Cover of Evidence review for sound therapy and amplification devices

Evidence review for sound therapy and amplification devices

Tinnitus: assessment and management

Evidence review M

NICE Guideline, No. 155

Authors

.

London: National Institute for Health and Care Excellence (NICE); .
ISBN-13: 978-1-4731-3711-0
Copyright © NICE 2020.

1. Sound therapy and amplification devices

1.1. Introduction

Hearing loss is a common factor underlying tinnitus, although some people with normal hearing also experience tinnitus. Loss of hearing is often an unnoticeable and gradual process and many people are surprised when they are told that they have a hearing loss. It is quite common for people to assume, incorrectly, that it is their tinnitus rather than their hearing loss that is causing hearing difficulties. Management of hearing loss in adults is covered by NICE guideline NG98. In this review we focus on only those people who have tinnitus.

Nationally, there are differences in how people with a hearing loss and tinnitus are treated. In some locations people with tinnitus and a measurable hearing loss are offered hearing aids to reduce the impact of their tinnitus.

People who have tinnitus often report that it is more noticeable and bothersome in a quiet environment, for example at night, and that listening to other sounds can make it less intrusive. The deliberate use of any sound to reduce tinnitus awareness or reduce the distress associated with it can be called sound enrichment or sound therapy. Sound therapy/ enrichment can be used as a self-help technique or as a component of a broader tinnitus management programme delivered with the support of a healthcare professional. Various types of sound are used including relaxing music, natural sounds such as waves and white noise.

Using sound to help manage tinnitus is common but practice varies across the country and may include hearing aids with a sound generator activated, wearable sound devices or other types of sound enrichment. Sound therapy/enrichment covers many different aspects from wearable devices, environmental sound, smart phone apps, bedside/ table top generators. The provision of sound therapy devices is inconsistent across the country.

The purpose of this review is to identify evidence as to whether hearing aids, sound therapy/ sound enrichment are a clinically and cost effective way of reducing the impact of tinnitus.

1.2. Review question: What is the clinical and cost effectiveness of sound therapy and sound enrichment for people with tinnitus?

1.3. PICO table

For full details see the review protocol in appendix A.

Table 1. PICO characteristics of sound therapy review question.

Table 1

PICO characteristics of sound therapy review question.

1.4. Review question: What is the clinical and cost effectiveness of amplification devices for people with tinnitus who do not require an amplification device for a hearing loss alone?

1.5. PICO table

For full details see the review protocol in appendix A.

Table 2. PICO characteristics of amplification devices review question.

Table 2

PICO characteristics of amplification devices review question.

1.6. Clinical evidence

1.6.1. Included studies

The two review questions on sound therapy (including sound enrichment) and amplification devices were combined into a single evidence review.

A Cochrane review of sound therapy (using amplification devices and/or sound generators) with 8 studies45 was included in its entirety as it matched our protocols. The methods of data analysis and quality assessment for this part of the review are therefore in accordance with the methods described in the Cochrane review.

NICE methods include the avoidance of an overall risk of bias assessment of “unclear”, whilst Cochrane methods allow the use of “unclear”. For the included Cochrane review, the Cochrane ‘risk of bias’ tool in Review Manager 5.3 was used for risk of bias assessments, whereas NICE methods include the use of Cochrane ‘risk of bias’ 2.0 tool. For data analysis, NICE methods consist of the use of Peto odds ratio analyses where there are zero events in either arm or a less than 1% event rate. Cochrane reviews however include the use of risk ratio analyses where there are zero events in both arms of included studies. Additionally, Cochrane selected different populations for potential subgroup analyses to investigate heterogeneity (see Appendix A: for our selected subgroup populations). The subgroups selected by Cochrane were: hearing loss, differing baseline tinnitus symptom severity and baseline anxiety or depression.

Two further randomised controlled trials that were outside the scope of the Cochrane review were also included in our review.27, 28 These compared customised sound therapy (pitch matched) to non-customised sound therapy (broadband noise), and customised sound therapy (altered music) to sound enrichment, respectively.

The included studies are summarised in Table 3 below.27, 28 Evidence from these studies is summarised in the clinical evidence summaries below (Table 4, Table 5, Table 6 and Table 7).

See also the study selection flow chart in appendix C, study evidence tables in appendix D, forest plots in appendix E and GRADE tables in appendix H.

1.6.2. Excluded studies

One Cochrane review was excluded (Hoare 201424 as it was superseded by the more recent Cochrane review).

See the excluded studies list in appendix H.

1.6.3. Summary of clinical studies included in the evidence review

Table 3. Summary of studies included in the evidence review.

Table 3

Summary of studies included in the evidence review.

See appendix D for full evidence tables.

1.6.4. Quality assessment of clinical studies included in the evidence review

Table 4. Clinical evidence summary: Amplification (hearing aid) only versus ear-level sound generator only.

Table 4

Clinical evidence summary: Amplification (hearing aid) only versus ear-level sound generator only.

Table 5. Clinical evidence summary: Amplification and sound generator (combination hearing aid) versus amplification (hearing aid) only.

Table 5

Clinical evidence summary: Amplification and sound generator (combination hearing aid) versus amplification (hearing aid) only.

Table 6. Clinical evidence summary: Customised sound therapy versus non-customised sound therapy (broadband noise).

Table 6

Clinical evidence summary: Customised sound therapy versus non-customised sound therapy (broadband noise).

Table 7. Clinical evidence summary: Customised sound therapy (altered music) versus sound enrichment.

Table 7

Clinical evidence summary: Customised sound therapy (altered music) versus sound enrichment.

See appendix F for full GRADE tables.

1.7. Economic evidence

1.7.1. Included studies

No relevant health economic studies were identified.

1.7.2. Excluded studies

No health economic studies that were relevant to this question were excluded due to assessment of limited applicability or methodological limitations.

See also the health economic study selection flow chart in appendix G.

1.7.3. Unit costs

Table 8. UK costs of sound therapy and amplification.

Table 8

UK costs of sound therapy and amplification.

1.8. Evidence statements

1.8.1. Clinical evidence statements

Amplification (hearing aid) only versus ear-level sound generator only

One study (n=91) were included in this comparison; no clinical evidence was reported for the critical outcomes: tinnitus distress, tinnitus annoyance, general quality of life and tinnitus-related quality of life. There was no clinical difference between amplification devices (hearing aid) and sound generators in terms of improving tinnitus severity. The overall quality of the evidence was low due to risk of bias and imprecision.

Amplification and ear-level sound generator (combination hearing aid) versus amplification (hearing aid) only

Three studies (n=114) were included in this comparison; no clinical evidence was reported for the critical outcomes: tinnitus distress, tinnitus annoyance, general quality of life and tinnitus-related quality of life. There was no clinical difference between combination hearing aids and hearing aids in terms of improving tinnitus severity. The overall quality of the evidence was Low due to risk of bias and imprecision.

Customised sound therapy versus non-customised sound therapy (broadband noise)

One study (n=36) was included in this comparison; no clinical evidence was reported for the critical outcomes: tinnitus distress, tinnitus annoyance, general quality of life and tinnitus-related quality of life. There was no clinical difference between customised sound therapy and non-customised sound therapy (broadband noise) in terms of improving depression, anxiety and tinnitus loudness. There was clinical benefit of customised sound therapy in terms of tinnitus severity. The overall quality of the evidence was Very Low due to risk of bias and imprecision.

Customised sound therapy (altered music) versus sound enrichment

One study (n=28) was included in this comparison; no clinical evidence was reported for the critical outcomes: tinnitus annoyance, general quality of life and tinnitus-related quality of life. There was a clinical benefit of customised sound therapy in terms of tinnitus distress and tinnitus severity. There was no clinical difference between altered music and sound enrichment for the outcomes of depression and anxiety. The overall quality of evidence was Low due to risk of bias and imprecision.

1.8.2. Health economic evidence statements

  • No relevant economic evaluations were identified.

1.9. The committee’s discussion of the evidence

1.9.1. Interpreting the evidence

1.9.1.1. The outcomes that matter most

Tinnitus distress, annoyance and tinnitus awareness were critical outcomes as they were thought to be common factors for people with tinnitus and impact their quality of life. Quality of life (tinnitus-related) and general quality of life were also critical outcomes due to their impact on the person with tinnitus.

Tinnitus loudness, anxiety, depression, sleep, safety, tolerability and side effects were thought to be important outcomes.

1.9.1.2. The quality of the evidence

A Cochrane review was identified and was included in this review. The Cochrane review identified evidence for sound therapy (using amplification devices and/or sound generators) for the management of tinnitus. We included two additional studies on sound therapy.

Amplification devices

The Cochrane review identified studies which evaluated the use of hearing aids and combination hearing aids. One study evaluated the use of hearing aids compared to sound generators and reported outcome data for tinnitus severity at different time-points (3 months, 6 months and 12 months). Three studies were identified which compared combination hearing aids (amplification and sound generator) with a standard hearing aid. These three studies also reported outcome data for tinnitus severity. Overall, the evidence was low quality due to risk of bias and imprecision.

Sound therapy

Two randomised controlled trials (RCTs) relating to sound therapy were included in addition to the studies found in the relevant Cochrane Review. They were not included in the Cochrane Review as they compared one type of sound therapy to another. The Cochrane Review included studies that compared amplification devices, ear-level sound generators or combination devices to either placebo or education/information only with no device or in comparison to one another. The two trials evaluated customised sound therapy; the evidence was graded from very low to low for the various outcomes due to risk of bias and imprecision.

1.9.1.3. Benefits and harms
Amplification devices

The committee recommended amplification devices (hearing aids and combination devices) for those who present with tinnitus and have hearing loss. This was a strong recommendation and is in line with the NICE Hearing loss guideline (NG98) which recommends offering hearing aids to those whose ability to communicate and hear is hampered by their hearing loss. The committee agreed that this should also apply to children and young people, although they are not covered by NG98.

For those with hearing loss but no self-perceived hearing difficulties the committee recommended that amplification devices should be considered. We did not find evidence for this population but the committee noted that sometimes those with a hearing loss but no self-perceived hearing difficulties may not always be offered a hearing aid for their hearing loss alone, but with co-occurring tinnitus they may experience a benefit for both their tinnitus and their hearing loss. The committee agreed to make a recommendation for further research to evaluate amplification devices for people with tinnitus who have hearing loss but no perceived hearing difficulties (see Appendix I:).

The committee also noted that there was no evidence for the use of amplification devices for people who are d/Deaf or who have a severe-to-profound hearing loss. Standard care for tinnitus in this population is not feasible, it is important that effective interventions are developed and investigated. The committee agreed that a research recommendation is made for the use of amplification devices for this population (see Appendix I:).

The committee recommended that people with tinnitus and normal hearing should not be offered amplification devices because there is unlikely to be an improvement to the impact of the tinnitus and amplification of sound where it is not required is inappropriate.

Sound therapies

With the limited evidence available for sound therapy as a sole intervention, the committee agreed that a recommendation cannot be made for its use in isolation. There are many different types of sound therapy and there was insufficient evidence for any particular type. The use of customised sound therapies is not part of current clinical practice in the UK. Two studies included in this review evaluated customised sound therapies. Whilst, these studies showed evidence of clinical benefit for customised sound therapies, the committee agreed that this evidence was insufficient for a practice recommendation at present. The evidence for sound therapy in combination with other interventions is discussed in evidence review P, where a research recommendation was made for the evaluation of sound therapy with tinnitus support.

Occasionally people report an increase or change in their tinnitus when using sound or hearing aids. While changes to the sound processing settings may help to alleviate this for some people, it is important to be alert to this possibility and include this in the discussion of the various management options.

1.9.2. Cost effectiveness and resource use

There were no economic evaluations available for this review question. The committee indicated that offering amplification devices (hearing aids) to people with tinnitus and hearing loss (that impacts their ability to communicate and hear) should be in line with NG98. However, the committee have also included children in their recommendation which is an extension to NG98 but as this recommendation is consistent with current practice it would not lead to added expenditure.

The committee indicated the existence of a subgroup of people who have a hearing loss (that they do not perceive to affect their ability to communicate and hear) alongside bothersome tinnitus that may also benefit from hearing aids. Due to the economic uncertainty and the potential for added expenditure, the committee concluded that this should be a ‘consider’ recommendation and be determined by clinicians on a case by case basis (as is current practice) as opposed to offering these devices routinely.

Finally, the committee provided a negative recommendation for the provision of hearing aids in the absence of hearing loss (as there is potential for harm) which has the potential to generate modest cost savings.

Sound therapy and sound enrichment devices are widely used in the NHS and the committee highlighted that from their clinical experience people with tinnitus do benefit from the use of these interventions. However, a concern raised by the committee was the existence of many different variants of sound therapy from environmental sounds (i.e. windows open) or audio generated from one’s mobile phone (which would not incur cost for the NHS) to expensive sound masking and customisable devices where the sounds generated are tuned specifically for a person’s tinnitus. As there is a lack of clarity on which of these variants would be most clinically effective and cost-effective, the committee opted to form a research recommendation to explore this question further.

1.9.3. Other factors the committee took into account

Whilst people with tinnitus and a hearing loss that affects their ability to communicate are covered by NICE guideline NG98 (recommendation 1.6.1) and they should be receiving hearing aids currently, there are a group with hearing loss (but no self- perceived hearing difficulties) where practice is more variable. Some units may need to review their local guidelines for these people and amplification devices will need to be considered on a case by case basis. The person’s choice is important as different management strategies will suit people differently. These strategies should be offered with a discussion of the possible benefits and the alternatives available. The rationale for using hearing aids should be clearly explained as some people find it confusing that adding sound can help.

Lay members reported that there is a lack of knowledge in the general population about how hearing aids may help them cope with their tinnitus. This, coupled with the belief that ‘nothing can be done about tinnitus’, means that many people with hearing difficulties but who do not have hearing aids do not consult their GP about their tinnitus. Some who have hearing difficulties do not report having tinnitus. This may mean they are referred inappropriately and do not receive the tinnitus support they need. There are some people who have chosen not to accept hearing aids for their hearing difficulties but have welcomed them when they learn it may also help with their tinnitus.

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Appendices

Appendix B. Literature search strategies

The literature searches for this review are detailed below and complied with the methodology outlined in Developing NICE guidelines: the manual.34

For more detailed information, please see the Methodology Review.

B.1. Clinical search literature search strategy

Searches were constructed using a PICO framework where population (P) terms were combined with Intervention (I) and in some cases Comparison (C) terms. Outcomes (O) are rarely used in search strategies for interventions as these concepts may not be well described in title, abstract or indexes and therefore difficult to retrieve. Search filters were applied to the search where appropriate.

Table 12. Database date parameters and filters used

Medline (Ovid) search terms

Embase (Ovid) search terms

Cochrane Library (Wiley) search terms

CINAHL (EBSCO) search terms

B.2. Health Economics literature search strategy

Health economic evidence was identified by conducting a broad search relating to the tinnitus population in NHS Economic Evaluation Database (NHS EED – this ceased to be updated after March 2015) and the Health Technology Assessment database (HTA) with no date restrictions. NHS EED and HTA databases are hosted by the Centre for Research and Dissemination (CRD). Additional searches were run on Medline and Embase for health economics and quality of life studies.

Table 13. Database date parameters and filters used

Medline (Ovid) search terms

Embase (Ovid) search terms

NHS EED and HTA (CRD) search terms

Appendix D. Clinical evidence tables

Download PDF (198K)

Appendix H. Excluded studies

H.2. Excluded health economic studies

None.

Appendix I. Research recommendations

I.1. Amplification devices for people who are d/Deaf or who have a severe-to-profound hearing loss

Research question: What is the clinical and cost effectiveness of amplification devices for people who are d/Deaf or who have a severe-to-profound hearing loss?

Why this is important:

Improving access to sound can be beneficial for those with tinnitus and hearing loss. There is no current evidence regarding the effectiveness of amplification, hearing aids or implant devices, for managing tinnitus in those who may only receive limited hearing benefit from the amplification. However it may be that even some hearing benefit from amplification may improve perception of tinnitus.

Criteria for selecting high-priority research recommendations

I.2. Amplification devices for people with tinnitus who have hearing loss but no perceived hearing difficulties

Research question: What is the clinical and cost effectiveness of fitting amplification devices in people with tinnitus who have hearing loss but no perceived hearing difficulties?

Why this is important:

People with mild hearing loss do not always report difficulty with hearing and/or communication, but may present in the tinnitus clinic because they have noticed tinnitus and upon testing their hearing, an underling hearing loss is detected. Amplification devices (e.g. hearing aids) should be available for people with hearing loss who present with hearing difficulties and have been recommended for people with hearing loss and tinnitus in order to manage tinnitus. For those who do not experience hearing and/or communication difficulties, it is uncertain whether or not hearing aids may be of benefit for managing tinnitus.

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Population: Children, young people and adults presenting with tinnitus-who have a hearing loss but no perceived hearing and/or communication difficulties Intervention(s): Amplification devices for those with hearing loss ○Hearing aids○Implantable (more...)