About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age >= 50 years

Known APOE status

Bilateral mild to moderate sensorineural hearing loss

No current use of hearing aids or cochlear implants

Disqualifiers

Clinical diagnosis of dementia

Severe or profound hearing loss

Self-reported congenital hearing loss

Absence of an ear canal due to medical conditions or prior surgical procedures

Trial design

Design model

Parallel

Treatments tested in this trial

Over-The-Counter (OTC) hearing aid
Device
Over-The-Counter (OTC) hearing aid

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: Immediate InterventionExperimental treatment 1 intervention

Group B: Waitlist controlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility- Proportion of enrolled participants who complete all study periods

Time frame

Baseline, 3 months, and 6 months follow-up

2

Feasibility - Enrollment rate (% eligible who consent)

Time frame

Baseline

3

Feasibility - Study visit completion rate (% of planned visits completed)

Time frame

Baseline, 3 months, and 6 months follow-up

4

Feasibility - Frequency of device troubleshooting encounters

Time frame

Baseline, 3 months, and 6 months follow-up

Secondary outcomes

1

Hearing Handicap Inventory - Screening Version

Hearing Handicap Inventory for the Elderly - Screening Version (HHIE-S) The HHIE-S is a 10-item self-report questionnaire assessing the emotional and social/situational effects of hearing loss in older adults. Total scores range from 0 to 40, with higher scores indicating greater perceived hearing handicap and worse hearing-related quality of life. Minimum score: 0; maximum score: 40. Higher scores represent worse outcomes.

Time frame

Baseline, 3 months, and 6 months follow-up

2

Vanderbilt fatigue scale

Vanderbilt Fatigue Scale - Adult Hearing Loss (VFS-AHL) The Vanderbilt Fatigue Scale - Adult Hearing Loss (VFS-AHL) is a self-report measure assessing listening-related fatigue in adults with hearing loss. Scores are derived using item-response theory-based scoring and are typically transformed to a standardized scale ranging from approximately -2 to +2 logits, with higher scores indicating greater fatigue and worse outcomes. Higher scores represent worse listening-related fatigue.

Time frame

Baseline, 3 months, and 6 months follow-up

Hearing Loss and Brain Health Study

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts