Hearing Loss and Genetic Risks for Alzheimer's Disease and Related Dementia

University of Southern California

Status: Begins enrollment in a year or more

Conditions: Hearing Loss, Adult-Onset; Dementia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07288463

APP-25-05793

Details and patient eligibility

About

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 at increased risk for dementia. 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: 4-mo using OTC hearing aids or (2) waitlist control: 2-mo without devices followed by an additional 4-mo using OTC hearing aids. 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 listenign efforts. Findings will inform the design of larger trials aimed at improving access to hearing care and promoting cognitive health in high-risk older adults.

Enrollment: 20 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age >= 50 years
• APOE ε4 carriers
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

20 participants in 2 patient groups

Immediate Intervention

Experimental group

Description:

Immediate Intervention: 4-month of OTC hearing aid use

Treatment:

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

Waitlist control

Active Comparator group

Description:

Waitlist control: Basic patient education on hearing loss without OTC hearing aid for 2 months, followed by 4 months of OTC hearing aid use

Treatment:

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