4.1 Available treatments and evidence

Informed knowledge

Clinicians should educate patients with tinnitus about treatment strategies. For an extended presentation of the information that should be conveyed, see Chap. 5.

Drug/pharmacological

Weak recommendation against 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. Present psychosomatic factors can play a decisive role [118]. Therapeutic approaches such as intratympanic steroid treatment have no effect on tinnitus [168]. Any increase in tinnitus severity or distress in chronic tinnitus should not be treated as new-onset tinnitus. This should be regarded and treated as a fluctuation of chronic tinnitus [119].

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 [169]. The Cochrane review of antidepressants for tinnitus [100] identified six RCTs (610 patients) on the topic. Only one study was judged to be of high quality. This study compared the effect of Paroxetine (a serotonin re-uptake inhibitor) with placebo, finding no significant difference in effect between groups. No effect was seen for trazadone (serotonin antagonist and reuptake inhibitor) and a small effect was seen for tricyclic antidepressants, but the reviewers concluded this could have been due to methodological issues in the studies. 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.

Jufas and Wood [131] provided a systematic review of benzodiazepines for tinnitus also finding six clinical trials which examined the use of diazepam, oxazepam, and clonazepam. There were mixed results across studies and methodological issues which reduced confidence in the estimate of effect they reported. Thus, they concluded that benzodiazepine use for subjective tinnitus does not have a robust evidence base and that these drugs must be used with caution because of serious side effects.

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.

Hearing loss interventions

Cochlear implants.

Despite the relatively limited number of cochlear implant users, there are many studies of their effects on tinnitus. In a systematic review of the effects of cochlear implantation on tinnitus in patients with bilateral hearing loss, five studies were found which reported on changes in tinnitus after implantation [157]. Based on tinnitus questionnaire scores, the review found total suppression of tinnitus in 30–37% of patients, a decrease in 29–72% of patients, no change in 0–30% of patients, and a worsening in 0–25% of patients across studies. 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.

No recommendation for (tinnitus); recommendation for (deafness) 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 aids.

Hearing loss is one of the most prevalent chronic diseases and causes of disability [176]. The consequences of hearing loss in the overall health condition of the people suffering from it are significant. It has been suggested that the reduced physical and mental activity and secondary social isolation caused by hearing loss [98] increase the risk of cognitive decline/dementia [138], mental illness [140] and depression [105, 140]. Although tinnitus has been strongly associated with hearing loss, the degree of hearing loss cannot linearly predict tinnitus severity. Only 50% of patients with hearing loss experience tinnitus including many patients who are profoundly deaf [133, 156]. In addition, 10% of tinnitus sufferers have normal pure tone audiometry [161, 162]. Furthermore, tinnitus occurs in different percentages in groups of patients with various causes of hearing loss ranging from 30% (in ototoxicity) to 90% (in acoustic trauma). The significant benefit of hearing aids for hearing difficulties have been demonstrated in RCTs [111, 128, 144].

It has also been suggested that hearing aids reduce tinnitus awareness, and thereby stress [109], and reduce central auditory gain [152] and homeostatic hyperactivity [177], implicating them in tinnitus. It has been hypothesised [109] 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. Yet there is minimal high-level evidence for the efficacy of hearing aids for tinnitus in systematic reviews; Hoare et al. [124] included just one RCT [151] which found hearing aids to be beneficial but equally effective to sound generators for tinnitus. Two subsequent RCTs compared hearing aids with combination hearing aids [116] and conventional hearing aids with combination hearing aids or deep-fit hearing aids [117] in patients with hearing loss and tinnitus. Both trials concluded that all devices offered some equivalent benefit for tinnitus. Hesse [119] included lower-level evidence studies in their systematic review but found study results to be contradictory and concluded that convincing prospective studies are required.

Weak recommendation for 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. Tinnitus might be a parameter to be considered in hearing aid fitting and consequent relevant decision-making.

Neurostimulation

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 [123, 158]. 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 electrical stimulation.

Transcranial direct current stimulation (tDCS) delivers low-level direct current (about 0.5–2 mA) via scalp electrodes to the cortex. 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 was first proposed as a treatment for tinnitus by Fregni et al. [112]. The most recent systematic review of tDCS included 17 studies but only two RCTs [166]. It concluded that there was insufficient evidence to determine whether tDCS was effective for tinnitus. The review called for further RCTs of tDCS and studies involving variations to the stimulation protocol. Many RCTs of tDCS have subsequently been conducted [101, 102, 149, 163, 172], 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 [172].

No recommendation 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.

Vagus nerve stimulation.

Stimulation of the vagus nerve is a means of stimulating the cholinergic nucleus basalis, which in turn has been shown to induce sustained changes in cortical organisation. By this mechanism, vagus nerve stimulation, paired with sound stimuli (to promote reorganisation in the auditory cortex), is a hypothesised treatment for tinnitus. Experimental studies have examined the safety and efficacy of vagus nerve stimulation, both direct (i. e. implanted electrode) and transcutaneous, paired with acoustic stimulation for tinnitus [108, 129, 134, 136, 178]. Tyler et al. [171] conducted a prospective randomised double-blind controlled pilot study of the effects of direct vagus nerve stimulation paired with tones on tinnitus. They reported high compliance, mild, well-tolerated adverse effects, but no significant between-group difference in tinnitus at the end of their 6‑week randomisation period.

No recommendation 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.

Repetitive transcranial magnetic stimulation.

Repetitive transcranial magnetic stimulation (rTMS) uses strong electric current generated within a coil to create fast-oscillating magnetic fields. 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. The most recent systematic review [165] included 15 studies and concluded on a significant effect of treatment. 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. A Cochrane review [143] included five RCTs and concluded that (1) there was limited support across studies that rTMS was beneficial, and (2) there was insufficient information to conclude it was safe in the long term.

Recommendation against 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.

Acoustic coordinated reset (CR®) neuromodulation.

Acoustic CR® neuromodulation is a sound therapy involving a randomised sequence of four “phase resetting” tones adjusted to the patient’s dominant tinnitus pitch that are hypothesised to generate a lasting desynchronisation of the pathological brain rhythms causing tinnitus. A systematic review of acoustic CR® neuromodulation included eight studies [175]. 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.

No recommendation Acoustic CR® neuromodulation is safe but there is no high-level evidence of effectiveness. Recommendation is based on systematic review.

Invasive neurostimulation treatments.

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. That they are invasive means they are not a viable option for widespread use. Research to date is limited to a small number of cases and in each the precise neural mechanism by which changes occur at both local and network levels is not fully understood (for a comprehensive review, see Hoare et al., [123]). There are no RCTs or systematic reviews to date.

No recommendation 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.

Cognitive behavioural therapy

Strong recommendation for 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 approaches share the premise that human suffering (psychological distress) and resulting problems are based in malfunctioning information processing, emotional reactivity, and behavioural mechanisms (see Appendix E for further general information on CBT). The CBT approaches have led to a plethora of evidence-based cognitive behavioural treatments for mental and somatic health disorders [127]. 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 [110]. Confusion often exists about the differences between cognitive therapy and CBT. Since CBT stems from the convergence of two distinct theoretical schools, the radical behavioural school (first wave) and the cognitive school (second wave), CBT entails a diversity of both cognitive and behavioural principles and methods, and usually a combination of these are used in therapeutic sessions. Therefore, both cognitive and behavioural treatment elements can be found when reviewing CBT procedures in general and thus in tinnitus intervention/treatment research as well.

Cognitive behavioural theory and treatment have been applied in tinnitus research for decades and the results of the effectiveness of CBT approaches for tinnitus have been shown to vary in decreasing tinnitus severity/distress, tinnitus-related fear, tinnitus disability, and tinnitus-related cognitive problems and in improving daily life functioning [13, 120, 126, 139, 141]. 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 [122], 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.

Since the most recent Cochrane review of CBT for tinnitus was published [139], a new Cochrane CBT review protocol has been published [22]. This review will include more recent RCTs and comply with the latest Cochrane standards.

The most recently published review of CBT interventions for tinnitus was a historical and narrative overview in which a range of study designs in addition to RCTs were included, but one in which neither a risk of bias assessment was undertaken, nor a meta-analysis conducted [84]. 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. Cognitive behavioural therapy for tinnitus (CBT4T) often includes a combination of several elements (such as education, counselling, exposure, mindfulness, relaxation, hearing rehabilitation). In a large RCT it was found that specialised CBT for tinnitus showed significant better group differences in improvement in quality of life (d = 0.24), decreasing severity of tinnitus (d = 0.43) and tinnitus disability (d = 0.45), as well as decreasing depressive and anxious symptoms, when compared with general audiological counselling and diagnostics only [13].

Despite the afore-mentioned limitations and the need to be cautious about the exact effectiveness of CBT for tinnitus in general, at present, a specialised stepped-care CBT4T [13] is the only available therapeutic health-care intervention for tinnitus supported by a high-quality clinical trial. Stepped-care CBT4T has been implemented across several Dutch clinical centres as the cost-effective treatment option. Additionally, stepped-care CBT4T is generally well received by patients and is potentially a cost-effective means for reducing the reactivity [80]. The treatment can be defined as a stepped-care Footnote 4multimodal CBT4T approach in which audiological diagnostics, treatment and consultation as well as CBT-treatment elements are combined.

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 [147]. Additionally, treatment attrition in trials of self-help (Internet-based or otherwise) CBT interventions is high. Nonetheless, CBT in a self-help format might be a useful alternative to support tinnitus patients who are unable or unwilling to take part in a face-to-face CBT treatment.

Where there are pragmatic barriers and/or lack of resources, an initial step of CBT treatment might be performed by a competent non-psychological professional provided there is appropriate support.

Tinnitus retraining therapy

No recommendation 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]. Tinnitus retraining therapy is a specific implementation of general tinnitus habituation therapy, which utilises directive counselling to decrease the negative tinnitus-evoked reactions and sound to decrease the strength of tinnitus signal [130]. The principal goal of TRT is to achieve habituation of tinnitus through the retraining of the brain [130, 164]. 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 [164]. 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). But, tinnitus without negative association leads to the extinction of a response to tinnitus. 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 [164].

Based on a medical evaluation of tinnitus, patients are placed into one of five general categories that guide the treatment recommended (Table 8). Each one of five categories is associated with a specific variant of TRT treatment, and all patients receive counselling and sound therapy, with substantial differences. Sound therapy has an important role in TRT. Specifically, sound therapy acts by providing the auditory systems with constant neutral signs with sound generators, hearing aids, or background noise. This decreases the contrast between tinnitus-related neural activity and background activity. Furthermore, the sound therapy interferes with the detection of tinnitus signal and decreases the gain within the auditory pathways [119, 135, 164].

Table 8 Categories of tinnitus retraining therapy for patients with tinnitus and hyperacusis Full size table

The Cochrane review of TRT [153] 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. The same single study was also included in a more recent systematic review of CBT and TRT, although in this review the study was rated as high quality [113].

Sound therapy

No recommendation There is evidence for safety but little high-level evidence for the effectiveness of sound therapy. Recommendation is based on RCTs and a systematic review.

Acoustic stimulation may be the oldest approach aimed at improving tinnitus. It is at least the most “natural” one, as tinnitus patients can experience every day that an external acoustic source can mask their 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. It is unclear whether acoustic stimulation might improve tinnitus through some interaction with tinnitus mechanisms, through the partial or complete masking of tinnitus, and/or through certain cognitive influences (diversion, stress management etc.). Tinnitus is a highly heterogeneous entity and acoustic stimulation may be very beneficial for some patients while completely ineffective for others. The “central” model of tinnitus assumes that the central changes due to sensory deprivation involved in tinnitus generation are reversible. However, some changes resulting from sensory deprivation might be difficult to reverse, especially when sensory deprivation has been present for many years. It may not be possible to compensate fully for deprived inputs by means of acoustic stimulation. Indeed, the cochlea (and/or cochlear nerve) can have nonfunctional areas, which are called “dead regions”. The presence of “dead regions” prevents any acoustic stimulation from activating the auditory centres within the corresponding projecting areas.

Tinnitus masking therapy.

Many studies have shown that tinnitus masking therapy (TMT) can provide some relief for certain tinnitus subjects. However, only a few of the studies included placebo controls [126] and the different studies are not always comparable, as they used different questionnaires and protocols, with some studies even using their own custom questionnaires. Henry et al. [115] compared the efficacy of TMT and TRT, finding that both methods led to self-reported improvements in tinnitus, but that TRT was superior to TMT in reducing tinnitus-related distress, especially in the group of patients for whom “tinnitus is a very big problem.” Most of the improvement induced by TMT was achieved during the first 3–6 months of treatment, while TRT induced a steady improvement over the course of the treatment (18 months). A more recent study, however, showed that TMT and TRT had similar effects on tinnitus when both were associated with counselling [170]. Finally, a randomised controlled study showed that TRT (masker + counselling) significantly improved tinnitus handicap [151].

Neuromonics approach.

Neuromonics treatment consists of an acoustic stimulation combining music and broadband noise [106, 107, 114]. 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. Patients undergoing Neuromonics treatment are permitted to completely mask their tinnitus in the early stages of the treatment to maximise relief and relaxation (2 months). This initial stage is also intended to maximise the amount of stimulation of the deprived sensory region. In a second stage (4 months), the patients are discouraged from masking their tinnitus to facilitate desensitisation [107]. 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. Overall, however, they reported clinically significant changes in tinnitus severity at 6 months for 86% of Neuromonics patients. Few independent studies of Neuromonics have been conducted. Of note, Newman and Sandridge [145] 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.

Notched music stimulation.

A recent approach investigated the effects of notched music on tinnitus, the notch (1 octave width) being chosen to correspond to the tinnitus pitch [148, 167]. The notched music was intended to reduce tinnitus-related cortical activity within the notch, possibly through increasing lateral inhibition [150]. After 12 months of regular listening, this approach was reported to reduce self-reported tinnitus loudness, by around two points on a ten-point scale (eight subjects were treated with the notched music). The authors interpreted this approach as reversing the “maladaptive cortical reorganisation by the notched music training”.

Customised music stimulation.

It has been suggested that tinnitus may result from the central changes accompanying hearing loss [146]. 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. Recently, an RCT investigated the effects of their own product aimed at reversing the tinnitus-related central changes using a customised music stimulation [137]. Tinnitus severity was significantly reduced according to the THQ questionnaire (by 34%). 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.

Dietary and alternative therapies

Recommendation against There is evidence that dietary and alternative therapies (e. g. 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.

Ginkgo biloba is the most commonly used herbal supplement for tinnitus. The two latest systematic reviews included three RCTs on Ginkgo biloba for tinnitus as a primary complaint [121, 173]. A Cochrane review, first published in 2004 and most recently updated in 2013, concluded that Ginkgo biloba was not effective [121]. A second systematic review included five RCTs, with most trials having low methodological rigour [173]. The results were favourable toward Ginkgo, but the authors stated that a firm conclusion about efficacy was not possible. A meta-analysis pooled data from six RCTs and concluded that there was no benefit of Ginkgo over placebo [159]. Ginkgo biloba can interact with other blood thinners to cause serious bleeding and can worsen bleeding risk in patients with underlying clotting disorders [155].

Melatonin.

Melatonin is a hormone secreted by the pineal gland that is involved with regulation of the sleep–wake cycle. Three RCTs, with a total of 193 participants, studied melatonin to treat tinnitus, and each demonstrated benefit with the greatest improvement in those patients with severe tinnitus and insomnia [154]. However, given the small number of overall patients studied and the methodological limitations, including lack of a placebo group in the largest trial, these results should be interpreted with caution. Although another study demonstrated potential benefit for patients with concomitant sleep disturbance due to tinnitus, this study lacked randomisation, blinding, or placebo control [142]. Only one study reported possible adverse effects of melatonin, which included bad dreams and fatigue [160].

Dietary supplements.

Three RCTs of zinc as a treatment for tinnitus, with a total of 205 participants, showed inconsistent results [97, 103, 104]. It was suggested that benefit could be associated with underlying zinc deficiency.

Several other dietary supplements have been used for tinnitus, including lipoflavonoids, garlic, homeopathy, traditional Chinese/Korean herbal medicine, honeybee larvae, and other various vitamins and minerals. Evidence for the efficacy of these therapies for tinnitus does not exist [155].

No recommendation There is evidence for safety but little high-level evidence for the effectiveness of acupuncture. Recommendation is based on systematic review.

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. A systematic review in 2012 on acupuncture for the treatment of tinnitus included nine RCTs, with a total of 431 participants [132]. 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. 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 [132]. 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.

4.2 Referral options and criteria, triage, and a stepwise proposal

A stepped-care approach that provides a standard pathway based on patient need, including the disciplines involved, assessments, and treatments at each stage, is presented in Fig. 5. The steps proposed in the flowchart are based on the studies executed within the framework of the current guideline and the consensus meetings held within the steering committee. The barriers and facilitators of each member-country of the TINNET project have been taken into consideration, with a gradual increase in the intensity of the care at each level to be implemented according to health-care policy, available resources and health-care coordination within the specific country, region, or state. Suggested cut-off scores on the THI and TQ have been included as an example. For other instruments on tinnitus severity, we refer the reader to Chap. 3.

Fig. 5 Criteria for assessment and treatment of tinnitus. CBT cognitive behavioural therapy, THI Tinnitus Handicap Inventory, TQ Tinnitus Questionnaire Full size image

A stepwise multi-disciplinary approach

On the basis of the evidence described at present, we suggest that a CBT-based approach, whether in groups or individually, is the most evidence-based choice for effectively relieving tinnitus complaints. Tinnitus treatment aimed at the sound-perception level, such as sound therapy, including the use of hearing aids prescribed for tinnitus relief only, masking devices, ear-level sound generators, sound perceptual training, or other sound generating technology, however, has not been proven to have an additional effect on counselling or CBT, or as a standalone treatment. 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. Research suggests that next to otolaryngological/medical diagnostics, an overall CBT-based framework in tinnitus management is advisable, from audiological diagnostics (assessment of hearing and prescription of hearing aids if indicated to increase hearing function) and tinnitus counselling to psychological diagnostics and tinnitus treatment, since all studies showed benefits from some form of education, information, and/or counselling initially for all patients, and for the more severely impaired a more intensive CBT treatment. Moreover, tinnitus standard care might be best organised in a multi-disciplinary manner, using a stepped-care approach [13, 174], gradually increasing intensity of treatment in steps, so that most patients can be treated effectively with a fairly short process (diagnostics and information/education), and additional treatment steps can be indicated for those suffering on a more severe level.