NCT06689865 Innovations in Hearing Accessibility and Technology (IHAT) Study
| NCT ID | NCT06689865 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Colorado, Denver |
| Condition | Hearing Loss |
| Study Type | INTERVENTIONAL |
| Enrollment | 280 participants |
| Start Date | 2024-11-13 |
| Primary Completion | 2028-12-31 |
Trial Parameters
Eligibility Fast-Check
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Brief 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 Criteria: * 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 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 score lower than 25 on the MOCA * Non-English speaking as it may impact the ability to complete our test battery