Patient-Centered Hearing Aid Trial

Hearing Loss Clinical Trial

— P-CHAT  

Official title:

Comparison of Direct to Consumer Delivery Models for Hearing Devices

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04618315
• Other study ID #: HL-2019C1-16094
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: June 30, 2024

Study information

• Verified date: November 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 584
• Est. completion date: June 30, 2024
• Est. primary completion date: November 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 79 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Hearing Aids
• Hearing Loss

Intervention

Device:
• Hearing Aids
Receiver-in-the-ear hearing aids.

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Northwestern University Center for Audiology, Speech, Language, and Learning	Evanston	Illinois
United States	University of Texas Medical Branch	Galveston	Texas
United States	Sertoma Speech and Hearing Center	Palos Hills	Illinois

Sponsors (7)

Lead Sponsor	Collaborator
Northwestern University	Larry E. Humes, Leslie Rolph, Malini Patel, Mary Meskan, Tom Wardzala, Tracy Winn

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Duration of hearing aid use	Average hours of hearing aid use per day.	6 weeks
Primary	Profile of Hearing Aid Benefit	66-item self-assessment, disability-based inventory.	6 weeks
Secondary	Hearing Handicap Inventory for the Elderly	A self-administered scale to identify problems related to hearing loss.	6 weeks