Effectiveness of an Over-the-Counter Self-fitting Hearing Aid Compared With an Audiologist-Fitted Hearing Aid: A Randomized Clinical Trial.
Karina C De Sousa, Vinaya Manchaiah, David R Moore...
https://pubmed.ncbi.nlm.nih.gov/37052929Actively Recruiting
Led by University of Colorado, Denver · Updated on 2024-11-19
280
Participants Needed
2
Research Sites
12 weeks
Total Duration
U
University of Colorado, Denver
Lead Sponsor
N
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborating Sponsor
Researchers are studying different ways to provide over-the-counter (OTC) hearing aids compared to traditional prescription hearing aids fitted by specialists for adults with mild to moderate hearing loss. The goal is to understand how each hearing aid option affects users' hearing experiences, behavior, thinking skills, and brain activity. The study also looks at which people prefer each type, what helps or hinders their choices, and compares the costs of four service delivery models. This information aims to help healthcare providers and policymakers apply research findings in real-world settings. The study compares four groups: prescription hearing aids fitted by hearing care professionals using best audiology practices, OTC hearing aids fitted by professionals in person, OTC hearing aids fitted via remote consultation, and self-fit OTC hearing aids without clinical support. This is a randomized controlled trial with repeated measures over time to assess the different service models. Participants aged 40 and older with mild to moderate hearing loss will join the study and be randomly assigned to one of the four groups. They will be evaluated at the start, then again at 6 months and 12 months after intervention using questionnaires and hearing tests. Researchers will measure hearing aid benefits, satisfaction, hearing difficulties, speech comprehension, and overall impression of change. The study will last at least one year, with ongoing monitoring of participants' hearing outcomes and experiences.
CONDITIONS
Innovations in Hearing Accessibility and Technology (IHAT) Study
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Initial fitting and adjustment period at baseline
Participants receive hearing aids fitted according to their randomization group, including prescription hearing aids by professionals or over-the-counter models with varying levels of clinical support.
1 baseline visit (in-person or remote depending on group)
Duration - 12 months
Participants are monitored to evaluate the effectiveness and satisfaction with the assigned hearing aids over time.
Follow-up visits at 6 months and 12 months post intervention
Total: 2 locations
1
University of Colorado School of Medicine
Aurora, Colorado, United States, 80045
Actively Recruiting
2
University of Colorado Boulder
Boulder, Colorado, United States, 80305
Actively Recruiting
R
Research Service Professional
P
Preeti Pandey, PhD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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Karina C De Sousa, Vinaya Manchaiah, David R Moore...
https://pubmed.ncbi.nlm.nih.gov/37052929Karina C De Sousa, Vinaya Manchaiah, David R Moore...
https://pubmed.ncbi.nlm.nih.gov/38990557Megan Knoetze, Vinaya Manchaiah, Karina De Sousa...
https://pubmed.ncbi.nlm.nih.gov/39052241