A hearing aid intervention did not reduce the rate of progression from mild cognitive impairment to dementia over a 24-month period in the CHOICE clinical trial, according to findings published in JAMA Neurology. However, researchers observed a secondary outcome indicating that participants using hearing aids experienced a significantly higher rate of cognitive improvement compared to a control group.
CHOICE Trial Primary Outcome Findings and Limitations
The randomized controlled trial, conducted from 2021 to 2026 across three tertiary otology outpatient clinics and three community health stations in Shanghai, evaluated 703 older adults diagnosed with moderate-to-severe hearing loss and co-existing mild cognitive impairment. Participants had a mean age of 74.5 years, and 64% were men. The cohort was divided, with 353 individuals assigned to receive a hearing aid intervention and 350 assigned to hearing care education.
The primary outcome measured the conversion rate from mild cognitive impairment—defined as a Clinical Dementia Rating (CDR) global score of 0.5—to dementia-level impairment, represented by a CDR score of 1. Over 24 months, the dementia conversion rate was 3.09% in the hearing aid intervention group and 4.74% in the control group. This yielded a risk difference of -2.07% and a relative risk of 0.59, which was not statistically significant at P=0.23, as reported by Hao Wu, MD, PhD, of the Shanghai Jiao Tong University School of Medicine in China, and his co-authors.
Wu explained that the observed 24-month conversion rate was substantially lower than researchers anticipated based on pilot data and previous literature, which estimated conversion rates of 10% for hearing aid users and 18% for non-users. Because of the lower-than-expected conversion rate, the study was underpowered for its primary endpoint. Wu stated that the null primary result should be interpreted as “not proven” rather than demonstrating “no benefit.”
Secondary Cognitive Improvement Outcomes
While the primary endpoint did not reach statistical significance, a prespecified secondary outcome tracked the rate of cognitive improvement from a CDR global score of 0.5 back to normal cognition (CDR score of 0). The rate of cognitive improvement reached 15.34% in the hearing aid intervention group, compared to 2.36% in the control group. This demonstrated a nearly sixfold greater chance of cognitive improvement for participants who received hearing aids, with a relative risk of 5.94.
Wu noted that these findings suggest treating hearing loss may help a meaningful minority of older adults with mild cognitive impairment regain everyday cognitive and functional capacity, rather than simply slowing cognitive decline. The study authors acknowledged several methodological limitations, including that the eligibility criterion limiting enrollment to individuals with a CDR score of 0.5 was not prespecified in the protocol or trial registration, potentially introducing selection bias. Reliance on the subjective CDR scale for screening and outcome evaluation introduced potential evaluation bias.
Context Within Recent Hearing and Dementia Research
Hearing loss is widely recognized as a key modifiable risk factor for dementia. In 2023, the ACHIEVE trial became the first study to evaluate a hearing intervention for the prevention of cognitive decline. That three-year study reported no overall treatment effect among cognitively intact older adults. However, a secondary subgroup analysis of high-risk participants in ACHIEVE demonstrated a significant 48% relative reduction in cognitive change among those who received a hearing intervention.
Justin Golub, MD, MS, of Columbia University Irving Medical Center in New York City, and co-authors published an editorial in JAMA Otolaryngology–Head & Neck Surgery discussing the CHOICE trial results. The editorialists noted that the ACHIEVE findings substantiate the significant secondary outcome observed in CHOICE, given that all CHOICE participants had mild cognitive impairment at randomization and belonged to a high-risk category for cognitive decline.
Golub and colleagues described the effect size in the CHOICE secondary outcome as surprisingly giant, noting it requires replication. They concluded that intervention with hearing aids may provide an important protective effect for older adults at increased risk of cognitive decline, even if that effect is absent in lower-risk populations. Wu emphasized that hearing aids deliver well-established benefits for communication, social engagement, and quality of life regardless of their direct impact on cognition.
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