Innovations in Hearing Accessibility and Technology (IHAT) Study
NCT ID: NCT06689865
Last Updated: 2024-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
280 participants
INTERVENTIONAL
2024-11-13
2029-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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HA-HCP
HA-HCP
Prescription hearing aid fit by a hearing healthcare professional using audiology best practices.
OTC-HCP
OTC-HCP
Over-the-counter hearing aids fit by a hearing care professional using audiology best practices.
OTC-R
OTC-R
OTC fit to an individual using some best practices via remote consultation.
OTC-SF
OTC-SF
Self-fit OTC hearing aids without any clinical support from HCPs.
Interventions
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HA-HCP
Prescription hearing aid fit by a hearing healthcare professional using audiology best practices.
OTC-HCP
Over-the-counter hearing aids fit by a hearing care professional using audiology best practices.
OTC-R
OTC fit to an individual using some best practices via remote consultation.
OTC-SF
Self-fit OTC hearing aids without any clinical support from HCPs.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
ALL
No
Sponsors
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National Institute on Deafness and Other Communication Disorders (NIDCD)
NIH
University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Vinaya Manchaiah, AuD, MBA, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Anu Sharma, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Boulder
Locations
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University of Colorado School of Medicine
Aurora, Colorado, United States
University of Colorado Boulder
Boulder, Colorado, United States
Countries
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Central Contacts
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Facility Contacts
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References
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De Sousa KC, Manchaiah V, Moore DR, Graham MA, Swanepoel W. Effectiveness of an Over-the-Counter Self-fitting Hearing Aid Compared With an Audiologist-Fitted Hearing Aid: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2023 Jun 1;149(6):522-530. doi: 10.1001/jamaoto.2023.0376.
De Sousa KC, Manchaiah V, Moore DR, Graham MA, Swanepoel W. Long-Term Outcomes of Self-Fit vs Audiologist-Fit Hearing Aids. JAMA Otolaryngol Head Neck Surg. 2024 Sep 1;150(9):765-771. doi: 10.1001/jamaoto.2024.1825.
Knoetze M, Manchaiah V, De Sousa K, Moore DR, Swanepoel W. Comparing Self-Fitting Strategies for Over-the-Counter Hearing Aids: A Crossover Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2024 Sep 1;150(9):784-791. doi: 10.1001/jamaoto.2024.2007.
Other Identifiers
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23-2351
Identifier Type: -
Identifier Source: org_study_id
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