A/Prof. Valerie Sung1,2,3, Dr Teresa Y.C. Ching4,5,6, Ms Libby Smith1, Ms Vivienne Marnane7, Ms Alison King8, Dr Rachael Beswick9, Dr Claire Iseli2,3, Dr Peter Carew1,3
1Murdoch Children’s Research Institute, Parkville, Australia, 2Royal Children’s Hospital, Parkville, Australia, 3University of Melbourne, Parkville, Australia, 4NextSense Institute, Sydney, Australia, 5Macquarie University, Sydney, Australia, 6University of Queensland, St Lucia, Australia, 7National Acoustic Laboratories, Sydney, Australia, 8Hearing Australia, Box Hill, Australia, 9Children’s Health Queensland Hospital and Health Service, South Brisbane, Australia
Early identification of mild hearing loss has resulted in early hearing amplification. This proof-of-concept randomised controlled trial (RCT) of hearing device fitting versus no fitting aimed to gather preliminary data on language, social abilities, functional performance and listening effort, and determine the RCT’s acceptability/feasibility in children <2 years old with bilateral mild hearing loss.
Of 40 potentially eligible families, nine (23%) declined, three uncontactable (7%), 26 (65%) ineligible: of these, nine (35%) did not meet hearing threshold inclusion criteria, 11 (42%) were already fitted or had made decisions on fitting hearing device, two (7%) had conductive loss and four (16%) had other reasons. Two of 11 (18%) eligible families were randomised. With the limited sample size, outcome measures were not compared between groups.
To understand the barriers/enablers to RCT participation, we completed interviews with 10 parents and 10 audiologists. The decision that a parent would ultimately make was the result of a complex interplay of a) individual circumstances and beliefs, b) study design, c) perceived benefits and d) costs of participation. Parents have to cope with additional decision-making processes around amplification and research participation is an extra decision-making process. Many parents have perceived preferences of whether their child should have hearing aids. Randomization is a barrier, as it takes away parental control over whether their child could be fitted with hearing aids, with some fearing subsequent regret for not fitting.
Our study highlighted the challenging nature of diagnosing mild bilateral hearing loss early. Barriers to recruitment that may be difficult to modify included parents’ early views/decisions regarding amplification, especially fear of subsequent regret for not fitting hearing aids, and the fear of loss of control during the process of randomization. Alternative methodological approaches without randomization may be required to determine whether hearing amplification benefits infants with mild hearing loss.
Biography:
A/Prof Valerie Sung is a paediatrician and director of the Caring for Hearing In Children Clinic at the Royal Children’s Hospital, and leads a hearing loss health services research group at the Murdoch Children’s Research Institute to identify early predictors of child outcomes and establish evidence-based management through population and clinical cohorts as well as intervention trials. Valerie chairs the Childhood Hearing Australasian Medical Professionals (CHAMP) Network which developed national guidelines for managing childhood hearing loss. She is a committee member of the Australian Newborn Hearing Screening Committee, and editorial panel member of the Journal of Paediatrics and Child Health.