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<meta name="citation_keywords" content="Otitis Media with Effusion">
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<meta name="citation_keywords" content="Hearing Loss">
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<meta name="citation_keywords" content="Hearing Aids">
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<meta name="citation_keywords" content="Bone Conduction">
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preserveAspectRatio="none"><path fill="none" stroke="#000" stroke-width="36" stroke-linecap="round" style="fill:#FFF" d="m320,350a153,153 0 1,0-2,2l170,170m-91-117 110,110-26,26-110-110"></path></svg></a><a id="jr-fip-done" class="wsprkl btn" title="Dismiss find">✘</a></nav><nav id="jr-fip-info-p"><a id="jr-fip-prev" class="wsprkl btn" title="Jump to previuos match">◀</a><button id="jr-fip-matches">no matches yet</button><a id="jr-fip-next" class="wsprkl btn" title="Jump to next match">▶</a></nav></nav></div><div id="jr-epub-interstitial" class="hidden"></div><div id="jr-content"><article data-type="main"><div class="main-content lit-style"><div class="fm-sec bkr_bottom_sep"><div class="bkr_thumb"><a href="https://www.nice.org.uk" title="National Institute for Health and Care Excellence (NICE)" class="img_link icnblk_img" ref="pagearea=logo&targetsite=external&targetcat=link&targettype=publisher"><img class="source-thumb" src="/corehtml/pmc/pmcgifs/bookshelf/thumbs/th-niceng233er10-lrg.png" alt="Cover of Evidence reviews for hearing aids/devices for hearing loss associated with OME in children under 12 years" /></a></div><div class="bkr_bib"><h1 id="_NBK595320_"><span itemprop="name">Evidence reviews for hearing aids/devices for hearing loss associated with OME in children under 12 years</span></h1><div class="subtitle">Otitis media with effusion in under 12s</div><p><b>Evidence review J</b></p><p><i>NICE Guideline, No. 233</i></p><div class="half_rhythm">London: <a href="https://www.nice.org.uk" ref="pagearea=meta&targetsite=external&targetcat=link&targettype=publisher"><span itemprop="publisher">National Institute for Health and Care Excellence (NICE)</span></a>; <span itemprop="datePublished">2023 Aug</span>.<div class="small">ISBN-13: <span itemprop="isbn">978-1-4731-5340-0</span></div></div><div><a href="/books/about/copyright/">Copyright</a> © NICE 2023.</div></div><div class="bkr_clear"></div></div><div id="niceng233er10.s1"><h2 id="_niceng233er10_s1_">Hearing aids/devices for hearing loss associated with OME in children under 12 years</h2><div id="niceng233er10.s1.1"><h3>Review question</h3><p>What is the effectiveness of air conduction and bone conduction hearing aids/devices for hearing loss associated with OME in children under 12 years?</p><div id="niceng233er10.s1.1.1"><h4>Introduction</h4><p>The aim of this review is to assess the effectiveness of air conduction and bone conduction hearing aids/devices for hearing loss associated with OME in children under 12 years.</p></div><div id="niceng233er10.s1.1.2"><h4>Summary of the protocol</h4><p>See <a class="figpopup" href="/books/NBK595320/table/niceng233er10.tab1/?report=objectonly" target="object" rid-figpopup="figniceng233er10tab1" rid-ob="figobniceng233er10tab1">Table 1</a> for a summary of the Population, Intervention, Comparison and Outcome (PICO) characteristics of this review.</p><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng233er10tab1"><a href="/books/NBK595320/table/niceng233er10.tab1/?report=objectonly" target="object" title="Table 1" class="img_link icnblk_img figpopup" rid-figpopup="figniceng233er10tab1" rid-ob="figobniceng233er10tab1"><img class="small-thumb" src="/books/NBK595320/table/niceng233er10.tab1/?report=thumb" src-large="/books/NBK595320/table/niceng233er10.tab1/?report=previmg" alt="Table 1. Summary of the protocol (PICO table)." /></a><div class="icnblk_cntnt"><h4 id="niceng233er10.tab1"><a href="/books/NBK595320/table/niceng233er10.tab1/?report=objectonly" target="object" rid-ob="figobniceng233er10tab1">Table 1</a></h4><p class="float-caption no_bottom_margin">Summary of the protocol (PICO table). </p></div></div><p>For further details see the review protocol in <a href="#niceng233er10.appa">appendix A</a>.</p></div><div id="niceng233er10.s1.1.3"><h4>Methods and process</h4><p>This evidence review was developed using the methods and process described in <a href="https://www.nice.org.uk/process/pmg20/chapter/introduction" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Developing NICE guidelines: the manual</a>. Methods specific to this review question are described in the review protocol in <a href="#niceng233er10.appa">appendix A</a> and the <a href="/books/NBK595320/bin/NG233_supplement_1_Methods_20230830.pdf">methods</a> document (supplementary document 1).</p><p>Declarations of interest were recorded according to <a href="https://www.nice.org.uk/about/who-we-are/policies-and-procedures" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">NICE’s conflicts of interest policy</a>.</p></div><div id="niceng233er10.s1.1.4"><h4>Effectiveness evidence</h4><div id="niceng233er10.s1.1.4.1"><h5>Included studies</h5><p>A systematic review of the literature was conducted but no studies were identified which were applicable to this review question.</p><p>See the literature search strategy in <a href="#niceng233er10.appb">appendix B</a> and study selection flow chart in <a href="#niceng233er10.appc">appendix C</a>.</p></div><div id="niceng233er10.s1.1.4.2"><h5>Excluded studies</h5><p>Studies not included in this review are listed, and reasons for their exclusion are provided in <a href="#niceng233er10.appj">appendix J</a>.</p></div></div><div id="niceng233er10.s1.1.5"><h4>Summary of included studies</h4><p>No studies were identified which were applicable to this review question (and so there are no evidence tables in <a href="#niceng233er10.appd">Appendix D</a>). No meta-analysis was conducted for this review (and so there are no forest plots in <a href="#niceng233er10.appe">Appendix E</a>).</p></div><div id="niceng233er10.s1.1.6"><h4>Summary of the evidence</h4><p>No studies were identified which were applicable to this review question (and so there are no GRADE tables in <a href="#niceng233er10.appf">Appendix F</a>).</p></div><div id="niceng233er10.s1.1.7"><h4>Economic evidence</h4><div id="niceng233er10.s1.1.7.1"><h5>Included studies</h5><p>A systematic review of the economic literature was conducted but no economic studies were identified which were applicable to this review question.</p></div></div><div id="niceng233er10.s1.1.8"><h4>Economic model</h4><p>An economic model was undertaken which compared hearing aids, ventilation tubes and ventilation tubes with adjuvant adenoidectomy in children with hearing loss associated with OME. This model is discussed in Evidence review E.</p></div><div id="niceng233er10.s1.1.9"><h4>The committee’s discussion and interpretation of the evidence</h4><div id="niceng233er10.s1.1.9.1"><h5>The outcomes that matter most</h5><p>Hearing loss or hearing difficulty is often associated with OME, and this could impact on the child’s development. As the primary aim of hearing aids and devices is to improve hearing, hearing was prioritised as a critical outcome. Quality of life was also prioritised as a critical outcome as this is a global measure that takes into account both beneficial and adverse effects of the interventions. Difficulty with speech discrimination is common when hearing is impaired and therefore may be affected by hearing aids. Therefore, speech discrimination was also prioritised as a critical outcome.</p><p>Hearing loss can also lead to impairment of listening skills (for example, turning to sounds and voices, listening to stories attentively, following instructions) and receptive language skills, which can impact children’s development and education. Similarly, psychosocial development may be affected if they have difficulty communicating with others. Due to the importance of these outcomes for children’s development and the likelihood of them being affected by hearing aids, these were selected as important outcomes. Although hearing aids and devices may improve hearing, speech, language, and behavioural development in children with OME, children may not tolerate such devices or may not want to wear such devices. The overall ability and willingness of children to use such devices is important and this may depend on the type of hearing aid or device used. Therefore, acceptability was also selected as an important outcome.</p></div><div id="niceng233er10.s1.1.9.2"><h5>The quality of the evidence</h5><p>No studies were identified which were applicable to this review question.</p></div><div id="niceng233er10.s1.1.9.3"><h5>Benefits and harms</h5><p>There was no available evidence which was applicable to this review question on the effectiveness of air conduction and bone conduction hearing aids/devices for hearing loss associated with OME in children under 12 years. Therefore, the committee made recommendations based on current practice and their knowledge and expert opinion.</p><p>The committee acknowledged that there is high prevalence of OME in children, and the main aim of the management of hearing loss associated with OME is to minimise the negative impacts on children’s learning, development and quality of life. The committee discussed that children with hearing loss associated with OME may hear many sounds around them, but they may be muffled and unclear, which may have impact on early speech and language development. In the committee’s expert knowledge and experience, air conduction hearing aids and bone conduction devices may improve development in terms of hearing, wellbeing, behaviour, speech and language, and these devices may be effective for both new onset and chronic OME. Therefore, the committee agreed that these devices should be considered in children with OME-related hearing loss.</p><p>The committee discussed the indications for bone conduction devices and air conduction hearing aids. The committee were aware that air conduction hearing aids tend to offer better noise reduction, signal processing and connectivity features than current models of bone conduction hearing aids. These features may provide improved speech clarity and overall sound quality. However, when hearing levels change or fluctuate, air conduction hearing aids may need to be adjusted which would usually require an additional appointment, impacting families and requiring additional resources. Bone conduction devices do not require this adjustment for changes to hearing levels. In addition, in children with a history of recurrent or persistent otorrhoea, air conduction hearing aids may not be suitable because hearing aids can exacerbate otorrhoea, and otorrhoea can damage or occlude air conduction hearing aids, rendering them ineffective. Similarly, air conduction hearing aids may not be suitable for children with anatomical issues such as narrow ear canals, due to difficulty in inserting the hearing aid or increased likelihood of wax occlusion. The committee also acknowledged that air conduction hearing aids and their components are more likely to be choking hazards when compared with bone conduction devices, particularly for children with learning disabilities, because of smaller parts on air conduction hearing aids, which are easier to take apart. However, bone conduction devices tend to have an obvious headband and are therefore less discrete than air conduction hearing aids, which may not be acceptable to some children or their families. Therefore, air conduction hearing aids may be considered more suitable when hearing loss does not fluctuate and such a device is preferred or tolerated, and bone conduction hearing aids may be considered more suitable when hearing levels are known to fluctuate or there are contraindications to air conduction hearing aids as outlined above. The committee agreed that it can be difficult to decide what types of hearing aids or devices are more appropriate for individual children, so it was important to make recommendations about the indications and contraindications for the two different types to help aid decision making.</p><p>The committee recognised the risk of button batteries in hearing aids and hearing devices. Young children and children with learning difficulties might put things such as button batteries into their mouths; if ingested, button batteries pose a significant risk of harm to children, including tissue necrosis, perforation, haemorrhage, or death. Although the safety of hearing aids was outside the scope of this review and is not specific to children with OME, the committee agreed it was important to raise awareness of the risk of button batteries in hearing aids and hearing devices as it is an important safety issue that may be of particular concern for the population of this guideline due to their young age and the higher prevalence of OME among people with learning difficulties. Further, in the committee’s experience, parents are not always alerted to the risk of button batteries. Therefore, the committee agreed to include a cross-reference to the NHS national patient safety alert on risk of harm to babies and children from coin/button batteries in hearing aids and other hearing devices (<a class="bibr" href="#niceng233er10.s1.ref1" rid="niceng233er10.s1.ref1">NHS England 2019</a>).</p><p>Based on their knowledge and experience, the committee acknowledged that the use of air conduction and bone conduction hearing aids/devices is a common practice for managing OME-related hearing loss. As the primary aim of providing interventions for OME is to minimise negative impacts of hearing loss on the child’s development and quality of life, interventions need to be effective in supporting hearing. In addition, interventions should be suitable and acceptable for children and their carers so that there is good uptake and cost-effectiveness. However, there is no available evidence to inform the clinical and costeffectiveness of air conduction and bone conduction hearing aids/devices for hearing loss associated with OME in children under 12 years. Therefore, the committee made a research recommendation about it (see <a href="#niceng233er10.appk">Appendix K</a>).</p></div><div id="niceng233er10.s1.1.9.4"><h5>Cost effectiveness and resource use</h5><p>These guideline recommendations have the potential both to increase costs and produce savings, but these are unlikely to be substantial and the extent of any increase in cost or saving will depend on the implementation of the guidance as they are mostly “consider” recommendations.</p><p>Compared to existing guidance, these recommendations make the provision of hearing aids for new or short-term hearing loss more permissive, and this could increase costs. However, as the guideline gives more scope to provide hearing aids as an alternative to ventilation tubes, this may reduce inpatient stays and costs associated with surgery. Furthermore, especially for children with learning disabilities, earlier intervention may have a positive impact on development and behaviour which then has the potential to reduce “downstream” costs. An economic model developed for this guideline suggested that hearing aids had comparable cost-effectiveness to surgical alternatives in children under 12 years with hearing loss associated with OME. In the base case probabilistic analysis, the incremental costeffectiveness ratio (ICER) for hearing aids was £20,475 relative to no intervention. Hearing aids had the highest net monetary benefit in that analysis of the interventions and a 21% probability of being the most cost-effective option (no intervention 10%; ventilation tubes 27%, ventilation tubes with adjuvant adenoidectomy 42%). Sensitivity analysis also indicated that the model conclusions were sensitive to many model inputs and considerable uncertainty remains with respect to the relative cost-effectiveness of hearing aids and surgical alternatives for hearing loss associated with OME.</p><p>The cost of a bone conduction device is considerably higher than for an air conduction device, but the committee noted that this would be offset to some extent by non-device costs which are higher for air conduction hearing aids. The number of children with narrow ear canals is small and therefore any increased use of bone conduction devices in this group is unlikely to lead to a significant increase in costs.</p></div></div><div id="niceng233er10.s1.1.10"><h4>Recommendations supported by this evidence review</h4><p>This evidence review supports recommendations 1.4.1 – 1.4.4 and the research recommendation on the effectiveness of air conduction and bone conduction hearing aids/devices for hearing loss associated with OME in children under 12 years.</p></div></div><div id="niceng233er10.s1.rl.r1"><h3>References – included studies</h3><ul class="simple-list"><div id="niceng233er10.s1.rl.r1.1"><h4>Other</h4><ul class="simple-list"><li class="half_rhythm"><p><div class="bk_ref" id="niceng233er10.s1.ref1"><p id="p-46">
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<strong>NHS England 2019</strong>
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</p>National Health Service England (2019). Risk of harm to babies and children from coin/button batteries in hearing aids and other hearing devices. Available at: <a href="https://www.england.nhs.uk/wp-content/uploads/2020/02/NatPSA_hearing_aid_batteries_December_2019_FINAL.pdf" ref="pagearea=cite-ref&targetsite=external&targetcat=link&targettype=uri">https://www<wbr style="display:inline-block"></wbr>​.england.nhs<wbr style="display:inline-block"></wbr>​.uk/wp-content/uploads<wbr style="display:inline-block"></wbr>​/2020/02/NatPSA<wbr style="display:inline-block"></wbr>​_hearing_aid_batteries<wbr style="display:inline-block"></wbr>​_December_2019_FINAL.pdf</a> [Accessed 10/08/2022]</div></p></li></ul></div></ul></div></div><div id="appendixesappgroup1"><h2 id="_appendixesappgroup1_">Appendices</h2><div id="niceng233er10.appa"><h3>Appendix A. Review protocols</h3><p id="niceng233er10.appa.et1"><a href="/books/NBK595320/bin/niceng233er10-appa-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Review protocol for review question: What is the effectiveness of air conduction and bone conduction hearing aids/devices for hearing loss associated with OME in children under 12 years?</a><span class="small"> (PDF, 244K)</span></p></div><div id="niceng233er10.appb"><h3>Appendix B. Literature search strategies</h3><p id="niceng233er10.appb.et1"><a href="/books/NBK595320/bin/niceng233er10-appb-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Literature search strategies for review question: What is the effectiveness of air conduction and bone conduction hearing aids/devices for hearing loss associated with OME in children under 12 years?</a><span class="small"> (PDF, 143K)</span></p></div><div id="niceng233er10.appc"><h3>Appendix C. Effectiveness evidence study selection</h3><p id="niceng233er10.appc.et1"><a href="/books/NBK595320/bin/niceng233er10-appc-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Study selection for: What is the effectiveness of air conduction and bone conduction hearing aids/devices for hearing loss associated with OME in children under 12 years?</a><span class="small"> (PDF, 195K)</span></p></div><div id="niceng233er10.appd"><h3>Appendix D. Evidence tables</h3><div id="niceng233er10.appd.s1"><h4>Evidence tables for review question: What is the effectiveness of air conduction and bone conduction hearing aids/devices for hearing loss associated with OME in children under 12 years?</h4><p>No evidence was identified which was applicable to this review question.</p></div></div><div id="niceng233er10.appe"><h3>Appendix E. Forest plots</h3><div id="niceng233er10.appe.s1"><h4>Forest plots for review question: What is the effectiveness of air conduction and bone conduction hearing aids/devices for hearing loss associated with OME in children under 12 years?</h4><p>No meta-analysis was conducted for this review question and so there are no forest plots.</p></div></div><div id="niceng233er10.appf"><h3>Appendix F. GRADE tables</h3><div id="niceng233er10.appf.s1"><h4>GRADE tables for review question: What is the effectiveness of air conduction and bone conduction hearing aids/devices for hearing loss associated with OME in children under 12 years?</h4><p>No evidence was identified which was applicable to this review question.</p></div></div><div id="niceng233er10.appg"><h3>Appendix G. Economic evidence study selection</h3><p id="niceng233er10.appg.et1"><a href="/books/NBK595320/bin/niceng233er10-appg-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Study selection for: What is the effectiveness of air conduction and bone conduction hearing aids/devices for hearing loss associated with OME in children under 12 years?</a><span class="small"> (PDF, 179K)</span></p></div><div id="niceng233er10.apph"><h3>Appendix H. Economic evidence tables</h3><div id="niceng233er10.apph.s1"><h4>Economic evidence tables for review question: What is the effectiveness of air conduction and bone conduction hearing aids/devices for hearing loss associated with OME in children under 12 years?</h4><p>No evidence was identified which was applicable to this review question.</p></div></div><div id="niceng233er10.appi"><h3>Appendix I. Economic model</h3><div id="niceng233er10.appi.s1"><h4>Economic model for review question: What is the effectiveness of air conduction and bone conduction hearing aids/devices for hearing loss associated with OME in children under 12 years?</h4><p>An economic model was undertaken which compared hearing aids, ventilation tubes and ventilation tubes with adjuvant adenoidectomy in children with hearing loss associated with OME. This model is discussed in Evidence review E.</p></div></div><div id="niceng233er10.appj"><h3>Appendix J. Excluded studies</h3><div id="niceng233er10.appj.s1"><h4>Excluded studies for review question: What is the effectiveness of air conduction and bone conduction hearing aids/devices for hearing loss associated with OME in children under 12 years?</h4><div id="niceng233er10.appj.s1.1"><h5>Excluded effectiveness studies</h5><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng233er10appjtab1"><a href="/books/NBK595320/table/niceng233er10.appj.tab1/?report=objectonly" target="object" title="Table 3" class="img_link icnblk_img figpopup" rid-figpopup="figniceng233er10appjtab1" rid-ob="figobniceng233er10appjtab1"><img class="small-thumb" src="/books/NBK595320/table/niceng233er10.appj.tab1/?report=thumb" src-large="/books/NBK595320/table/niceng233er10.appj.tab1/?report=previmg" alt="Table 3. Excluded studies and reasons for their exclusion Study Code [Reason]." /></a><div class="icnblk_cntnt"><h4 id="niceng233er10.appj.tab1"><a href="/books/NBK595320/table/niceng233er10.appj.tab1/?report=objectonly" target="object" rid-ob="figobniceng233er10appjtab1">Table 3</a></h4><p class="float-caption no_bottom_margin">Excluded studies and reasons for their exclusion Study Code [Reason]. </p></div></div></div><div id="niceng233er10.appj.s1.2"><h5>Excluded economic studies</h5><p>No economic evidence was identified for this review.</p></div></div></div><div id="niceng233er10.appk"><h3>Appendix K. Research recommendations – full details</h3><p id="niceng233er10.appk.et1"><a href="/books/NBK595320/bin/niceng233er10-appk-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Research recommendations for review question: What is the effectiveness of air conduction and bone conduction hearing aids/devices for hearing loss associated with OME in children under 12 years?</a><span class="small"> (PDF, 145K)</span></p></div></div></div><div class="fm-sec"><div><p>Final</p></div><div><p>Evidence reviews underpinning recommendations 1.4.1 to 1.4.4 and research recommendation in the NICE guideline</p><p>This evidence review was developed by NICE</p></div><div><p><b>Disclaimer</b>: The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.</p><p>Local commissioners and/or providers have a responsibility to enable the guideline to be applied when individual health professionals and their patients or service users wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with compliance with those duties.</p><p>NICE guidelines cover health and care in England. Decisions on how they apply in other UK countries are made by ministers in the <a href="http://wales.gov.uk/" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Welsh Government</a>, <a href="http://www.scotland.gov.uk/" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Scottish Government</a>, and <a href="http://www.northernireland.gov.uk/" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Northern Ireland Executive</a>. All NICE guidance is subject to regular review and may be updated or withdrawn.</p></div><div class="half_rhythm"><a href="/books/about/copyright/">Copyright</a> © NICE 2023.</div><div class="small"><span class="label">Bookshelf ID: NBK595320</span><span class="label">PMID: <a href="https://pubmed.ncbi.nlm.nih.gov/37792984" title="PubMed record of this title" ref="pagearea=meta&targetsite=entrez&targetcat=link&targettype=pubmed">37792984</a></span></div></div><div class="small-screen-prev"></div><div class="small-screen-next"></div></article><article data-type="table-wrap" id="figobniceng233er10tab1"><div id="niceng233er10.tab1" class="table"><h3><span class="label">Table 1</span><span class="title">Summary of the protocol (PICO table)</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK595320/table/niceng233er10.tab1/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng233er10.tab1_lrgtbl__"><table><tbody><tr><th id="hd_b_niceng233er10.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Population</th><td headers="hd_b_niceng233er10.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">All children under 12 years with hearing loss due to confirmed otitis media with effusion</td></tr><tr><th id="hd_b_niceng233er10.tab1_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Intervention</th><td headers="hd_b_niceng233er10.tab1_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<ul><li class="half_rhythm"><div>Air conduction hearing aid/device</div></li><li class="half_rhythm"><div>Bone conduction hearing aid/device</div></li><li class="half_rhythm"><div>Unspecified hearing aid/device</div></li></ul>
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</td></tr><tr><th id="hd_b_niceng233er10.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Comparison</th><td headers="hd_b_niceng233er10.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<ul><li class="half_rhythm"><div>Head-to-head comparisons between the interventions</div></li><li class="half_rhythm"><div>No hearing aid/device</div></li></ul>
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</td></tr><tr><th id="hd_b_niceng233er10.tab1_1_1_4_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Outcome</th><td headers="hd_b_niceng233er10.tab1_1_1_4_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"><p><b>Critical</b>
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<ul><li class="half_rhythm"><div>Hearing (measured by pure tone audiometry or speech recognition thresholds, in dB HL)</div></li><li class="half_rhythm"><div>Quality of life (measured by OM8-30 questionnaire, Health Utilities Index Mark 3 (HUI3) questionnaire, Otitis Media-6 (OM-6) questionnaire, Quality of Life in Children’s Ear Problems (OMQ-14) questionnaire, Evaluation of Children’s Listening and Processing Skills (ECLiPS) questionnaire, Auditory Behaviour in Everyday Life (ABEL) questionnaire, Early Listening Function (ELF) questionnaire, Parents’ Evaluation of Aural/Oral Performance of Children (PEACH) questionnaire, EuroQol 5 Dimensions (EQ-5D) questionnaire, Infant Toddler Quality of Life Questionnaire, or Child Heath Questionnaire)</div></li><li class="half_rhythm"><div>Speech discrimination (measured by the McCormick Toy Test and the Manchester Picture Test)</div></li></ul></p>
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<p><b>Important</b>
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<ul><li class="half_rhythm"><div>Listening skills (for example, turning to sounds and voices, listening stories attentively, following instructions)</div></li><li class="half_rhythm"><div>Receptive language skills (measured by Peabody-revised picture vocabulary test or the relevant domains of the Reynell Developmental Language Scales, Preschool Language Scale (PLS), or Sequenced Inventory of Communication Development (SICD))</div></li><li class="half_rhythm"><div>Psychosocial development (measured by the Social Skills Scale of the Social Skills Rating System or validated measures of self-esteem, confidence and peer and family relationships)</div></li><li class="half_rhythm"><div>Acceptability</div></li></ul></p></td></tr></tbody></table></div></div></article><article data-type="table-wrap" id="figobniceng233er10appjtab1"><div id="niceng233er10.appj.tab1" class="table"><h3><span class="label">Table 3</span><span class="title">Excluded studies and reasons for their exclusion Study Code [Reason]</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK595320/table/niceng233er10.appj.tab1/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng233er10.appj.tab1_lrgtbl__"><table><thead><tr><th id="hd_h_niceng233er10.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Study</th><th id="hd_h_niceng233er10.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Code [Reason]</th></tr></thead><tbody><tr><td headers="hd_h_niceng233er10.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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Arick, Daniel S and Silman, Shlomo (2005) Nonsurgical home treatment of middle ear effusion and associated hearing loss in children. Part I: clinical trial. Ear, nose, & throat journal
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84(9): 567-passim [<a href="https://pubmed.ncbi.nlm.nih.gov/16261757" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 16261757</span></a>]
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</td><td headers="hd_h_niceng233er10.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>- Intervention not in PICO</p>
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<p>
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<i>Modified Politzer device/air into nostrils</i>
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</p>
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</td></tr><tr><td headers="hd_h_niceng233er10.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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Arman, S.; Amlani, A.; Doshi, J. (2020) Glue ear management & deprivation-A retrospective study of 89 patients. Clinical Otolaryngology
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45(4): 616–618 [<a href="https://pubmed.ncbi.nlm.nih.gov/32248645" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 32248645</span></a>]
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</td><td headers="hd_h_niceng233er10.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>- Analyses not in PICO</p>
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<p>
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<i>N5/73 had hearing aids; all comparative analyses examined effect of deprivation</i>
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</p>
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</td></tr><tr><td headers="hd_h_niceng233er10.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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Banigo, A, Hunt, A, Rourke, T
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et al. (2016) Does the EarPopper( R) device improve hearing outcomes in children with persistent otitis media with effusion? A randomised single-blinded controlled trial. Clinical otolaryngology : official journal of ENT-UK ; official journal of Netherlands Society for Oto-Rhino-Laryngology & Cervico-Facial Surgery
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41(1): 59–65 [<a href="https://pubmed.ncbi.nlm.nih.gov/26095773" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 26095773</span></a>]
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</td><td headers="hd_h_niceng233er10.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>- Intervention not in PICO</p>
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<p>
|
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<i>Modified Politzer/Ear popper device/air into nostrils</i>
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</p>
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</td></tr><tr><td headers="hd_h_niceng233er10.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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Cambridgeshire Community Services NHS, Trust (2020) Exploring Interventions for Glue Ear During Covid-19. <a href="http://clinicaltrials.gov" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">clinicaltrials<wbr style="display:inline-block"></wbr>​.gov</a>
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</td><td headers="hd_h_niceng233er10.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Non-comparative study</td></tr><tr><td headers="hd_h_niceng233er10.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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Gani, Bilal; Kinshuck, A J; Sharma, R (2012) A review of hearing loss in cleft palate patients. International journal of otolaryngology
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2012: 548698 [<a href="/pmc/articles/PMC3299272/" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC3299272</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/22518157" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 22518157</span></a>]
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</td><td headers="hd_h_niceng233er10.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Analyses not in PICO</td></tr><tr><td headers="hd_h_niceng233er10.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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Hall, A, Wills, A K, Mahmoud, O
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et al. (2017) Centre-level variation in outcomes and treatment for otitis media with effusion and hearing loss and the association of hearing loss with developmental outcomes at ages 5 and 7 years in children with non-syndromic unilateral cleft lip and palate: The Cleft Care UK study. Part 2. Orthodontics & craniofacial research
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20suppl2: 8–18 [<a href="https://pubmed.ncbi.nlm.nih.gov/28661080" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 28661080</span></a>]
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</td><td headers="hd_h_niceng233er10.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Analyses not in PICO</td></tr><tr><td headers="hd_h_niceng233er10.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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Holland Brown, Tamsin, Salorio-Corbetto, Marina, Gray, Roger
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et al. (2019) Using a Bone-Conduction Headset to Improve Speech Discrimination in Children With Otitis Media With Effusion. Trends in hearing
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23: 2331216519858303 [<a href="/pmc/articles/PMC6716182/" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC6716182</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/31464177" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 31464177</span></a>]
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</td><td headers="hd_h_niceng233er10.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>- Analyses not in PICO</p>
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<p><i>N=19, all received same intervention [bone-conduction headset]. Analyses examined different conditions within each participant</i>.</p>
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</td></tr><tr><td headers="hd_h_niceng233er10.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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Homøe, P, Heidemann, CH, Damoiseaux, RA
|
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et al. (2020) Panel 5: Impact of otitis media on quality of life and development. International journal of pediatric otorhinolaryngology
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130suppl1: 109837 [<a href="/pmc/articles/PMC7197055/" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC7197055</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/31883704" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 31883704</span></a>]
|
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</td><td headers="hd_h_niceng233er10.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Systematic review, included studies checked for relevance</td></tr><tr><td headers="hd_h_niceng233er10.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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Maheshwar, A A, Milling, M A P, Kumar, M
|
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et al. (2002) Use of hearing aids in the management of children with cleft palate. International journal of pediatric otorhinolaryngology
|
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66(1): 55–62 [<a href="https://pubmed.ncbi.nlm.nih.gov/12363423" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 12363423</span></a>]
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</td><td headers="hd_h_niceng233er10.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
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<p>- Outcome not in PICO</p>
|
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<p>
|
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<i>Potentially relevant outcomes not clearly defined or reported; non-randomised study with n=17/70 receiving hearing aids only, 12/70 ventilation tubes only, 14/70 hearing aids + ventilation tubes and 27/70 no treatment; unclear inclusion criteria in terms of hearing and OME status “Between 1984 and 1998, 135 children with cleft lip, cleft palate or a combination of both were operated in the Gwent area, and were followed up in this clinic. We have carried out a retrospective study of the otological management of these children. Children with cleft lips only, sub mucosal cleft palates, patients who have moved to other areas, are deceased and those patients who defaulted were excluded from the study.” (p. 56)</i>
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</p>
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</td></tr><tr><td headers="hd_h_niceng233er10.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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Mohiuddin, Syed, Payne, Katherine, Fenwick, Elisabeth
|
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et al. (2015) A model-based cost-effectiveness analysis of a grommets-led care pathway for children with cleft palate affected by otitis media with effusion. The European journal of health economics : HEPAC : health economics in prevention and care
|
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16(6): 573–87 [<a href="https://pubmed.ncbi.nlm.nih.gov/24906214" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 24906214</span></a>]
|
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</td><td headers="hd_h_niceng233er10.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Health-economic analysis, no original clinical data</td></tr><tr><td headers="hd_h_niceng233er10.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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NHS Centre for Reviews and, Dissemination (1992) The treatment of persistent glue ear in children.
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</td><td headers="hd_h_niceng233er10.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
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<p>- Intervention not in PICO</p>
|
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<p>
|
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<i>Surgical interventions</i>
|
|
</p>
|
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</td></tr><tr><td headers="hd_h_niceng233er10.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
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Parrella, A, Hiller, J
|
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et al. (2005) EarPopper (TM) for the treatment of otitis media with effusion in children.
|
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</td><td headers="hd_h_niceng233er10.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
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<p>- Intervention not in PICO</p>
|
|
<p>
|
|
<i>Modified Politzer/Ear popper device/air into nostrils</i>
|
|
</p>
|
|
</td></tr><tr><td headers="hd_h_niceng233er10.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
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Qureishi, A, Garas, G, Mallick, A
|
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et al. (2014) The psychosocial impact of hearing aids in children with otitis media with effusion. The Journal of laryngology and otology
|
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128(11): 972–5 [<a href="https://pubmed.ncbi.nlm.nih.gov/25274185" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 25274185</span></a>]
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</td><td headers="hd_h_niceng233er10.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
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<p>- Outcome not in PICO</p>
|
|
<p>
|
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<i>Questionnaire regarding the parents of children who have either received grommets or hearing aids about their perception of hearing aids, thus the parents of the children with grommets have not had any actual experience of hearing aids; non-randomised study.</i>
|
|
</p>
|
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</td></tr><tr><td headers="hd_h_niceng233er10.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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Ramakrishnan, Y; Davison, T; Johnson, I J M (2006) How we do it: Softband--management of glue ear. Clinical otolaryngology : official journal of ENT-UK; official journal of Netherlands Society for Oto-Rhino-Laryngology & Cervico-Facial Surgery
|
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31(3): 224–7 [<a href="https://pubmed.ncbi.nlm.nih.gov/16759246" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 16759246</span></a>]
|
|
</td><td headers="hd_h_niceng233er10.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Non-comparative study</td></tr><tr><td headers="hd_h_niceng233er10.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
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Ramakrishnan, Y, Marley, S, Leese, D
|
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et al. (2011) Bone-anchored hearing aids in children and young adults: the Freeman Hospital experience. The Journal of laryngology and otology
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125(2): 153–7 [<a href="https://pubmed.ncbi.nlm.nih.gov/20849670" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 20849670</span></a>]
|
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</td><td headers="hd_h_niceng233er10.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
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<p>- Analyses not in PICO</p>
|
|
<p>
|
|
<i>Population received either bone-anchored hearing aids (mean age 16.1 years) or softband (mean age 8.4); analyses either descriptive or focused on syndrome/non-syndrome comparison</i>
|
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</p>
|
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</td></tr><tr><td headers="hd_h_niceng233er10.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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Sait, Salam; Alamoudi, Sarah; Zawawi, Faisal (2022) Management outcomes of otitis media with effusion in children with down syndrome: A systematic review. International journal of pediatric otorhinolaryngology
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156: 111092 [<a href="https://pubmed.ncbi.nlm.nih.gov/35290945" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 35290945</span></a>]
|
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</td><td headers="hd_h_niceng233er10.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Systematic review, included studies checked for relevance</td></tr><tr><td headers="hd_h_niceng233er10.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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Schilder, A.G.M., Marom, T., Bhutta, M.F.
|
|
et al. (2017) Panel 7: Otitis Media: Treatment and Complications. Otolaryngology - Head and Neck Surgery (United States)
|
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156(4suppl): 88–s105 [<a href="https://pubmed.ncbi.nlm.nih.gov/28372534" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 28372534</span></a>]
|
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</td><td headers="hd_h_niceng233er10.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Systematic review, included studies checked for relevance</td></tr><tr><td headers="hd_h_niceng233er10.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Shohet, J.A.; Gende, D.M.; Tanita, C.S. (2018) Totally implantable active middle ear implant: Hearing and safety results in a large series. Laryngoscope
|
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128(12): 2872–2878 [<a href="https://pubmed.ncbi.nlm.nih.gov/30194720" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 30194720</span></a>]
|
|
</td><td headers="hd_h_niceng233er10.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
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<p>- Population not in PICO</p>
|
|
<p>
|
|
<i>Adults</i>
|
|
</p>
|
|
</td></tr><tr><td headers="hd_h_niceng233er10.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Silman, Shlomo; Arick, Daniel S; Emmer, Michele B (2005) Nonsurgical home treatment of middle ear effusion and associated hearing loss in children. Part II: Validation study. Ear, nose, & throat journal
|
|
84(10): 646-passim [<a href="https://pubmed.ncbi.nlm.nih.gov/16382747" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 16382747</span></a>]
|
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</td><td headers="hd_h_niceng233er10.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>- Intervention not in PICO</p>
|
|
<p>
|
|
<i>Modified Politzer device/air into nostrils</i>
|
|
</p>
|
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