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Over-the-counter hearing aids reduce depression symptoms in older adults with hearing loss: a randomized controlled trial

Nature Mental Health volume 3, pages 498–506 (2025)Cite this article

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Abstract

Previous studies have shown that hearing loss doubles the risk of depression in older adults, and this parallel, randomized, controlled, open-label trial aims to assess the effectiveness of community health worker-delivered over-the-counter (OTC) hearing aids on depression symptoms in this population. The primary outcome is the change in depression symptoms at 6 months from baseline. Secondary outcomes include communication function, loneliness and social isolation. Older adults aged 60 years or older with mild to moderately severe hearing loss were randomized 1/1 to the OTC hearing aid intervention (n = 109) or a wait-list control group (n = 112) between 1 April and 5 July 2023. Depression symptoms, as measured by the short Geriatric Depression Scale (GDS-15), improved in the intervention group at 6 months (mean difference –1.65; 95% confidence interval 1.18, 1.58; P < 0.001). Similar improvements were seen in communication function, social isolation and loneliness. Approximately 80% of participants maintained >4 hours of hearing aid use per day. No adverse events were reported in this trial. The study demonstrated that community health worker-delivered OTC hearing aids are effective in reducing depression symptoms in older adults with hearing loss. Trial registration: ChiCTR2300069838.

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Fig. 1: Study flow chart.
Fig. 2: Subgroup analysis of depression symptoms.
Fig. 3: Wearing times of OTC hearing aids at 3 months and 6 months.

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Data availability

De-identified participant data that support the findings of this study are openly available via Figshare at https://doi.org/10.6084/m9.figshare.27115603.

Code availability

No custom computational code or software was developed for this study. Analyses were performed with publicly available software packages as described in Methods. The analysis code for this study is available on request from the corresponding author.

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Acknowledgments

We thank participants and community health workers in Wujiabao, Meilihu, Xingfu, Taoyuan, Zhenxing, Lashan, Dahuaishu, Yanqianhu, Daode and Yingshi health-care centers who participated in this trial. We acknowledge funding by grant of the National Natural Science Foundation of China (NNSFC) (82471176, 82071053) to L.X. and NNSFC (72204143) to F.J.; the Major Fundamental Research Program of the Natural Science Foundation of Shandong Province, China (R2021ZD40) to H.W.; Taishan Scholars Program of Shandong Province-Youth Scholar Program (tsqn202211357) to L.X.; Natural Science Foundation of Shandong Province of China (ZR2022QG081) to F.J. The funders had no role in study design, data collection and analysis, decision to publish or preparation of the manuscript.

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Authors and Affiliations

  1. Shandong Provincial ENT Hospital, School of Public Health, Shandong University, Jinan, China

    Fan Jiang, Qiuyue Dong, Xiaofei Li, Haibo Wang & Lei Xu

  2. Centre for Health Management and Policy Research, School of Public Health, Cheeloo College of Medicine, Shandong University, Jinan, China

    Fan Jiang, Peipei Fu & Chengchao Zhou

  3. Cambridge Clinical Trials Unit Cancer Theme, University of Cambridge, Cambridge, UK

    Alimu Dayimu

  4. Shandong Institute of Otorhinolaryngology, Jinan, China

    Qiuyue Dong, Xiaofei Li, Haibo Wang & Lei Xu

  5. School of Management, Shandong Second Medical University, Weifang, China

    Qi Jing

  6. Institute of Population Ageing, University of Oxford, Oxford, UK

    Qi Jing

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Contributions

L.X., H.W., C.Z. and F.J. conceived the study and contributed to interpretation of the results. A.D., Q.D. and F.J. analyzed data and drafted the first paper. L.X., Q.J., X.L., P.F. and H.W. contributed to critical revision of the paper. The corresponding authors attest that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted. All authors confirm that they had access to the data and accept responsibility for the decision to submit for publication.

Corresponding authors

Correspondence to Chengchao Zhou, Haibo Wang or Lei Xu.

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Jiang, F., Dayimu, A., Dong, Q. et al. Over-the-counter hearing aids reduce depression symptoms in older adults with hearing loss: a randomized controlled trial. Nat. Mental Health 3, 498–506 (2025). https://doi.org/10.1038/s44220-025-00408-4

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