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 at increased risk for dementia. 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: 4-mo using OTC hearing aids or (2) waitlist control: 2-mo without devices followed by an additional 4-mo using OTC hearing aids. 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 listenign efforts. Findings will inform the design of larger trials aimed at improving access to hearing care and promoting cognitive health in high-risk older adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
20
Over-The-Counter (OTC) hearing aid
University of Southern California
Los Angeles, California, United States
Feasibility- Proportion of enrolled participants who complete all study periods
Feasibility- Proportion of enrolled participants who complete all study periods
Time frame: Baseline, 2-months, 4-months, and 6-months follow up
Feasibility - Enrollment rate (% eligible who consent)
Feasibility - Enrollment rate (% eligible who consent)
Time frame: Baseline
Feasibility - Study visit completion rate (% of planned visits completed)
Feasibility - Study visit completion rate (% of planned visits completed)
Time frame: Baseline, 2-months, 4-months, and 6-months follow up
Feasibility - Frequency of device troubleshooting encounters
Feasibility - Frequency of device troubleshooting encounters
Time frame: Baseline, 2-months, 4-months, and 6-months follow up
Feasibility - Percentage achieving >= 4hours/day of objective wear time
Feasibility - Percentage achieving \>= 4hours/day of objective wear time
Time frame: Baseline, 2-months, 4-months, and 6-months follow up
Feasibility - Hearing aid use adherence (mean daily wear time from data-logging)
Feasibility - Hearing aid use adherence (mean daily wear time from data-logging)
Time frame: Baseline, 2-months, 4-months, and 6-months follow up
Feasibility - Protocol adherence rate (% completing scheduled assessments)
Feasibility - Protocol adherence rate (% completing scheduled assessments)
Time frame: Baseline, 2-months, 4-months, and 6-months follow up
Feasibility - Retention rate (% completing follow-up visits)
Feasibility - Retention rate (% completing follow-up visits)
Time frame: Baseline, 2-months, 4-months, and 6-months follow up
Acceptability - International Outcome Inventory for Hearing Aids
International Outcome Inventory for Hearing Aids
Time frame: Baseline, 2-months, 4-months, and 6-months follow up
Acceptability - Intention to continue use after study completion
Acceptability - Intention to continue use after study completion
Time frame: Baseline, 2-months, 4-months, and 6-months follow up
Hearing Handicap Inventory - Screening Version
Hearing Handicap Inventory - Screening Version
Time frame: Baseline, at the end of period 1 (4-week from baseline), at the end of period 2 (8-week from baseline)
Vanderbilt fatigue scale
Listeing-related fatigue: Vanderbilt fatigue scale
Time frame: Baseline, 2-months, 4-months, and 6-months follow up
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