Innovations in Hearing Accessibility and Technology (IHAT) Study

Last updated: November 15, 2024
Sponsor: University of Colorado, Denver
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hearing Loss

Medical Prosthetics

Deafness

Treatment

HA-HCP

OTC-HCP

OTC-SF

Clinical Study ID

NCT06689865
23-2351
R01DC021653
  • Ages > 40
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Adult onset, bilateral, mild-to-moderate sensorineural hearing loss documented byaudiological 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

Exclusion

Exclusion Criteria:

  • Hearing loss that is too severe for OTC HAs

  • Middle ear disorders or conductive pathology present

  • Asymmetrical hearing loss

  • Diagnosed neurological condition such as dementia or Parkinson's disease or a scorelower than 25 on the MOCA

  • Non-English speaking as it may impact the ability to complete our test battery

Study Design

Total Participants: 280
Treatment Group(s): 4
Primary Treatment: HA-HCP
Phase:
Study Start date:
November 13, 2024
Estimated Completion Date:
March 31, 2029

Study 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.

Connect with a study center

  • University of Colorado School of Medicine

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • University of Colorado Boulder

    Boulder, Colorado 80305
    United States

    Active - Recruiting

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