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Cochrane Database of Systematic Reviews

Audífonos para la hipoacusia leve a moderada en adultos

Information

DOI:
https://doi.org/10.1002/14651858.CD012023.pub2Copy DOI
Database:
  1. Cochrane Database of Systematic Reviews
Version published:
  1. 25 September 2017see what's new
Type:
  1. Intervention
Stage:
  1. Review
Cochrane Editorial Group:
  1. Cochrane ENT Group

Copyright:
  1. Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Authors

  • Melanie A Ferguson

    Correspondence to: NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust, Nottingham, UK

    [email protected]

    NIHR Nottingham Biomedical Research Centre, Division of Clinical Neuroscience, School of Medicine, University of Nottingham, Nottingham, UK

  • Pádraig T Kitterick

    NIHR Nottingham Biomedical Research Centre, Division of Clinical Neuroscience, School of Medicine, University of Nottingham, Nottingham, UK

  • Lee Yee Chong

    UK Cochrane Centre, Oxford, UK

  • Mark Edmondson‐Jones

    NIHR Nottingham Biomedical Research Centre, Division of Clinical Neuroscience, School of Medicine, University of Nottingham, Nottingham, UK

  • Fiona Barker

    Department of Clinical and Experimental Medicine, University of Surrey, Guildford, UK

  • Derek J Hoare

    NIHR Nottingham Biomedical Research Centre, Division of Clinical Neuroscience, School of Medicine, University of Nottingham, Nottingham, UK

Contributions of authors

MF conceived the review question, selected which studies to review, extracted data, assessed study quality, wrote the protocol and review, and co‐ordinated comments from the authors and reviewers.

PK extracted data, assessed study quality, conducted the data analyses, and contributed substantially to the writing of the protocol and review.

LY provided methodological advice on the protocol and the review.

MEJ provided statistical advice and conducted an independent verification of the data analyses.

FB joined as a co‐author for the full review, selected which studies to include and provided feedback on the review.

DH selected which studies to include, assessed study quality, and provided guidance and critical comment on the draft protocol and review.

Sources of support

Internal sources

  • National Institute for Health Research, UK.

    MF, PK, MEJ and DH are funded by the National Institute for Health Research (NIHR) Biomedical Research Unit Programme, however the views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health

External sources

  • National Institute for Health Research, UK.

    Infrastructure funding for Cochrane ENT

Declarations of interest

Melanie Ferguson: none known.

Pádraig T Kitterick: PK's employing organisation has received financial support from Cochlear Europe Ltd. and support in kind from Phonak UK Ltd. to conduct a multicentre clinical trial of cochlear implantation in single‐sided deafness co‐ordinated by PK. PK has accepted the hospitality of Cochlear Europe Ltd. to attend and speak at national and international scientific meetings.

Lee Yee Chong: none known.

Mark Edmondson‐Jones: none known.

Fiona Barker: none known

Derek Hoare: none known.

Acknowledgements

This project was supported by the National Institute for Health Research, via Cochrane Infrastructure, Cochrane Programme Grant or Cochrane Incentive funding to Cochrane ENT. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Systematic Reviews Programme, NIHR, NHS or the Department of Health.

We acknowledge Helen Henshaw who helped to conceive the review question. We would also like to acknowledge Saoussen Ftouh (National Guideline Centre) for methodological support and advice. We thank the Cochrane ENT team for their invaluable help: Samantha Faulkner who designed the search strategy, Martin Burton for strategic advice and Jenny Bellorini for her support and substantial general advice. Finally, we thank the authors of included studies for their willingness to share information and respond to our queries.

Version history

Published

Title

Stage

Authors

Version

2017 Sep 25

Hearing aids for mild to moderate hearing loss in adults

Review

Melanie A Ferguson, Pádraig T Kitterick, Lee Yee Chong, Mark Edmondson‐Jones, Fiona Barker, Derek J Hoare

https://doi.org/10.1002/14651858.CD012023.pub2

2015 Dec 22

Hearing aids for mild to moderate hearing loss in adults

Protocol

Melanie A Ferguson, Pádraig T Kitterick, Mark Edmondson‐Jones, Derek J Hoare

https://doi.org/10.1002/14651858.CD012023

Differences between protocol and review

The Types of participants section in the protocol was: "Adults (≥ 18 years old) with mild or moderate hearing loss, as defined by pure‐tone thresholds in the better‐hearing ear averaged across four frequencies (0.5 kHz, 1.0 kHz, 2.0 kHz and 4.0 kHz) of 26 to 40 dB HL (mild hearing loss) and 41 to 60 dB HL (moderate hearing loss). In the absence of confirmation that all participants in a study met these criteria (i.e. where participant‐level data were not reported or could not be obtained), we will include studies where the reported participant characteristics for the mean four‐frequency average as described above. If a mean frequency average is offered for a combination of frequencies other than 0.5 kHz, 1.0 kHz, 2.0kHz and 4.0 kHz, we will use studies where the reported value falls between 26 to 40 dB HL (mild hearing loss) or 41 to 60 dB HL (moderate hearing loss). If only qualitative descriptions of mild and moderate hearing loss are given with no supporting audiometric data, we will include such studies but will not include them in the meta‐analysis" (Ferguson 2015).

We revised the Types of participants section because there was concern about introducing a potential bias in the selection of studies such that those studies that were reported in less detail (e.g. group mean hearing threshold data or qualitative descriptions) were more likely to be included than those that either reported in more detail or provided us with participant‐level data. To minimise the risk of bias from the revision of the protocol, the revised definition for Types of participants and the final decisions about which studies met the inclusion criteria were subjected to an independent review by an external expert committee to ensure the decisions were appropriate for the review question.

The protocol stated that MF and FB would extract the data, but instead this was completed by MF and PK. The protocol did not state what would happen in the event of a disagreement on a risk of bias judgement between MF and PK. Where this occurred, DH was charged with making a final judgement. The protocol stated that MF would review the 'Summary of findings' table, but in addition LYC (who was not an author on the review protocol) also reviewed the 'Summary of findings' table.

The protocol stated in Measures of treatment effect that we would use the standardised mean difference at the trial endpoint. We instead used the mean difference for the hearing‐specific health‐related quality of life outcome at the trial endpoint as these data were collected using the same instrument (HHIE) across all studies that were included in the meta‐analysis.

Some of the pre‐specified subgroup and funnel plot analyses were not performed as the data were not available or were too limited.

We performed unplanned subgroup analyses for the hearing‐specific quality of life and listening ability outcomes due to the numerous participant and methodological differences between the Veterans Association studies and the other study included in the analyses (Humes 2017).

We made a minor adjustment to the wording of the review Objectives, changing 'effectiveness' to 'effects' to capture our interest in both positive and negative outcomes.

Keywords

MeSH

Medical Subject Headings Check Words

Aged; Aged, 80 and over; Humans;

PICOs

Population
Intervention
Comparison
Outcome

The PICO model is widely used and taught in evidence-based health care as a strategy for formulating questions and search strategies and for characterizing clinical studies or meta-analyses. PICO stands for four different potential components of a clinical question: Patient, Population or Problem; Intervention; Comparison; Outcome.

See more on using PICO in the Cochrane Handbook.

Study flow diagram.
Figures and Tables -
Figure 1

Study flow diagram.

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
Figures and Tables -
Figure 2

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figures and Tables -
Figure 3

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Forest plot of comparison: 1 Hearing aids versus no/placebo hearing aids, outcome: 1.1 Hearing‐specific health‐related quality of life. Assessed using Hearing Handicap Inventory for the Elderly (HHIE) in all studies.
Figures and Tables -
Figure 4

Forest plot of comparison: 1 Hearing aids versus no/placebo hearing aids, outcome: 1.1 Hearing‐specific health‐related quality of life. Assessed using Hearing Handicap Inventory for the Elderly (HHIE) in all studies.

Forest plot of comparison: 1 Hearing aids versus no/placebo hearing aids, outcome: 1.2 Health‐related quality of life.
Figures and Tables -
Figure 5

Forest plot of comparison: 1 Hearing aids versus no/placebo hearing aids, outcome: 1.2 Health‐related quality of life.

Forest plot of comparison: 1 Hearing aids versus no/placebo hearing aids, outcome: 1.3 Listening ability.
Figures and Tables -
Figure 6

Forest plot of comparison: 1 Hearing aids versus no/placebo hearing aids, outcome: 1.3 Listening ability.

Comparison 1 Hearing aids versus no/placebo hearing aids, Outcome 1 Hearing‐specific health‐related quality of life.
Figures and Tables -
Analysis 1.1

Comparison 1 Hearing aids versus no/placebo hearing aids, Outcome 1 Hearing‐specific health‐related quality of life.

Comparison 1 Hearing aids versus no/placebo hearing aids, Outcome 2 Health‐related quality of life.
Figures and Tables -
Analysis 1.2

Comparison 1 Hearing aids versus no/placebo hearing aids, Outcome 2 Health‐related quality of life.

Comparison 1 Hearing aids versus no/placebo hearing aids, Outcome 3 Listening ability.
Figures and Tables -
Analysis 1.3

Comparison 1 Hearing aids versus no/placebo hearing aids, Outcome 3 Listening ability.

Summary of findings for the main comparison. Hearing aids versus no hearing aids for mild to moderate hearing loss in adults

Hearing aids versus no hearing aids for mild to moderate hearing loss in adults

Patient or population: adults with mild to moderate hearing loss
Setting: audiology services and clinics
Intervention: hearing aids
Comparison: no hearing aids (waiting list) or placebo hearing aids

Outcomes

No. of participants
(studies)

Anticipated absolute effects (95% CI)

Quality

What happens*

Without hearing aids

With hearing aids

Difference

Hearing‐specific HRQoL

assessed with: HHIE (range 0 to 100)

Follow‐up: range 6 to 16 weeks

No. of participants: 722 (3 RCTs)

The mean hearing‐specific HRQoL score was 39

Mean 26 lower (42 to 11 lower)

⊕⊕⊕⊝
MODERATE 1,2,3,4

Lower score indicates better hearing‐specific HRQoL. The mean difference corresponds to a large effect size (SMD ‐1.38, 95% CI ‐2.02 to ‐0.75) favouring hearing aids.

Health‐related QoL

assessed with: WHO‐DAS II (range 0 to 100) and the SELF (range 54 to 216)

Follow‐up: range 2 months to 16 weeks

No. of participants: 568 (2 RCTs)

SMD 0.38 lower (0.55 lower to 0.21 lower)

⊕⊕⊕⊝
MODERATE 1,4

Lower score indicates better HRQoL. The SMD corresponds to a small effect size favouring hearing aids, which is equivalent to a 6‐point decrease (9‐ to 3‐point decrease) on the 0 to 100 scale of the WHO‐DAS II5.

Listening ability

assessed with: PHAP (range 0 to 1) and APHAB (range 0 to 100)

Follow‐up: 6 weeks to 2 months

No. of participants: 534 (2 RCTs)

SMD 1.88 lower (3.24 lower to 0.52 lower)

⊕⊕⊕⊝
MODERATE 1,2,3,4

Lower score indicates improved listening ability. The SMD corresponds to a large effect size favouring hearing aids, which is equivalent to a 29‐point decrease (50‐ to 8‐point decrease) on the 0 to 100 scale of the APHAB6.

Adverse effect ‐ pain

No. of participants: 48

(1 RCT)

Adverse effects related to pain were measured in 1 study: none were reported.

⊕⊝⊝⊝

VERY LOW7

There was too little information to estimate the risk of pain.

Adverse effect ‐ noise‐induced hearing loss

No. of participants: 48

(1 RCT)

Adverse effects related to noise‐induced hearing loss were measured in 1 study: none were reported.

⊕⊝⊝⊝

VERY LOW7

There was too little information to estimate the risk of noise‐induced hearing loss.

*The equivalent change in the intervention group (and its 95% confidence interval) is based on the standard deviation in the comparison group from a representative study (see footnotes for each outcome) and the relative effect of the intervention (and its 95% CI).

APHAB: Abbreviated Profile of Hearing Aid Benefit; CI: confidence interval; HHIE: Hearing Handicap Inventory for the Elderly; HRQoL: health‐related quality of life; MD: mean difference; PHAP: Profile of Hearing Aid Performance; RCT: randomised controlled trial; SELF: Self Evaluation of Life Function; SMD: standardised mean difference; WHO‐DAS II: WHO Disability Assessment Schedule II

GRADE Working Group grades of evidence
High quality: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

1Quality of evidence downgraded by one level because all studies have either a rating of unclear and/or high risk bias in at least one of these domains: selection bias, performance and/or detection bias.
2We considered downgrading for inconsistency due to observed statistical heterogeneity but we did not apply this. The data consistently showed large beneficial effects of using hearing aids for mild to moderate hearing loss despite the apparent differences in study designs and populations. Our confidence in the size of the effect is not affected.
3We considered downgrading due to indirectness as some data were obtained after a short follow‐up period (six weeks) but we did not apply this. Large beneficial effects were observed regardless of duration of follow‐up.
4We considered downgrading due to indirectness as some analyses included data from male military veterans but we did not apply this. Effect sizes were consistent within each outcome despite differences in study samples and designs (small beneficial effect for HRQoL; large beneficial effect for hearing‐specific HRQoL and listening ability).
5Equivalent change calculated assuming a standard deviation of 15.99 in WHO‐DAS II scores in the no hearing aid group.
6Equivalent change calculated assuming a standard deviation of 15.30 in APHAB scores in the no hearing aid group.
7Very serious imprecision as the sample size was very small. There was serious indirectness because only people with mild to moderate Alzheimer's disease were included in the study.

Figures and Tables -
Summary of findings for the main comparison. Hearing aids versus no hearing aids for mild to moderate hearing loss in adults
Comparison 1. Hearing aids versus no/placebo hearing aids

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Hearing‐specific health‐related quality of life Show forest plot

3

722

Mean Difference (IV, Random, 95% CI)

‐26.47 [‐42.16, ‐10.77]

1.1 Subgroup A (community setting, male‐female balance, behind‐the‐ear hearing aids, placebo control)

1

154

Mean Difference (IV, Random, 95% CI)

‐10.54 [‐15.26, ‐5.82]

1.2 Subgroup B (Veterans Association setting, mostly male, in‐the‐ear hearing aids, waiting list control)

2

568

Mean Difference (IV, Random, 95% CI)

‐33.48 [‐36.72, ‐30.23]

2 Health‐related quality of life Show forest plot

2

568

Std. Mean Difference (IV, Random, 95% CI)

‐0.38 [‐0.55, ‐0.21]

2.1 WHO Disability Assessment Schedule 2.0 (WHO‐DAS II, range 0 to 100, lower is better)

1

380

Std. Mean Difference (IV, Random, 95% CI)

‐0.44 [‐0.65, ‐0.24]

2.2 Self‐evaluation of Life Function (SELF, range 54 to 216, lower is better)

1

188

Std. Mean Difference (IV, Random, 95% CI)

‐0.26 [‐0.55, 0.03]

3 Listening ability Show forest plot

2

534

Std. Mean Difference (IV, Random, 95% CI)

‐1.88 [‐3.24, ‐0.52]

3.1 Profile of Hearing Aid Performance (PHAP, range 0 to 1, lower is better)

1

154

Std. Mean Difference (IV, Random, 95% CI)

‐1.18 [‐1.54, ‐0.81]

3.2 Abbreviated Profile of Hearing Aid Benefit (APHAB, range 0 to 100, lower is better)

1

380

Std. Mean Difference (IV, Random, 95% CI)

‐2.57 [‐2.84, ‐2.30]

Figures and Tables -
Comparison 1. Hearing aids versus no/placebo hearing aids