RecruitingNot ApplicableNCT06689865

Innovations in Hearing Accessibility and Technology (IHAT) Study

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


Sponsor

University of Colorado, Denver

Enrollment

280 participants

Start Date

Nov 13, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 40 Years

Inclusion Criteria6

  • 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

Exclusion Criteria5

  • 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 score lower than 25 on the MOCA
  • Non-English speaking as it may impact the ability to complete our test battery

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Interventions

DEVICEHA-HCP

Prescription hearing aid fit by a hearing healthcare professional using audiology best practices.

DEVICEOTC-HCP

Over-the-counter hearing aids fit by a hearing care professional using audiology best practices.

DEVICEOTC-R

OTC fit to an individual using some best practices via remote consultation.

DEVICEOTC-SF

Self-fit OTC hearing aids without any clinical support from HCPs.


Locations(2)

University of Colorado School of Medicine

Aurora, Colorado, United States

University of Colorado Boulder

Boulder, Colorado, United States

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NCT06689865


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