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Cited by 135Hearing, Cochlea, Tinnitus, GeneticsHearing Loss and RehabilitationNoise Effects and Management

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

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Sereda, Magdalena, Xia, Jun, El Refaie, Amr, Hall, Deborah A, Hoare, Derek J·2018·Cochrane Database of Systematic Reviews
DOI 10.1002/14651858.cd013094.pub2PMC PMC6517157
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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 METHODS: 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Ovid MEDLINE; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials.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 onlyOne 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 onlyThree 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. 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

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  • There is a lack of reliable and consistent evidence on the efficacy of individual and combination tinnitus treatments.

    “There is a lack of reliable and consistent evidence on the efficacy of the individual and combination treatments, such as audiological care and psychological treatment.”

    From Combining the unequal variance signal detection model with the health belief model to optimize shared decision making in tinnitus patients: part 2—patient profiling (2025) · cites this paper as Sereda et al., 2018

    The Authors’ conclusions (Background; page unavailable) find low-quality evidence and insufficient evidence to compare hearing aids, sound generators, and combination devices. The review concerns sound therapy, however, and does not establish a lack of reliable evidence for psychological treatment or for audiological care and psychological treatment combined. (LLM, conf=0.87)

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  • The lack of reliable and consistent evidence on tinnitus treatment efficacy is due to different study designs and lack of reproducible results.

    “This is due to different study designs and lack of reproducible results (Fuller et al., 2020; Hoare et al., 2014; Sereda et al., 2018).”

    From Combining the unequal variance signal detection model with the health belief model to optimize shared decision making in tinnitus patients: part 2—patient profiling (2025) · cites this paper as Sereda et al., 2018

    The Discussion (page unavailable) says evidence for the effectiveness of sound therapy is lacking, and identifies study limitations including risk of bias and imprecision. It does not attribute that gap to a lack of reproducible results; the Methods (page unavailable) instead describes three pooled studies as having similar, non-significant effect estimates. The review also concerns sound therapy specifically, rather than tinnitus treatments generally. (LLM, conf=0.84)

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Research works printed but not linked: 15

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Authors
Sereda, M., Xia, J., El Refaie, A., Hall, D. A., & Hoare, D. J.
Affiliations
  • University of Nottingham (GB)
  • University College Cork; Department of Speech and Hearing Sciences; Cork Ireland
ORCID
Venue
Cochrane Database of Systematic Reviews
Publisher
Wiley
Published
2018-12-27
Volume
2018
Issue
12
Pages
CD013094-CD013094
ISSN
  • 1361-6137 (ISSN-L)
  • 1465-1858
DOI
10.1002/14651858.cd013094.pub2
PMC
PMC6517157
OpenAlex
W2908315352
Cited by
135
References
135
Citations by year
2026: 4 · 2025: 12 · 2024: 16 · 2023: 25 · 2022: 23 · 2021: 23 · 2020: 17 · 2019: 7 · 2018: 3 · 2017: 4 · 2016: 1
FWCI
2.32
Type
journal article
Language
en
Open access
Locations
  • Cochrane Database of Systematic Reviews (publishedVersion)
  • Europe PMC (PubMed Central) (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
  • Arrow@dit (Dublin Institute of Technology) (acceptedVersion)
  • Repository@Nottingham (University of Nottingham) (acceptedVersion, other-oa)
  • Repository@Nottingham (University of Nottingham) (submittedVersion, cc-by)
  • Cork Open Research Archive (University College Cork, Ireland) (submittedVersion)
Funders
  • U.S. Department of Veterans Affairs (C9230-C)
  • Stiftelsen Tysta Skolan
  • Riksbankens Jubileumsfond
  • Oticon Fonden
Topics
  • Life Sciences › Neuroscience › Sensory Systems › Hearing, Cochlea, Tinnitus, Genetics
  • Life Sciences › Neuroscience › Cognitive Neuroscience › Hearing Loss and Rehabilitation
  • Health Sciences › Health Professions › Speech and Hearing › Noise Effects and Management
Keywords
tinnitus, sound therapy, hearing aids, sound generator, tinnitus management, tinnitus loudness, health-related quality of life, depressive symptoms, generalized anxiety disorder, adverse effects, adults, tinnitus retraining therapy, cognitive behavioral therapy, relaxation training, information and advice, ear infection, skin irritation
MeSH terms
Acoustic Stimulation, Adult, Hearing Aids, Humans, Sound, Tinnitus, Randomized Controlled Trials as Topic

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