Hearing Loss and Brain Health Study

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorUniversity of Southern California

About this trial

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.

Eligibility criteria

Qualifiers

Age >= 50 years

Known APOE status

Bilateral mild to moderate sensorineural hearing loss

No current use of hearing aids or cochlear implants

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Over-The-Counter (OTC) hearing aid

Treatment groups

40 Participants
are divided into 2 treatment groups