SRS82 Patey Prize Entrant - A randomised prospective placebo-controlled cross-over study of the acceptability and efficacy of bone conduction assistive technology for school-age children with hearing impairment in Blantyre Malawi

Background Literature suggests a high hearing burden for children in low-resource settings, with a reported prevalence of almost 25% in Malawi. Future studies need to verify these figures in epidemiological surveys and trial new methods of treating hearing loss where technological and surgical provision is insufficient. Methods A cross-sectional study of hearing in all children aged 5–16years attending four participating schools. Identified children then received treatment in two(active and placebo) 8-week periods, of a novel bone conduction headset to treat their hearing loss. The primary outcome was the between-treatment difference in the Digits-in-Noise(DIN) score, versus baseline, during each period. Key secondary outcomes explored quality-of-life. Results 1600 children were invited to participate. 817 were assessed, of these 254(31%) children had a self-reported hearing impairment. Of those with hearing impairment, only seven children reported prior hearing-aid use. Only 20 children completed 8 weeks in both arms. The primary outcome did not significantly increase (−7.5 (IQR 6.25)) versus the children’s median baseline score (−11 (3.5) P = 0.78). Only one secondary outcome (the self-acceptance score) improved significantly with active device. Discussion This trial of a frugal hearing device in a school setting was achievable with exploratory analyses suggesting safety and acceptability but no significant difference in speech scores. Scalable and affordable ways to address school-age hearing impairment are urgently needed in settings with a low resource for hearing health. This could potentially be implemented safely outside typical health system structures using the methods described. Registered Pan African Clinical Trial Registry(PACTR202408822942051)(2024)