Hearing Intervention for Older Adults With Mild Cognitive Impairment: The CHOICE Randomized Clinical Trial.
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.
To investigate whether hearing intervention could reduce dementia-level impairment incidence in older adults with coexisting hearing loss and mild cognitive impairment (MCI).
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.
Participants were randomized 1:1 to receive either hearing aid intervention (n = 353) or hearing care education (n = 350).
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.
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.
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.
Chinese Clinical Trial Registry Identifier: ChiCTR2000036139.
To investigate whether hearing intervention could reduce dementia-level impairment incidence in older adults with coexisting hearing loss and mild cognitive impairment (MCI).
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.
Participants were randomized 1:1 to receive either hearing aid intervention (n = 353) or hearing care education (n = 350).
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.
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.
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.
Chinese Clinical Trial Registry Identifier: ChiCTR2000036139.
Authors
Chen Chen, Shi Shi, Xiang Xiang, Li Li, Wang Wang, Lu Lu, Shen Shen, Fang Fang, Chen Chen, Guan Guan, Zhao Zhao, Wu Wu, Tian Tian, Yu Yu, Han Han, Sheng Sheng, Chen Chen, Sun Sun, Liu Liu, Wu Wu,
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