Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07288463

Hearing Loss and Brain Health Study

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Hearing Loss, Adult-Onset Brain Diseases Central Nervous System Diseases Dementia Ear Diseases Hearing Disorders Hearing Loss Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Southern California

Los Angeles, California, 90066, United States

Location contact

Janet Choi, MD

CONTACT

[email protected]

323-790-6788

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Over-The-Counter (OTC) hearing aid

Device

Over-The-Counter (OTC) hearing aid

Primary outcomes

  1. Feasibility- Proportion of enrolled participants who complete all study periods

    Time frame: Baseline, 3 months, and 6 months follow-up

    Feasibility- Proportion of enrolled participants who complete all study periods

  2. Feasibility - Enrollment rate (% eligible who consent)

    Time frame: Baseline

    Feasibility - Enrollment rate (% eligible who consent)

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

    Time frame: Baseline, 3 months, and 6 months follow-up

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

  4. Feasibility - Frequency of device troubleshooting encounters

    Time frame: Baseline, 3 months, and 6 months follow-up

    Feasibility - Frequency of device troubleshooting encounters

  5. Feasibility - Percentage achieving >= 6hours/day of objective wear time

    Time frame: Baseline, 3 months, and 6 months follow-up

    Feasibility - Percentage achieving >= 4hours/day of objective wear time

  6. Feasibility - Hearing aid use adherence (mean daily wear time from data-logging)

    Time frame: Baseline, 3 months, and 6 months follow-up

    Feasibility - Hearing aid use adherence (mean daily wear time from data-logging)

  7. Feasibility - Protocol adherence rate (% completing scheduled assessments)

    Time frame: Baseline, 3 months, and 6 months follow-up

    Feasibility - Protocol adherence rate (% completing scheduled assessments)

  8. Feasibility - Retention rate (% completing follow-up visits)

    Time frame: Baseline, 3 months, and 6 months follow-up

    Feasibility - Retention rate (% completing follow-up visits)

  9. Acceptability - International Outcome Inventory for Hearing Aids

    Time frame: 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.

  10. Acceptability - Intention to continue use after study completion

    Time frame: 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).

Secondary outcomes

  1. Hearing Handicap Inventory - Screening Version

    Time frame: 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.

  2. Vanderbilt fatigue scale

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Janet Choi, MD

CONTACT

[email protected]

323-790-6788

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Important dates

Study start
2027
Primary completion
2030
Study completion
2031
First posted
Dec 17, 2025
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.