Increasing hearing aid use in infants: contextualisation, development and feasibility testing of an equitable co-designed complex intervention: The RESONATE project.

Background Children need to be immersed in a sound-rich environment for successful speech and language acquisition, socio-emotional development and early learning.

Any degree of hearing loss restricting their exposure to sound can lead to significant speech and language delays; impacting on quality of life (QoL), mental health, socialisation and academic attainment.

Early access to hearing aids (HAs) for deaf infants is critical for development in line with their hearing peers, but benefits of timely intervention cannot be realised without consistent daily use. For very young deaf children, the responsibility of regular HA use falls to their caregiver(s). Evidence suggests 12 hours/day use is optimal, although many families demonstrate difficulties achieving this.

Figures for HA use in young children are nearer to 4-5 hours/day, with some not using them at all.

Research associates parental depression and language barriers, lower maternal education-level and lower socioeconomic opportunity with poorer HA usage. This suggests the existence of unmet practical, social, cultural and internal (PSCI) needs in early audiology care.

Research question Is an equitable co-designed complex intervention aimed to increase HA use in infants acceptable and feasible for use by caregivers and professionals?

Objectives Understand what influences HA usage in infants by exploring associated clinical, cultural and socioeconomic factors.

Produce a two-arm intervention for (1) caregivers and (2) audiology professionals aimed at: Supporting families to achieve optimum HA usage by considering PSCI factors which can impact usage.

Equipping professionals to provide family-centred support that meets the diverse needs of families and the PSCI challenges they face.

Assess the feasibility of a definitive cluster-randomised control trial (CRCT) that evaluates the intervention's effectiveness of increasing HA use in infants.

Methods Study 1 (6 months): A multicentre retrospective records review will be conducted to assess HA use in children aged 0-2 through datalogging values (an objective measurement recorded in the HA and downloaded through software in clinic, calculated as average hours of use per day) against clinical, cultural and socioeconomic factors.

Study 2 (12 months): A behavioural change theory-led participatory co-design approach with caregivers and audiology professionals will be employed. Medical Research Council guidance on creating complex interventions has guided the design.

Through focus groups, we will first contextualise the needs of families and professionals to achieve/support optimal HA use in infants. Secondly, we will design and refine an intervention which can meet their needs.

Study 3 (12 months): A mixed-methods, cluster-randomised control design will be employed to explore the feasibility of a definitive CRCT according to progression criteria.

It considers the practicalities of a CRCT and will allow assessment of the acceptability, equity and utility of the intervention.

Anticipated impact and dissemination This research can have significant short- to long-term effects on audiology services, caregivers and deaf children in terms of equity, QoL and development.

I will publish findings in high-impact academic journals, and present at (inter)national conferences to reach audiology professionals.

Plain language reports will be made available for participants and wider families through social media, audiology departments and schools with deaf units.