Tinnitus treatment: clinical protocols
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Habituation theory has remained largely theoretical, although tinnitus treatment approaches such as relaxation therapy, attention diversion techniques directing attention away from tinnitus , and stress reduction by means of cognitive restructuring methods aimed at altering beliefs about the tinnitus have been based on its main premises.
To treat tinnitus distress or facilitate habituation to tinnitus , it was recommended that stress and arousal levels be reduced and to try and change the meaning of the tinnitus signal for the patient [ 28 ]. Research to date has yielded mixed evidence for the validity of habituation theory [ 7 ]. Evidence exists that cognitive processes, such as interpretation, attention, and memory, are indeed involved in chronic tinnitus suffering [ 5 , 16 , 60 , 65 , 72 ], and the validity of the cognitive model is currently being tested psychometrically [ 30 ].
The fear-avoidance model of tinnitus based on the fear-avoidance model of chronic pain [ 74 ]. These models differ in explaining how classic and operant learning principles contribute to tinnitus suffering. Both models place less importance on the behavioural processes. The fear avoidance model, which is based on associative learning principles, offers both explanatory predictions about cognitive processes of change and predictions about behavioural mechanisms.
Empirical data support the fear-avoidance model. However, the cause—effect relationships of specific learning mechanisms are still unknown [ 11 , 22 , 32 , 41 ]. Consensus on clinically relevant patient profiles, standard treatment, assessment, and referral trajectories has not been reached thus far. Even though chronic tinnitus complaints represent enormous socioeconomic relevance [ 13 , 80 , 81 , 82 ], research funding is still limited. The purpose of this chapter is to describe the methods used to develop this guideline.
This guideline consists of five chapters containing several modules. Some or all these modules may need revision or extension in the future.
The responsibility to maintain the guideline, for reassessment purposes and possible future revisions or extensions, lies with Drs. Rilana Cima and Derek Hoare. The group consists of representatives of all specialties and fields thought to be stakeholders in the clinical practice of tinnitus health care across Europe. All steering group members are responsible for the integral text of this guideline. In spite of increasing knowledge about its management and treatment, little impact on clinical practice has been observed.
There is evidence that prolonged, obscure and indirect referral trajectories persist in usual tinnitus care. It is widely acknowledged that efforts to change professional practice are more successful if barriers are identified and implementation activities are systematically tailored to the specific determinants of practice.
The first step towards the development of meaningful and actionable European guidelines for the assessment and treatment of tinnitus patients involved scoping the existence and current knowledge of standards in tinnitus care. Lack of time or other resources for professionals responsible for tinnitus patients to be able to adequately assess the distress level of tinnitus patients. High variation in available treatment options; more medical—pharmacological treatment in southern and eastern countries.
Counselling—rehabilitative approaches more available in northern countries. When many treatment avenues are seen as viable, it may be difficult to reach consensus on what works for whom. The use of self-report instruments is much less common in southern and eastern countries. There are differences in how patients pay for treatment. Consensus across regions on what conditions are relevant to or associated with tinnitus.
Although some minor differences in procedures were reported, most experts agree that otoscopy and pure tone audiometry are used. This finding facilitates discussions on diagnostics to include in the guidelines. The most commonly used questionnaire irrespective of region is the Tinnitus Handicap Inventory. The percentage of respondents satisfied with current tinnitus health care in their country in southern and eastern Europe was low; less than half of respondents reported they were satisfied. Health-care professionals are likely to be positive towards progressive guidelines and towards changes in health care for tinnitus.
The tinnitus assessments diagnostics and measures , processes and treatment options recommended by the respective guidelines were compared and summarised. Guidelines were considered eligible for inclusion if they fit the definition, and no publication date or language restrictions were imposed. In addition to these, the National Guideline Clearinghouse www. International experts were also contacted to ask if they were aware of any guidelines that had not already been identified from the search results.
Two reviewers independently screened each search result. The absence of guidelines for most countries contributes to the explanation for the variations that exist in assessment and treatment of tinnitus internationally. Across guidelines, differences in recommended assessment procedures tend to relate to specific techniques, questionnaires, diagnostic tests, or types of scanning techniques rather than to the assessment of tinnitus severity, hearing loss, psycho-social problem s , and the presence of severe physical pathology causing the tinnitus.
Results from the survey and the systematic review of guidelines were used to select and evaluate the modules included in Chap. Summary of recommendations regarding the assessment of subjective tinnitus. Summary of therapeutic recommendations regarding the treatment of subjective tinnitus. Most or all individuals will be best served by the recommended course of action. Level 1a, 1b, or 2a evidence that the desirable effects of an intervention outweigh its undesirable effects.
Initial drafts of this guideline were subjected to review in two consultation rounds. The comments from each round were aggregated and addressed across three consensus meetings of the steering group held in July and November , and in January Contributors in both consultation rounds were invited to comment on consecutive drafts of the guideline.
Contributors received feedback on all comments. The feedback included whether the change was made or not. In the second consultation round, an additional 25 outside-TINNET contributors submitted comments on the second draft. All contributors were asked to indicate if they did not want their details to be included in the contributor list of the final version of the guideline. The following sections outline recommended progressive levels of diagnostics and assessment of tinnitus.
The content and structure of these sections were informed by multiple sources in two steps. An initial proposal was thereafter agreed by consensus of the authors based on knowledge of current use in clinical practice specifically for tinnitus, and therefore of the need to provide endorsement of those procedures considered safe and clinically useful and exclude those that were considered not. This section was heavily revised according to comments received in both rounds of expert consultation.
To exclude treatable medical conditions, e. There are causal diagnostics and severity-oriented diagnostics. Modulation: Can the tinnitus percept be modulated by: orofacial, cervical or eye movements, head positions, movements of the jaw, tension of jaw muscles, physical exertions? Furthermore, the level of tinnitus awareness is of importance: Can tinnitus be perceived only in silence or also in noise; is the tinnitus easily masked or amplified by ordinary background noise; are there changes in tinnitus loudness?
Medical history: ear, nose and throat, orthopaedic, cervical, dental, jaw, internal medicine thyroid, hypertension, anaemia , mental disorders psychological, psychiatric. Complete ear, nose, and throat examination, especially otoscopy preferably micro-otoscopy to exclude presence of wax, tympanic membrane rupture, otitis media with effusion, chronic otitis media, retro-tympanic mass or any other pathology.
Special consideration should be given in rare tinnitus causes e. High-frequency audiometry in cases of tinnitus with normal hearing at standard conversational frequencies. Further sound tolerance assessment e. Caloric testing, and vestibular evoked myogenic potential, as indicated in cases of dizziness, vertigo, or balance problems. MRI of the brain in abnormal auditory brainstem response or abnormal vestibular evoked myogenic potential. Since distress refers to the general aversive state, instruments to measure this construct usually include sub-domains which are hypothesised to contribute to tinnitus severity.
There are several instruments in use for assessing level of severity of tinnitus complaints. It has three subscales; functional, emotional, and catastrophic responses to the tinnitus. Both the overall questionnaire and the functional and emotional subscales show good internal consistency. The Tinnitus Questionnaire TQ; [ 88 ] has six domains; emotional distress, cognitive distress, intrusiveness, auditory and perceptual difficulties, sleep disturbances, and somatic complaints because of the tinnitus. The TQ items are internally consistent; the subscales lack internal consistency, however.
It has four sub-scales: general distress, interference, severity, and avoidance of the tinnitus. Two items specifically measure how much tinnitus interferes with daily life activities. Seven items specifically address the interference of the tinnitus on daily activities; four of which address hearing difficulties, two items address social interactions and one item addresses sleep difficulties because of the tinnitus. The THQ subscales fail on internal consistency however. Additionally, almost all existing clinical practice guidelines [ 79 ] recommend using the Hospital Anxiety and Depression Scale [ 96 ] to assess negative affect coinciding with or reactionary to tinnitus.
Clinicians should educate patients with tinnitus about treatment strategies. For an extended presentation of the information that should be conveyed, see Chap. There is no evidence for the effectiveness of drug treatments specifically for tinnitus but evidence for potentially significant side effects. Recommendation is based on systematic reviews and randomised trials. It is common that treatment of acute tinnitus is given according to treatment of acute sudden hearing loss.
However, in both cases the evidence base for treatment is scarce [ 99 ]. Therefore, if tinnitus occurs acutely without hearing loss, the standard cortisone therapy is not recommended. Therapeutic approaches such as intratympanic steroid treatment have no effect on tinnitus [ ].
Any increase in tinnitus severity or distress in chronic tinnitus should not be treated as new-onset tinnitus. For chronic tinnitus, many classes of drugs have been used or trialled, including various anti-arrhythmics, anticonvulsants, anxiolytics, glutamate receptor antagonists, antidepressants, muscle relaxants, and others [ 45 ], with little evidence of benefit over harm [ ]. The Cochrane review of antidepressants for tinnitus [ ] identified six RCTs patients on the topic.
Only one study was judged to be of high quality. Side effects were commonly reported including sedation, sexual dysfunction, and dry mouth. Nonetheless, antidepressants are often successfully applied in the treatment accompanying depression and anxiety, not for improvement of the tinnitus. There were mixed results across studies and methodological issues which reduced confidence in the estimate of effect they reported. No drug can generally be recommended for the treatment of chronic tinnitus. However, psychiatric comorbidities associated with tinnitus anxiety, depression may need drug treatment.
Antidepressants should not be prescribed to tinnitus patients without the diagnosis of depression. Despite the relatively limited number of cochlear implant users, there are many studies of their effects on tinnitus. Of course, RCTs are not applicable in this context. Small case—control studies 3b have shown the efficacy of cochlear implantation in patients with unilateral deafness and persistent, bothersome tinnitus. Hence, larger studies are necessary to confirm these findings. Cochlear implantation is recommended only for patients meeting the hearing loss criteria for candidacy.
Recommendation for tinnitus based on evidence for safety but low-level evidence of effectiveness. Hearing loss is one of the most prevalent chronic diseases and causes of disability [ ]. The consequences of hearing loss in the overall health condition of the people suffering from it are significant. Although tinnitus has been strongly associated with hearing loss, the degree of hearing loss cannot linearly predict tinnitus severity. The significant benefit of hearing aids for hearing difficulties have been demonstrated in RCTs [ , , ]. It has also been suggested that hearing aids reduce tinnitus awareness, and thereby stress [ ], and reduce central auditory gain [ ] and homeostatic hyperactivity [ ], implicating them in tinnitus.
It has been hypothesised [ ] that increasing bandwidth the frequency range of sounds amplified may improve effectiveness. Combination hearing aids including amplification and sound generator in the same device are another option for patients who may benefit from both amplification and passive sound stimulation. Two subsequent RCTs compared hearing aids with combination hearing aids [ ] and conventional hearing aids with combination hearing aids or deep-fit hearing aids [ ] in patients with hearing loss and tinnitus.
Both trials concluded that all devices offered some equivalent benefit for tinnitus. Hesse [ ] included lower-level evidence studies in their systematic review but found study results to be contradictory and concluded that convincing prospective studies are required. Hearing aids are recommended for the management of hearing loss and should be considered as an option for patients with tinnitus and hearing loss. Recommendation is based on evidence of effectiveness and safety in RCTs of hearing aids for hearing loss and tinnitus, and systematic reviews considering hearing aids for tinnitus.
Hearing aids should not be offered to tinnitus patients without hearing loss. Neurostimulation treatments are hypothesised to alter tinnitus-generating neural firing. They can be invasive or non-invasive, and use electromagnetic, electrical, or sound stimuli. However, the precise neural mechanism by which changes occur at both local and network levels is not fully understood [ , ]. Moreover, with non-invasive treatments, the precise area of the brain to be stimulated is unknown.
Non-invasive treatments include transcranial electrical stimulation, vagus nerve stimulation transcutaneous , repetitive transcranial magnetic stimulation rTMS , and acoustic coordinated reset CR neuromodulation. Invasive treatments include vagus nerve stimulation implantable device , cortical surface stimulation, and deep brain stimulation.
Transcranial direct current stimulation tDCS delivers low-level direct current about 0. Thereby, some current is conducted through the scalp and some flows into the cerebral cortex where it is hypothesised to increase or decrease cortical excitability depending on the polarity in the brain regions where it is applied. It concluded that there was insufficient evidence to determine whether tDCS was effective for tinnitus. Many RCTs of tDCS have subsequently been conducted [ , , , , ], which report it to be safe but with little or no effect on tinnitus.
Transcranial alternating current stimulation tACS involves the delivery of alternating current constant polarity changes between electrodes placed on the skin over cortical regions of interest. It is hypothesised to affect up- and down-regulation of synapses, possibly affecting change in oscillatory cortical activity. There are few studies investigating tACS. One randomised study concluded there are no effects on tinnitus [ ]. There is evidence for safety but no evidence for the effectiveness of transcranial electrical stimulation for tinnitus.
Recommendation is based on systematic review and RCTs.
Evaluation and Treatment of Tinnitus: A Comparative Effectiveness Review
Experimental studies have examined the safety and efficacy of vagus nerve stimulation, both direct i. There is evidence for safety but insufficient evidence that vagus nerve stimulation treatments have effects on tinnitus. Recommendation is based on the lack of RCTs or systematic review. When used in treatment, the coil is placed next to the head over the target brain area.
It is hypothesised that the energy from the magnetic fields penetrates the skull to cause depolarisation of the superficial cortical neurons; rTMS for tinnitus has been studied extensively. However, high variability in study design and reported outcomes was noted and thus the review concluded the need for large-scale trials and replication studies.
Safety was not reported in this review. No consistent evidence that repetitive transcranial magnetic stimulation is effective for tinnitus and no evidence that it is safe in the long term. Recommendation is based on systematic reviews. It concluded that the available evidence indicates the treatment to be safe but that there is insufficient evidence of its effectiveness for clinical implementation of this treatment.
The review also concluded that the hypothesised mechanism of effect is unproven. Recommendation is based on systematic review. Invasive forms of tinnitus treatment are highly experimental and span vagus nerve stimulation with an implanted device, chronic electrical vestibulocochlear nerve stimulation, brain surface extradural implanted electrodes, and deep brain neural stimulator implantation. There are no RCTs or systematic reviews to date. There is no high-level evidence for the effectiveness or safety of invasive treatments for tinnitus.
Recommendation is based on lack of RCTs or systematic review. There is high-level evidence for the effectiveness and safety of CBT for tinnitus. Recommendation is based on systematic review and one further RCT. Cognitive behavioural therapy is an integrative and pragmatic therapy where the aim is to modify dysfunctional behaviours and beliefs to reduce symptoms, increase daily life functioning, and ultimately promote recovery from the disorder [ ].
Confusion often exists about the differences between cognitive therapy and CBT. Establishing the effectiveness of CBT in tinnitus health care and research is difficult because patients report to suffer in various life domains. In addition to general problems with daily functioning because of concentration difficulties and sleep deprivation, despair, depression, fear, and worry are amongst the most incapacitating. Disagreement still exists on what tinnitus-related domains and outcomes to measure, why, and how [ ], and in the research literature there is as of yet no standardisation of outcome selection.
Additionally, often the investigated tinnitus CBT approaches vary in number of treatment sessions, hours spent in therapy, group versus individual formats, face-to-face versus Internet- or book-based self-help therapies, combinations of different treatment elements, and tinnitus diagnostics and outcome assessments. This review will include more recent RCTs and comply with the latest Cochrane standards. These methodological issues make it harder to draw conclusions about the strength of any treatment effects and risks of bias in the evidence included in the narrative synthesis.
Stepped-care CBT4T has been implemented across several Dutch clinical centres as the cost-effective treatment option. Self-help CBT interventions Internet-based or otherwise appear efficacious in decreasing tinnitus distress when compared with passive control conditions, and less so when compared with active face-to-face CBT treatment [ ].
Additionally, treatment attrition in trials of self-help Internet-based or otherwise CBT interventions is high. There is evidence for safety but little high-level evidence for the effectiveness of TRT. Recommendation is based on availability of one RCT and two systematic reviews. One widely used treatment is tinnitus retraining therapy TRT , which is based on the neurophysiological model of tinnitus [ 37 ]. The principal goal of TRT is to achieve habituation of tinnitus through the retraining of the brain [ , ]. It means that owing to the high level of plasticity of the central nervous system, it is possible to reduce the responsiveness to repeated stimulation with neutral sound stimuli and trough the counselling [ ].
In this process, the limbic system and autonomic nervous system are the main systems responsible for negative tinnitus-evoked reactions, because those areas are activated when one stimulus is associated in the category of unpleasant or dangerous stimuli, which results in reactions of stress, anxiety, panic attack, or loss of well-being fight, flight, or freeze. Thus, the goal of TRT is to prevent tinnitus from activating the limbic system and automatic nervous system—habituation of reaction—and when the habituation of reaction is fully achieved, the patient does not experience negative tinnitus-evoked reaction.
After this, the cerebral cortex—habituation of perception—is automatically activated, because the brain habituates to all unimportant stimuli. If the patient achieves this habituation of perception, tinnitus is blocked before it reaches the consciousness level and the patient does not hear tinnitus [ ]. Categories of tinnitus retraining therapy for patients with tinnitus and hyperacusis. Full counselling with stress issues related to hyperacusis and sound therapy using sounds generators and hearing aids.
The Cochrane review of TRT [ ] found only one trial that met their inclusion criteria, concluding that the trial was of low quality and no final conclusions concerning the efficacy of TRT can be drawn. There is evidence for safety but little high-level evidence for the effectiveness of sound therapy. Acoustic stimulation may be the oldest approach aimed at improving tinnitus. This simple and intuitive approach has been and is still widely used. Importantly, this approach is not aimed at treating the causes of tinnitus but simply at helping to manage the consequences of tinnitus.
It is used in different ways. Other acoustic approaches have been developed to interfere with the tinnitus causes. For these methods, the assumptions relative to the tinnitus mechanisms are critical. All these methods assume that tinnitus results from central changes after hearing loss that can be reversed by appropriate acoustic stimulation. In general, acoustic stimulation has been shown to modestly improve tinnitus condition in several independent low-quality studies.
However, some changes resulting from sensory deprivation might be difficult to reverse, especially when sensory deprivation has been present for many years.
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It may not be possible to compensate fully for deprived inputs by means of acoustic stimulation. Many studies have shown that tinnitus masking therapy TMT can provide some relief for certain tinnitus subjects. Neuromonics treatment consists of an acoustic stimulation combining music and broadband noise [ , , ]. The spectrum of this combination is customised to provide an equalised stimulation over the audible frequency range.
In addition to providing stimulation within the deprived sensory region, the acoustic stimulation is also designed to promote relaxation and relief. These effects are reinforced and complemented by counselling.
This initial stage is also intended to maximise the amount of stimulation of the deprived sensory region. In an RCT by the manufacturers, this method was reported to significantly improve tinnitus. The study design included two groups with different modules of Neuromonics intervention, but participants self-adjusted the prescribed treatment for what they felt worked best, such that the intervention was no longer different between groups and their data were pooled.
Few independent studies of Neuromonics have been conducted. Of note, Newman and Sandridge [ ] compared the cost-effectiveness and cost utility of Neuromonics versus ear-level sound generators at about one third of the cost. Both interventions resulted in reduced tinnitus handicap score with no difference in improvement between groups. The notched music was intended to reduce tinnitus-related cortical activity within the notch, possibly through increasing lateral inhibition [ ]. It has been suggested that tinnitus may result from the central changes accompanying hearing loss [ ].
An implication of this model is that an appropriate acoustic stimulation may reverse the central changes due to hearing loss, including those involved in tinnitus generation. In this context, hearing aids may improve the tinnitus condition by restoring sensory inputs thereby reversing the tinnitus-related central changes due to hearing deprivation. Tinnitus severity estimated from the TFI, however, was not changed by the method. Sound therapy including masking, music, environmental sound may be useful for acute relief purposes but is not considered an effective intervention with long-term results.
There is evidence that dietary and alternative therapies e. Ginkgo biloba, melatonin, zinc, or other dietary supplements have no proven efficacy and pose potential harm in the management of tinnitus. Recommendation is based on RCTs and systematic reviews with methodological concerns. Ginkgo biloba is the most commonly used herbal supplement for tinnitus. Ginkgo biloba can interact with other blood thinners to cause serious bleeding and can worsen bleeding risk in patients with underlying clotting disorders [ ]. Although another study demonstrated potential benefit for patients with concomitant sleep disturbance due to tinnitus, this study lacked randomisation, blinding, or placebo control [ ].
Only one study reported possible adverse effects of melatonin, which included bad dreams and fatigue [ ]. It was suggested that benefit could be associated with underlying zinc deficiency. Evidence for the efficacy of these therapies for tinnitus does not exist [ ]. There is evidence for safety but little high-level evidence for the effectiveness of acupuncture. No recommendation can be made regarding the effect of acupuncture in patients with persistent bothersome tinnitus, based on poor-quality trials, no benefit, and minimal harm.
However, this systematic review highlighted the heterogeneity among study designs as well as their methodological limitations using the Cochrane tool for assessing risk of bias.
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Variations in study design included types of acupuncture intervention, frequency, intensity and duration of treatment sessions, selection of other control groups, variability with blinding, and selection of outcome measures, many of which were not validated [ ]. The authors concluded that the small number of RCTs of acupuncture for the treatment of tinnitus, with small sample size and methodological issues, were insufficient to make conclusions about effectiveness.
Criteria for assessment and treatment of tinnitus.
Nevertheless, evidence indicates the merits of audiological diagnostics, counselling, and education to decrease tinnitus suffering as well. On the basis of the current evidence, we suggest that the best tinnitus treatment strategy might be CBT based. It is essential to successful tinnitus treatment that patients are empowered to self-care, that they are provided with reliable information and learning resources, and that they are signposted to appropriate sources of support [ 34 ]. Patients need to understand tinnitus, how distressing tinnitus is managed, and what sources of information and support are available to them beyond their treatment sessions.
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