Clinical trial NCT04618315: P-CHAT: Comparison of Direct to Consumer Delivery Models for Hearing Devices
Official title: Patient-Centered Hearing Aid Trial: Comparison of Direct to Consumer Delivery Models for Hearing Devices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Aids
Hearing Loss
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2020-11-05
Enrollment: 584
Sex: ALL
Minimum age (years): 50
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three arm blinded randomized control trial.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Profile of Hearing Aid Benefit
timeFrame: 6 weeks
Secondary outcomes:
measure: Hearing Handicap Inventory for the Elderly
timeFrame: 6 weeks
Other outcomes:
measure: Duration of Hearing Aid Use
timeFrame: 6 weeks
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Evanston
country: United States
facility: Northwestern University Center for Audiology, Speech, Language, and Learning
state: Illinois
city: Palos Hills
country: United States
facility: Sertoma Speech and Hearing Center
state: Illinois
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
Study officials:
affiliation: Northwestern University
name: Sumitrajit Dhar
role: PRINCIPAL_INVESTIGATOR
References: