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Hearing Loss and Brain Health Study

This study is looking at whether over-the-counter (OTC) hearing aids can help older adults with mild to moderate hearing loss, especially those who might be at higher risk for memory problems (dementia). We want to see if these hearing aids are easy to use and if people are willing to use them. You might be able to join if you are 50 or older, have mild to moderate hearing loss in both ears, and do not currently use hearing aids. You also need to know your APOE status (a genetic marker). This study plans to enroll 40 participants and is currently unclear about its recruitment status.

Study design
This is an interventional study with a planned enrollment of 40 participants. It is a pilot study focused on feasibility and acceptability.
What's involved
Participants will undergo standardized hearing screening and complete questionnaires. Follow-up visits are planned at Baseline, 3 months, and 6 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 months after starting the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07288463

Hearing Loss and Brain Health Study

Not Yet Recruiting
NAAges 50+InterventionalTreatment
University of Southern California
~40 participants
Updated 2026-05-08 on ClinicalTrials.gov
What's tested:Over-The-Counter (OTC) hearing aid

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility- Proportion of enrolled participants who complete all study periods
Measured over Baseline, 3 months, and 6 months follow-up
+9 more outcomes measured

Conditions

Hearing Loss, Adult-Onset
Dementia

Explore related trials

DementiaHearing LossAPOE Gene

Where it's being run

1 sites across 1 states
California1

Who to contact

Janet Choi, MD
[email protected]
323-790-6788
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Feasibility- Proportion of enrolled participants who complete all study periodsBaseline, 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 encountersBaseline, 3 months, and 6 months follow-up

    Feasibility - Frequency of device troubleshooting encounters

  • Feasibility - Percentage achieving >= 6hours/day of objective wear timeBaseline, 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)

  • 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 AidsBaseline, 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.

  • Acceptability - Intention to continue use after study completionBaseline, 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).