Effectiveness Trial to Examine the Emerging Service Delivery Models for Over-the-Counter (OTC) Hearing Aids

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The research will explore outcomes of different service delivery models of over-the-counter (OTC) hearing aids by comparing them to prescription hearing aids fitted by specialists in individuals with mild to moderate hearing loss. The investigators will examine how each type affects users' experiences, behavior, thinking skills, and brain activity related to hearing. Additionally, the study will focus on what types of people prefer each hearing aid option, what helps or hinders these choices, and compare the costs of four different service options. This approach will help transition from research findings into real-world practice, providing useful information for healthcare providers and policymakers about OTC hearing aid options.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• Adult onset, bilateral, mild-to-moderate sensorineural hearing loss documented by audiological evaluation

• Aged 40 years or older

• No previous HA experience greater than 3 months

• Able to read and understand patient education materials

• Willing to be randomized to one of the four groups, and

• Owns a smartphone

Locations
United States
Colorado
University of Colorado School of Medicine
RECRUITING
Aurora
University of Colorado Boulder
RECRUITING
Boulder
Contact Information
Primary
Research Service Professional
ihat@cuanschutz.edu
303-724-8465
Backup
Preeti Pandey, PhD
preeti.pandey@cuanschutz.edu
Time Frame
Start Date: 2024-11-13
Estimated Completion Date: 2029-03-31
Participants
Target number of participants: 280
Treatments
Active_comparator: HA-HCP
Experimental: OTC-HCP
Experimental: OTC-R
Active_comparator: OTC-SF
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
Leads: University of Colorado, Denver

This content was sourced from clinicaltrials.gov