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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dementia; Hearing Loss, Adult-Onset
• Intervention / Treatment: Device: Over-The-Counter (OTC) hearing aid

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Janet Choi, MD; Phone Number: 323-790-6788; Email: choilab@usc.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90066
      • University of Southern California
      • Contact: Janet Choi, MD; Phone Number: 323-790-6788; Email: choilab@usc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate Intervention; Immediate Intervention: 3-month of OTC hearing aid use	Device: Over-The-Counter (OTC) hearing aid; Over-The-Counter (OTC) hearing aid
Active Comparator: Waitlist control; 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; Over-The-Counter (OTC) hearing aid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility - Enrollment rate (% eligible who consent)	Feasibility - Enrollment rate (% eligible who consent)	Baseline
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 - 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 3 months, and 6 months follow-up
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.	Baseline, 3 months, and 6 months follow-up

Collaborators and Investigators

• Sponsor: University of Southern California

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2027
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): June 30, 2031

Study Registration Dates

• First Submitted: December 15, 2025
• First Submitted That Met QC Criteria: December 15, 2025
• First Posted (Actual): December 17, 2025

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Dementia; Hearing Loss; Equipment and Supplies; Electrical Equipment and Supplies; Wearable Electronic Devices; Sensory Aids; Hearing Aids
• Other Study ID Numbers: APP-25-05793

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: At this time, individual participant data (IPD) will not be shared. Because this is a small feasibility pilot study involving a high-risk population, and the primary study outcomes are feasibility and acceptability metrics rather than clinical endpoints, we do not anticipate that sharing individual-level data would provide meaningful scientific value.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes