Hearing loss is a prevalent and modifiable risk factor for cognitive decline and dementia in older adults, yet access to hearing care remains limited. Over-the-counter (OTC) hearing aids represent a promising and scalable strategy to expand access, particularly for individuals at elevated risk for dementia who may benefit most from earlier intervention. This pilot study aims to evaluate the feasibility and acceptability of OTC hearing aid use among older adults. Participants aged ≥50 years will undergo standardized hearing screening to identify bilateral, mild-to-moderate hearing loss. Eligible participants will be randomized to one of two sequences: (1) immediate intervention: 3-mo using OTC hearing aids or (2) waitlist control: 3-mo without devices followed by OTC hearing aid use after 3 months. Feasibility outcomes include study enrollment and retention, protocol adherence, and average daily device use determined by data-logging. Acceptability outcomes will be assessed using the International Outcome Inventory for Hearing Aids (IOI-HA), device satisfaction ratings, and participant intention to continue hearing-aid use. Hearing outcomes include validated questionnaires on hearing and listening efforts. Findings will inform the design of larger trials aimed at improving access to hearing care and promoting cognitive health.
Age range
50 Years
Sex
ALL
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The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Feasibility- Proportion of enrolled participants who complete all study periods
Timeframe: Baseline, 3 months, and 6 months follow-up
Feasibility - Enrollment rate (% eligible who consent)
Timeframe: Baseline
Feasibility - Study visit completion rate (% of planned visits completed)
Timeframe: Baseline, 3 months, and 6 months follow-up
Feasibility - Frequency of device troubleshooting encounters
Timeframe: Baseline, 3 months, and 6 months follow-up
Feasibility - Percentage achieving >= 6hours/day of objective wear time
Timeframe: Baseline, 3 months, and 6 months follow-up
Feasibility - Hearing aid use adherence (mean daily wear time from data-logging)
Timeframe: Baseline, 3 months, and 6 months follow-up
Feasibility - Protocol adherence rate (% completing scheduled assessments)
Timeframe: Baseline, 3 months, and 6 months follow-up
Feasibility - Retention rate (% completing follow-up visits)
Timeframe: Baseline, 3 months, and 6 months follow-up
Acceptability - International Outcome Inventory for Hearing Aids
Timeframe: Baseline, 3 months, and 6 months follow-up
Acceptability - Intention to continue use after study completion
Timeframe: Baseline, 3 months, and 6 months follow-up