Patient-Centered Hearing Aid Trial
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Hearing Aids
- Hearing Loss
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Three arm blinded randomized control trial.Masking: Double (Investigator, Outcomes Assessor)Masking Description: The principle investigators and the audiologists conducting the outcome measures will be blinded to group assignment.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 50 years and 79 years
- Gender
- Both males and females
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 affordabili...
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.
Tracking Information
- NCT #
- NCT04618315
- Collaborators
- Leslie Rolph
- Tom Wardzala
- Malini Patel
- Tracy Winn
- Larry E. Humes
- Mary Meskan
- Investigators
- Not Provided