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.

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Publication Details

Journal
Nature Communications
Published
2026-10-19
DOI
https://doi.org/10.1038/s41467-026-78833-x
Primary Topic
Hearing Loss and Rehabilitation
Type
article
Field-Weighted Citation Impact
0.00
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article

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

Charles Opondo, Dona M. P. Jayakody, Andrew Sentoogo Ssemata, Shangqiguo Wang et al.
Nature Communications
Hearing Loss and Rehabilitation
article

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

Charles Opondo, Dona M. P. Jayakody, Andrew Sentoogo Ssemata, Shangqiguo Wang, Alimu Dayimu, Qiu‐Yue Dong, Bamini Gopinath, Shidong Shang, Quinette Abegail Louw, Hongzheng Zhang, Shanquan Chen, Haibo Wang, Yao Yao, Lei Xu, Juan Feng, Fan Jiang, Yuanxi Jia, Xinxing Fu
article en

Abstract

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.

Nature Communications
Xinjiang Medical University (CN), National University of Singapore (SG), The University of Western Australia (AU), Peking University (CN), Tencent (China) (CN), University of Cambridge (GB), Stellenbosch University (ZA), First Affiliated Hospital of Xinjiang Medical University (CN), London School of Hygiene & Tropical Medicine (GB), Second Hospital of Shandong University (CN), Zhujiang Hospital (CN), Qilu Hospital of Shandong University (CN), Ear Science Institute Australia (AU), Cambridge Clinical Trials Unit (GB), MRC/UVRI & LSHTM Uganda Research Unit (UG), Southern Medical University (CN), University of Hong Kong (HK), Uganda Virus Research Institute (UG), Macquarie University (AU)
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Hearing Loss and Rehabilitation
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