.
The Neuromonics® Tinnitus Treatment is one of many Tinnitus Maskers that has been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. It 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.”
Treatment of tinnitus with tinnitus coping therapy, tinnitus maskers, tinnitus retraining therapy, customized sound therapy, transcranial magnetic stimulation, transcranial direct current stimulation, electrical stimulation of the ear, transmeatal laser irradiation, electromagnetic energy, and botulinum toxin type A injections is considered investigational.
Note: This policy does not address surgical (eg, cochlear or brainstem implants) or pharmacologic treatment of tinnitus (e.g, use of amitriptyline or other tricyclic antidepressants).
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY11/2001: Approved by Medical Policy Advisory Committee (MPAC)
2/13/2002: Investigational definition added
5/8/2002: Type of Service and Place of Service deleted
11/3/2004: Code Reference section completed
9/6/2006: Policy reviewed, policy section clarified
9/13/2006: Policy updated. Updates approved per Medical Policy Advisory Committee (MPAC), ICD9 diagnosis code 388.3 deleted from policy
4/27/2009: Policy reviewed, no changes
05/28/2010: Policy description updated regarding treatment approaches. For clarity purposes, the policy statement was updated to add tinnitus coping therapy, transcutaneous electrical stimulation, and sound therapy as investigational treatment approaches. Intent of policy statement unchanged. FEP verbiage added to the Policy Exceptions section.
07/29/2011: Policy reviewed; no changes.
07/17/2012: Policy reviewed; no changes.
08/14/2013: Policy reviewed; no changes.
07/14/2014: Policy reviewed; description updated regarding devices. Policy statement unchanged.
08/27/2015: Code Reference section updated to add ICD-10 codes. Removed ICD-9 procedure code 18.9.
10/16/2015: Policy description updated regarding sound therapy. Policy statement unchanged. Investigative definition updated in the policy guidelines section.
04/21/2016: Policy description updated regarding non-pharmacological treatments. Policy statement updated to change "sound therapy" to "customized sound therapy" and to add transcranial direct current stimulation as investigational. Note in policy section updated to add that the policy does not address surgical (eg, cochlear or brainstem implants) treatment of tinnitus.
05/26/2016: Policy number added.
SOURCE(S)Blue Cross Blue Shield Association policy # 8.01.39
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.