Hearing Intervention for Older Adults With Mild Cognitive Impairment
Ying Chen, Haibo Shi, Mingliang Xiang, Xia Li, Zhili Wang, Wen Lu, Yilin Shen, Yuan Fang, Jie Chen, Lei Guan, Feifan Zhao, Zaichao Wu, Rong Tian, Qiongfei Yu, Kun Han, Haibin Sheng, Shengqi Chen, Jiayu Sun, Guangyu Liu, Hao Wu, , Xueling Wang, Yunge Gao, Huipeng Li, Zhentao Wang, Quan Zhou, Yiwen Zhang, Jie Liu, Yun Lin, Qiyue Shen, Anxian Wang, Jiali Yu, Sijia Xu, Jin Li, Jin Zhou, Yunqian Ma, Xue Wang, Hao Guo, Jing Feng, Ying Sun, Mengping Wang, Weiyi Peng, Yimin Zhao, Yiyuan Fu, Ye Pan, Yuqi Jiang, Yini Li, Zhengyu Shi, Yanmei Feng, Dongzhen Yu, Jingwei Lai, Qian Wan, Yuanyuan Xu, Ruotong Wang, Jiawei Feng, Mingchen Deng, Huaiwen Cao, Ran Cao, Bin Ye, Yiming Zhong, Andi Zhang, Tianyuan Zou, Dongye Guo, Jinju Xu, Qi Qiu, Jing Nie, Shaowei Zhang, Ning Su, Shixing Qian, Weihua Hu, Lian Jin, Shijun Wang, Hua Zhao, Haiya Wang, Yun Li, Wentao ShiImportance
Hearing loss is a significant modifiable risk factor for cognitive decline, but the effectiveness of hearing intervention for cognition stabilization or improvement still remains controversial.
Objective
To investigate whether hearing intervention could reduce dementia-level impairment incidence in older adults with coexisting hearing loss and mild cognitive impairment (MCI).
Design, Setting, and Participants
This multicenter, parallel-group, open-label randomized clinical trial was conducted between September 2021 and February 2024, with the 24-month follow-up completed in February 2026. This study was conducted at 3 tertiary otology outpatient clinics and 3 CHOICE cohort community health stations in Shanghai, China. Of 21 908 adults aged 60 years or older assessed for eligibility, 703 participants with coexisting MCI (Clinical Dementia Rating [CDR] global score of 0.5) and moderate to severe hearing loss were enrolled and randomized. These data were analyzed from February 2026 to July 2026.
Interventions
Participants were randomized 1:1 to receive either hearing aid intervention (n = 353) or hearing care education (n = 350).
Main Outcomes and Measures
The primary outcome was the conversion rate from MCI to dementia-level impairment over 24 months, defined as a CDR global score 1 or more. Key prespecified secondary outcomes comprised rate of cognitive improvement (CDR = 0) and CDR global and domain scores.
Results
Among 703 randomized patients (mean [SD] age, 74.53 [7.16] years; range, 60-96 years; 250 female [35.56%] and 452 male [64.44%]), 610 (86.77%) completed the trial. No significant difference was observed in the primary outcome, in which the conversion rate from MCI to dementia-level impairment was 3.09% (95% CI, 1.62%-5.74%) in the intervention group vs 4.74% (95% CI, 2.60%-8.29%) in the control group (risk difference [RD], −2.07%; 95% CI, −4.74% to 0.61%; relative risk [RR], 0.59; 95% CI, 0.25-1.38; P = .23). Meanwhile, prespecified secondary analysis demonstrated that hearing intervention increased the rate of cognitive improvement (15.34%; 95% CI, 11.84%-19.62% vs 2.36%; 95% CI, 0.99%-5.22%; RD, 12.00%; 95% CI, 8.79%-15.21%; RR, 5.94; 95% CI, 2.46-14.37). No study-related adverse events were reported.
Conclusions and Relevance
In this study, among older adults with mild cognitive impairment and coexisting hearing loss, a hearing aid intervention did not significantly reduce the incidence of dementia-level impairment at 24 months.
Trial Registration
Chinese Clinical Trial Registry Identifier: