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Over-the-counter hearing aids for older adults with hearing loss and dementia risk

Tests whether older adults with mild-to-moderate hearing loss can use store-bought hearing aids.

Key facts

Who runs it
University of Southern California
Where
Los Angeles, United StatesSee the site
Trial code
Registry title
Hearing Loss and Brain Health Study
Status
Not yet recruiting
People taking part
40 people, planned
Starts
1 Jul 2027
Expected to end
30 Jun 2031
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Over-The-Counter (OTC) hearing aid
Record updated
8 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 50 or older with mild to moderate hearing loss in both ears who do not have dementia. It tests over-the-counter hearing aids.

Age
50 years and older
Sex
All sexes
Disease stage
Mild to moderate sensorineural hearing loss (inner ear or nerve type) in both ears. No dementia diagnosis.
Earlier treatment
People must not be using hearing aids or cochlear implants now.
Biomarker or test result
APOE status (a gene test result) must be known.

Main reasons for not taking part

  • Clinical diagnosis of dementia
  • Severe or profound hearing loss, or hearing loss since birth (self-reported)
  • No ear canal, or a medical reason not to use hearing aids, such as a draining ear
  • Known retrocochlear pathology (a problem in the hearing nerve or brain pathway)
  • Not willing to wear the hearing aids at least 4 hours/day, or severe uncorrected vision or hand problems that prevent handling the device

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Absence of an ear canal due to medical conditions or prior surgical procedures
  • Clinical diagnosis of dementia
  • Severe uncorrected visual impairment or significant manual dexterity limitations that prevent handling the device
  • Severe or profound hearing loss
  • Self-reported congenital hearing loss
  • unwillingness to wear OTC hearing aids regularly (>=4 hours/day)
  • medical contraindication to use hearing aids (e.g., actively draining ear)
  • Known retrocochlear pathology

Where in United States

  • University of Southern CaliforniaLos Angeles, United StatesContact: Janet Choi, MDNot yet recruiting

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Immediate InterventionTreatment being tested

    Immediate Intervention: 3-month of OTC hearing aid use

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

  • Waitlist controlExisting treatment, for comparison

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

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Hearing Loss and Brain Health Study
Plain-language title
Over-the-counter hearing aids for older adults with hearing loss and dementia riskGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
8 May 2026