P-CHAT: Comparison of Direct to Consumer Delivery Models for Hearing Devices
- Conditions
- Hearing AidsHearing Loss
- Registration Number
- NCT04618315
- Lead Sponsor
- Northwestern University
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 584
- 50 - 79 years old.
- Mild or moderate hearing difficulty.
- Normal cognition.
- No prior hearing aid experience.
- Ability and willingness to pay privately ($650.00) for hearing aids
- Ability to read and understand English
- Symmetric hearing loss, no greater than moderate in degree
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Profile of Hearing Aid Benefit 6 weeks 66-item self-assessment, disability-based inventory. Participants answer the questionnaire twice, first prior to use of hearing aids and then after hearing aid use. The questionnaire is scored between 0-99% with higher values representing greater difficulty. Benefit is reported as the difference between the two scores with a higher number signifying greater benefit.
- Secondary Outcome Measures
Name Time Method Hearing Handicap Inventory for the Elderly 6 weeks A self-administered scale to identify problems related to hearing loss. The questionnaire has 25 items and can be scored between 0 and 100. The score after hearing aid use is subtracted from the baseline score (prior to hearing aid use) to obtain the benefit score. The higher the difference the greater the benefit.
Trial Locations
- Locations (4)
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
Northwestern University Center for Audiology, Speech, Language, and Learning
🇺🇸Evanston, Illinois, United States
Sertoma Speech and Hearing Center
🇺🇸Palos Hills, Illinois, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Northwestern Memorial Hospital🇺🇸Chicago, Illinois, United States