Sound therapy (using amplification devices or sound generators) for tinnitus

Review question

Is sound therapy (using amplification devices, sound generators or both) effective for tinnitus in adults?

Background

Tinnitus is the awareness of a sound in the ear or head without any outside source. It affects 10% to 15% of the adult population. About 20% of people with tinnitus experience symptoms that negatively affect their quality of life including sleep disturbances, difficulties with hearing and concentration, social isolation, anxiety, depression, irritation or stress. Tinnitus can be managed through education and advice, relaxation therapy, psychological therapy, or devices that improve hearing or generate sound such as sound generators or hearing aids. Sometimes drugs are prescribed to manage problems associated with tinnitus such as sleep problems, anxiety or depression. The purpose of this review is to evaluate the evidence from high-quality clinical trials to work out the effects of sound therapy (hearing aids, sound generators and combination hearing aids) on adults with tinnitus. We particularly wanted to look at the effects of sound therapy on tinnitus severity and any side effects.

Study characteristics

Our review identified eight randomised controlled trials with 590 participants in total. Seven studies looked at the effects of hearing aids, four combination hearing aids and three sound generators. Seven studies allocated participants into parallel groups and in one study participants tried each intervention in a random order. The outcomes that we looked for were severity of tinnitus symptoms, depression, anxiety, quality of life and side effects. In general, the risk of bias in the studies was unclear. There was also little or no use of blinding.

Key results

We did not find any data for our outcomes for any of our three main comparisons (comparing hearing aids, sound generators and combination devices with a waiting list control group, placebo or education/information only). There were also few data for our additional comparisons (comparing these devices with each other) and it was difficult to pool (combine) the data.

Hearing aid only versus sound generator device only

One study compared patients fitted with sound generators with those fitted with hearing aids and found no difference between them in their effects on our primary outcome, tinnitus symptom severity, at 3, 6 or 12 months. The use of both types of device was associated with a clinically significant reduction in tinnitus symptom severity.

Combination hearing aid versus hearing aid only

Three studies compared combination hearing aids/sound generators with hearing aids alone and measured tinnitus symptom severity. When we combined the data for tinnitus symptom severity we found no difference between them. The use of both types of device was again associated with a clinically significant reduction in tinnitus symptom severity.

Adverse effects were not assessed in any of the included studies.

None of the studies measured depressive symptoms or depression, anxiety symptoms or generalised anxiety, or other important outcomes of interest in this review.

Quality of evidence

Where outcomes that we were interested in for this review were reported, we assessed the quality of the evidence available as low. Using a hearing aid, sound generator or combination device might result in little or no difference in tinnitus symptom severity.

Authors' conclusions: 

There is no evidence to support the superiority of sound therapy for tinnitus over waiting list control, placebo or education/information with no device. There is insufficient evidence to support the superiority or inferiority of any of the sound therapy options (hearing aid, sound generator or combination hearing aid) over each other. The quality of evidence for the reported outcomes, assessed using GRADE, was low. Using a combination device, hearing aid or sound generator might result in little or no difference in tinnitus symptom severity.

Future research into the effectiveness of sound therapy in patients with tinnitus should use rigorous methodology. Randomisation and blinding should be of the highest quality, given the subjective nature of tinnitus and the strong likelihood of a placebo response. The CONSORT statement should be used in the design and reporting of future studies. We also recommend the use of validated, patient-centred outcome measures for research in the field of tinnitus.

Read the full abstract...
Background: 

Tinnitus affects 10% to 15% of the adult population, with about 20% of these experiencing symptoms that negatively affect quality of life. In England alone there are an estimated ¾ million general practice consultations every year where the primary complaint is tinnitus, equating to a major burden on healthcare services. Clinical management strategies include education and advice, relaxation therapy, tinnitus retraining therapy (TRT), cognitive behavioural therapy (CBT), sound enrichment using ear-level sound generators or hearing aids, and drug therapies to manage co-morbid symptoms such as insomnia, anxiety or depression. Hearing aids, sound generators and combination devices (amplification and sound generation within one device) are a component of many tinnitus management programmes and together with information and advice are a first line of management in audiology departments for someone who has tinnitus.

Objectives: 

To assess the effects of sound therapy (using amplification devices and/or sound generators) for tinnitus in adults.

Search strategy: 

The Cochrane ENT Information Specialist searched the Cochrane ENT Register; Central Register of Controlled Trials (CENTRAL, via the Cochrane Register of Studies); Ovid MEDLINE; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 23 July 2018.

Selection criteria: 

Randomised controlled trials (RCTs) recruiting adults with acute or chronic subjective idiopathic tinnitus. We included studies where the intervention involved hearing aids, sound generators or combination hearing aids and compared them to waiting list control, placebo or education/information only with no device. We also included studies comparing hearing aids to sound generators, combination hearing aids to hearing aids, and combination hearing aids to sound generators.

Data collection and analysis: 

We used the standard methodological procedures expected by Cochrane. Our primary outcomes were tinnitus symptom severity as measured as a global score on multi-item tinnitus questionnaire and significant adverse effects as indicated by an increase in self-reported tinnitus loudness. Our secondary outcomes were depressive symptoms, symptoms of generalised anxiety, health-related quality of life and adverse effects associated with wearing the device such as pain, discomfort, tenderness or skin irritation, or ear infections. We used GRADE to assess the quality of evidence for each outcome; this is indicated in italics.

Main results: 

This review included eight studies (with a total of 590 participants). Seven studies investigated the effects of hearing aids, four combination hearing aids and three sound generators. Seven studies were parallel-group RCTs and one had a cross-over design. In general, risk of bias was unclear due to lack of detail about sequence generation and allocation concealment. There was also little or no use of blinding.

No data for our outcomes were available for any of our three main comparisons (comparing hearing aids, sound generators and combination devices with a waiting list control group, placebo or education/information only). Data for our additional comparisons (comparing these devices with each other) were also few, with limited potential for data pooling.

Hearing aid only versus sound generator device only

One study compared patients fitted with sound generators versus those fitted with hearing aids and found no difference between them in their effects on our primary outcome, tinnitus symptom severity measured with the Tinnitus Handicap Inventory (THI) at 3, 6 or 12 months (low-quality evidence). The use of both types of device was associated with a clinically significant reduction in tinnitus symptom severity.

Combination hearing aid versus hearing aid only

Three studies compared combination hearing aids with hearing aids and measured tinnitus symptom severity using the THI or Tinnitus Functional Index. When we pooled the data we found no difference between them (standardised mean difference -0.15, 95% confidence interval -0.52 to 0.22; three studies; 114 participants) (low-quality evidence). The use of both types of device was again associated with a clinically significant reduction in tinnitus symptom severity.

Adverse effects were not assessed in any of the included studies.

None of the studies measured the secondary outcomes of depressive symptoms or depression, anxiety symptoms or generalised anxiety, or health-related quality of life as measured by a validated instrument, nor the newly developed core outcomes tinnitus intrusiveness, ability to ignore, concentration, quality of sleep and sense of control.

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