Hearing Loss and Brain Health Study

Starting soon · Not applicable

Conditions studied: Hearing Loss, Adult-Onset, Dementia

In brief

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.

Key facts

Study ID

NCT07288463

Run by

University of Southern California

People needed

40

Starts

2027-07-01

Expected to finish

2031-06-30

Last updated by the study team

2026-05-08

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• University of Southern California — Los Angeles, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.