A randomized trial of supported versus self-fitting over-the-counter hearing aids in older adults

Over-the-counter hearing aids may improve access to hearing care, but the level of support older adults need remains uncertain. In this multicenter, three-arm, pragmatic randomized controlled trial at ten community health centers in three Chinese cities, 322 adults aged 50 years or older with untreated bilateral hearing loss were randomly assigned (1:1:1) to self-fitting (n = 108), primary care physician support (n = 107), or remote audiologist support (n = 107). Outcome assessors and statisticians were masked. The primary outcome was hearing aid benefit on the Abbreviated Profile of Hearing Aid Benefit at 3 months. Here we show that both supported models produce greater benefit than self-fitting, with adjusted mean differences of 12.20 (95% confidence interval 7.18 to 17.22) for remote support and 9.71 (4.74 to 14.67) for primary care physician support. Hearing-related quality of life, satisfaction, speech recognition and device use also favor supported care, and differences persist at 12 months. One participant in the self-fitting group died of stroke. No intervention-related serious adverse events occurred. At 12 months, incremental costs per quality-adjusted life-year gained are $167.16 for physician support and $361.17 for remote support. Structured support improves the effectiveness of over-the-counter hearing aids in older adults. Chinese Clinical Trial Registry: ChiCTR2400086117. In a multicenter pragmatic trial, structured primary care physician or remote audiologist support improved the benefits and sustained use of over-the-counter hearing aids in older adults compared with self-fitting.