NCT04618315

P-CHAT: Comparison of Direct to Consumer Delivery Models for Hearing Devices

Patient-Centered Hearing Aid Trial: Comparison of Direct to Consumer Delivery Models for Hearing Devices

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 584 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 50 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

Satisfaction and benefit from hearing aids fit using two patient self fit methods will be compared against those fit using audiology-based best practices. Individuals between the ages of 50 and 79 years of age will be randomly assigned to one of three fitting methods. Benefit and satisfaction will be evaluated six weeks and six months after the initial fitting.

Detailed description

Hearing aids are the most pertinent treatment for most adults with hearing loss, a pervasive chronic health problem in \~40% of those over the age of 60 years. Only 20% of these individuals purchase and use hearing aids. The Over-the-Counter Hearing Aid Act of 2017 is designed to increase affordability and accessibility, and thereby adoption, of hearing aids. While this legislation directs the Food and Drug Administration (FDA) to create and administer this new channel of hearing aid provision by 2020, best practices related to hearing aid provision without the involvement of a professional, licensed provider have not been explored and established. Patients do not have the evidence they need to decide between modes of acquiring hearing aids. The current proposal addresses the specific knowledge gap of efficacious direct-to-consumer hearing aid delivery models. Two methods of patient-driven methods of selecting and fitting hearing aids will be compared against audiology-based best practice fitting. Individuals who perceive mild or moderate hearing difficulty will be randomly assigned to one of three fitting arms. Satisfaction and benefit from hearing aids will be assessed at six weeks and six months after initial fit.

Conditions

• Hearing Aids
• Hearing Loss

Interventions

Type	Name	Description
DEVICE	Hearing Aids	Receiver-in-the-ear hearing aids.

Timeline

• Start date: 2020-12-01
• Primary completion: 2024-04-01
• Completion: 2024-06-30
• First posted: 2020-11-05
• Last updated: 2025-03-06
• Results posted: 2025-03-06

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study