Innovations in Hearing Accessibility and Technology (IHAT) Study

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT06689865
Status
Recruiting
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Conditions

  • Hearing Aids
  • Hearing Loss
  • OTC Hearing Aids

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 13, 2024
Status verified
Nov 2024
Primary completion
Dec 31, 2028
Completion
Mar 31, 2029

Study Design

Enrollment
280 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: HA-HCP
  • Experimental: OTC-HCP
  • Experimental: OTC-R
  • Active Comparator: OTC-SF

Primary Outcome Measure

Abbreviated Profile of Hearing Aid Benefit (APHAB) [ Time Frame: T0 = Baseline, T1 = 6 months post intervention, T2 = 12 months post intervention ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Colorado School of MedicineAuroraColorado80045
Research Service Professional
[email protected]
303-724-8465
Vinaya Manchaiah, AuD, MBA, PhD (PRINCIPAL_INVESTIGATOR)
University of Colorado BoulderBoulderColorado80305
Research Service Professional
[email protected]
303-724-8465
Anu Sharma, PhD (PRINCIPAL_INVESTIGATOR)

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University of Colorado School of Medicine· Aurora, COUniversity of Colorado Boulder· Boulder, CO

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