Hearing Loss and Brain Health Study

NCT07288463 | Not Yet Recruiting FDA Device

• 1 other identifier: APP-25-05793
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss, Adult-Onset; Dementia

Outcome Measures

Primary Outcomes (10)

• Feasibility- Proportion of enrolled participants who complete all study periods

  Feasibility- Proportion of enrolled participants who complete all study periods

  Baseline, 3 months, and 6 months follow-up

• Feasibility - Enrollment rate (% eligible who consent)

  Feasibility - Enrollment rate (% eligible who consent)

  Baseline

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

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

  Baseline, 3 months, and 6 months follow-up

• Feasibility - Frequency of device troubleshooting encounters

  Feasibility - Frequency of device troubleshooting encounters

  Baseline, 3 months, and 6 months follow-up

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

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

  Baseline, 3 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)

  Baseline, 3 months, and 6 months follow-up

• Feasibility - Protocol adherence rate (% completing scheduled assessments)

  Feasibility - Protocol adherence rate (% completing scheduled assessments)

  Baseline, 3 months, and 6 months follow-up

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

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

  Baseline, 3 months, and 6 months follow-up

• Acceptability - International Outcome Inventory for Hearing Aids

  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.

  Baseline, 3 months, and 6 months follow-up

• Acceptability - Intention to continue use after study completion

  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).

  Baseline, 3 months, and 6 months follow-up

Secondary Outcomes (2)

• Hearing Handicap Inventory - Screening Version

  Baseline, 3 months, and 6 months follow-up

• Vanderbilt fatigue scale

  Baseline, 3 months, and 6 months follow-up

Study Arms (2)

Immediate Intervention

EXPERIMENTAL

Immediate Intervention: 3-month of OTC hearing aid use

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

Waitlist control

ACTIVE COMPARATOR

Waitlist control: Basic patient education on hearing loss without OTC hearing aid for 3 months, followed by OTC hearing aid fitting

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

Interventions

Over-The-Counter (OTC) hearing aid DEVICE

Over-The-Counter (OTC) hearing aid

Immediate Intervention; Waitlist control

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

University of Southern California

Los Angeles, California, 90066, United States

Location

MeSH Terms

Conditions

Hearing Loss; Dementia

Interventions

Hearing Aids

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Wearable Electronic Devices; Electrical Equipment and Supplies; Equipment and Supplies; Sensory Aids

Central Study Contacts

Janet Choi, MD

CONTACT

323-790-6788; choilab@usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 17, 2025
• Study Start (Estimated): July 1, 2027
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): June 30, 2031
• Last Updated: May 8, 2026

Record last verified: 2026-05

Locations

US (1)