NCT06689865

Innovations in Hearing Accessibility and Technology (IHAT) Study

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 280 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The aim of the proposed project is to evaluate the effectiveness of emerging over-the-counter (OTC) service delivery models with the gold standard traditional prescription hearing aids fit by hearing care professionals (HCP) using audiology best practices. OTC service delivery models include OTC HA fit to individual users using best practices with in person HCP support (OTC-HPC), via remote consultation (OTC-R) and self-fit OTC HAs without any clinical support (OTC-SF). The study will use a prospective four-arm randomized controlled trial design with longitudinal repeated measures.

Conditions

• Hearing Loss
• Hearing Aids
• OTC Hearing Aids

Interventions

Type	Name	Description
DEVICE	HA-HCP	Prescription hearing aid fit by a hearing healthcare professional using audiology best practices.
DEVICE	OTC-HCP	Over-the-counter hearing aids fit by a hearing care professional using audiology best practices.
DEVICE	OTC-R	OTC fit to an individual using some best practices via remote consultation.
DEVICE	OTC-SF	Self-fit OTC hearing aids without any clinical support from HCPs.

Timeline

• Start date: 2024-11-13
• Primary completion: 2028-12-31
• Completion: 2029-03-31
• First posted: 2024-11-15
• Last updated: 2024-11-19

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study