Dementia, Hearing Loss, Adult-Onset
Conditions
Brief summary
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.
Interventions
DEVICEOver-The-Counter (OTC) hearing aid
Over-The-Counter (OTC) hearing aid
Sponsors
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>= 50 years * Known APOE status * Bilateral mild to moderate sensorineural hearing loss * No current use of hearing aids or cochlear implants * No diagnosis of dementia and able to provide informed consent * Able to complete questionnaires and follow instructions in English * Willing and able to comply with study procedures, follow-up visits, and hearing-aid use
Exclusion criteria
* 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 * unwillingness to wear OTC hearing aids regularly (\>=4 hours/day) * medical contraindication to use hearing aids (e.g., actively draining ear) * Known retrocochlear pathology * Severe uncorrected visual impairment or significant manual dexterity limitations that prevent handling the device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability - Intention to continue use after study completion | Baseline, 3 months, and 6 months follow-up | Acceptability - Intention to continue use after study completion Participant-reported intention to continue hearing aid use after study completion will be assessed using a Likert-scale questionnaire. Responses are scored on a 5-point scale ranging from 1 to 5, with higher scores indicating greater willingness and acceptability for continued hearing aid use. Minimum score: 1; maximum score: 5. Higher scores represent better outcomes (greater intention to continue use). |
| Feasibility - Retention rate (% completing follow-up visits) | Baseline, 3 months, and 6 months follow-up | Feasibility - Retention rate (% completing follow-up visits) |
| Acceptability - International Outcome Inventory for Hearing Aids | Baseline, 3 months, and 6 months follow-up | International Outcome Inventory for Hearing Aids (IOI-HA) The IOI-HA is a 7-item self-report questionnaire assessing hearing aid outcomes across domains including daily use, benefit, residual activity limitation, satisfaction, residual participation restriction, impact on others, and quality of life. Each item is scored on a 5-point Likert scale, with total scores ranging from 7 to 35. Higher scores indicate better hearing aid outcomes and greater perceived benefit/satisfaction. |
| Feasibility- Proportion of enrolled participants who complete all study periods | Baseline, 3 months, and 6 months follow-up | Feasibility- Proportion of enrolled participants who complete all study periods |
| Feasibility - Enrollment rate (% eligible who consent) | Baseline | Feasibility - Enrollment rate (% eligible who consent) |
| Feasibility - Study visit completion rate (% of planned visits completed) | Baseline, 3 months, and 6 months follow-up | Feasibility - Study visit completion rate (% of planned visits completed) |
| Feasibility - Frequency of device troubleshooting encounters | Baseline, 3 months, and 6 months follow-up | Feasibility - Frequency of device troubleshooting encounters |
| Feasibility - Percentage achieving >= 6hours/day of objective wear time | Baseline, 3 months, and 6 months follow-up | Feasibility - Percentage achieving \>= 4hours/day of objective wear time |
| Feasibility - Hearing aid use adherence (mean daily wear time from data-logging) | Baseline, 3 months, and 6 months follow-up | Feasibility - Hearing aid use adherence (mean daily wear time from data-logging) |
| Feasibility - Protocol adherence rate (% completing scheduled assessments) | Baseline, 3 months, and 6 months follow-up | Feasibility - Protocol adherence rate (% completing scheduled assessments) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vanderbilt fatigue scale | Baseline, 3 months, and 6 months follow-up | 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. |
| Hearing Handicap Inventory - Screening Version | Baseline, 3 months, and 6 months follow-up | 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. |
Countries
United States
Contacts
CONTACTJanet Choi, MD
Outcome results
None listed