Evidence reviews for hearing aids/devices for hearing loss associated with OME in children under 12 years

Included studies

A systematic review of the literature was conducted but no studies were identified which were applicable to this review question.

See the literature search strategy in appendix B and study selection flow chart in appendix C.

Excluded studies

Studies not included in this review are listed, and reasons for their exclusion are provided in appendix J.

Included studies

A systematic review of the economic literature was conducted but no economic studies were identified which were applicable to this review question.

The outcomes that matter most

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.

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.

The quality of the evidence

No studies were identified which were applicable to this review question.

Benefits and harms

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.

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.

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.

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 (NHS England 2019).

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 Appendix K).

Cost effectiveness and resource use

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.

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.

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.

Excluded effectiveness studies

Table 3

Excluded studies and reasons for their exclusion Study Code [Reason].

Excluded economic studies

No economic evidence was identified for this review.