NCT06112860 · RECRUITING
OTC Hearing Aid and MCI
This trial is testing whether over-the-counter hearing aids improve communication in people who already have mild cognitive impairment or early dementia and also have mild to moderate hearing loss. It also compares hearing aids against communication strategy coaching. This is a Phase N/A pragmatic trial, meaning it is evaluating real-world usefulness rather than safety from scratch. Participants and a communication partner are both involved.
You may qualify if
- Over 60 years of age
- Mild dementia or mild cognitive impairment. Diagnosis will be made at participating memory evaluation centers (see recruitment).
- Mild to moderate bilateral hearing loss and no current hearing aid use.
- A communication partner who is able and willing to participate in the study.
- No vision impairment that would interfere with the ability to complete study tasks (i.e., legally blind, severe cataracts, or macular degeneration)
- Able to provide own consent as evaluated by the Consent Assessment
You're excluded if
- Clinically significant unstable or progressive medical conditions, or conditions which, in the opinion of the investigator(s) places the participant at unacceptable risk if he or she were to participate in the study.
- History of unresolved communication difficulties following another neurological problem (i.e., stroke or brain tumor), neurodevelopmental disorder (i.e., Down's syndrome), or head/neck cancer
- Positive history of major psychiatric disorder (i.e., schizophrenia, significant untreated depression)
- Co-enrolled in other intervention studies targeting hearing, language, or communication strategies.
- History or current fluctuating hearing loss
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-09-19