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In the CHOICE trial, hearing aids did not produce a statistically significant reduction in progression from mild cognitive impairment to dementia over 24 months. A secondary outcome found a higher rate of improvement in the hearing aid group, but researchers and editorialists say the finding needs replication.
The CHOICE trial found no statistically significant reduction in progression to dementia among older adults with mild cognitive impairment and hearing loss assigned to hearing aids, but a secondary measure showed more participants in that group improved cognitively over 24 months. The improvement result is a signal that requires confirmation, while the trial’s primary result does not establish that hearing aids prevent dementia.
Among the 703 participants, 353 were assigned a hearing aid intervention and 350 received hearing care education. The trial’s primary outcome was conversion from mild cognitive impairment to dementia-level impairment, measured using the Clinical Dementia Rating (CDR). Conversion occurred in 3.09% of the intervention group and 4.74% of the control group. Researchers reported a relative risk of 0.59 and a P value of 0.23, so the difference was not statistically significant.
A prespecified secondary outcome tracked improvement from a CDR global score of 0.5, used to define mild cognitive impairment in the study, to 0. The rate was 15.34% among participants assigned hearing aids, compared with 2.36% in the control group. The researchers reported a relative risk of 5.94 and P<0.001. This result indicates an association within the trial; it does not show that hearing aids will lead to cognitive improvement for every person with hearing loss or mild cognitive impairment.
The study was conducted from 2021 to 2026 at three tertiary otology outpatient clinics and three community health stations in Shanghai. Participants had moderate-to-severe hearing loss and mild cognitive impairment, with a mean age of 74.5; 64% were men. The research team, led by Hao Wu of Shanghai Jiao Tong University School of Medicine, reported the results in JAMA Neurology, according to MedPage Today.
A Possible Route to Cognitive Improvement
The results matter because hearing loss is considered a modifiable risk factor for dementia, and the trial tested hearing care in a group already experiencing mild cognitive impairment. The secondary finding raises the possibility that hearing treatment could be associated with improvement on a measure of everyday cognitive and functional capacity, rather than only a slower decline. That possibility is not established by this study, and the primary outcome did not demonstrate a statistically significant reduction in dementia conversion.
Hearing aids have benefits that do not depend on a dementia finding. Wu told MedPage Today that they have established benefits for communication, social engagement and quality of life. For readers weighing hearing care, CHOICE adds a research signal for people with mild cognitive impairment, but it does not settle whether hearing aids change the course of cognitive impairment. The result needs to be tested in further studies before it can support a firm conclusion about cognitive benefit.
How CHOICE Fits Earlier Research
The 2023 ACHIEVE trial was described as the first study to evaluate a hearing intervention for preventing cognitive decline. It found no overall treatment effect after three years among older adults who were cognitively intact at the start. An analysis of a high-risk subgroup in ACHIEVE found a significant 48% relative reduction in cognitive change among those receiving the hearing intervention, according to an editorial by Justin Golub of Columbia University Irving Medical Center and co-authors.
The editorialists said the high-risk subgroup in ACHIEVE provides relevant context for CHOICE, where all participants had mild cognitive impairment at enrollment. They also cautioned that CHOICE’s large secondary-outcome effect needs replication, particularly because its primary outcome was null. These studies involved different participant groups and outcomes, so their findings do not establish the same effect across all older adults.
“The null primary result should be read as ‘not proven,’ rather than ‘no benefit.'”
— Hao Wu, MD, PhD, lead researcher, speaking to MedPage Today
Limits of the Improvement Finding
The primary outcome result does not establish that the intervention reduced dementia incidence. The researchers said the conversion rate was lower than expected, making the trial underpowered to assess that outcome. A nonsignificant result means the trial did not prove a reduction; it does not by itself determine whether a benefit exists.
The cognitive improvement result was a secondary outcome, and its size surprised the editorialists. Wu and co-authors also noted limitations: the CDR score of 0.5 eligibility criterion was not prespecified in the protocol or trial registration, potentially introducing selection bias. Using the subjective CDR scale for both screening and outcomes may also have introduced evaluation bias. The available report does not establish whether the same improvement rate would appear in other settings or patient populations.
Replication Will Test the Signal
The next step is replication in further studies to determine whether the higher rate of improvement holds in comparable older adults with hearing loss and mild cognitive impairment. Researchers will also need evidence from adequately powered studies to clarify whether hearing intervention affects progression to dementia, the primary outcome that CHOICE did not resolve.
For now, the trial supports a careful reading: participants assigned hearing aids improved more often on the study’s CDR measure, while the study did not demonstrate a statistically significant reduction in dementia conversion. Whether the improvement finding can be reproduced, and how it relates to longer-term outcomes, remains open.
Key Questions
Did the CHOICE trial show that hearing aids prevent dementia?
No. The primary outcome did not show a statistically significant reduction in conversion to dementia over 24 months. The trial’s result does not prove that hearing aids prevent dementia.
What cognitive improvement did researchers report?
Improvement from a CDR global score of 0.5 to 0 occurred in 15.34% of the hearing aid group and 2.36% of the control group. Researchers reported this as a secondary outcome that needs confirmation.
Who took part in the trial?
The study enrolled 703 older adults in Shanghai with moderate-to-severe hearing loss and mild cognitive impairment. Their mean age was 74.5 years, and 64% were men.
Why do researchers say the results need more study?
The dementia conversion rate was lower than researchers had expected, leaving the primary outcome underpowered. The improvement result was a secondary finding, and the researchers cited potential selection and evaluation bias related to the study’s CDR criteria and measurements.
Source: rss
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