Improving Access and Affordability of Adult Hearing Healthcare

Part of paid clinical trials in Tuscaloosa, Alabama.

Sponsor
University of Alabama, Tuscaloosa
Study ID
NCT04671381
Status
Recruiting
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Conditions

  • Hearing Loss

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Hearing Evaluation — BEHAVIORAL
    Behavioral thresholds for pure tones will be conducted along with speech perception measures.
  • Over-the-Counter Hearing Aid (OTC HA) Fitting and Orientation — DEVICE
    Study participants will be fitted with binaural OTC HAs in addition to receiving information on how to use and care for their devices.
  • Four Weeks of Aural Rehabilitation — BEHAVIORAL
    Participants will receive four weeks of information sessions to help them adjust to their over-the-counter hearing aid and their hearing loss.
  • Provision of Over-the-Counter Hearing Aids — DEVICE
    Study participants will receive binaural OTC HAs. Participants will fit their OTC HAs based on manufacturer guidelines without the help of an audiologist.

Study Details

This project will address quality of care issues associated with hearing loss in adults who have mild-to-moderate hearing loss and who have no access to hearing healthcare. Through the use of three different interventions involving over-the-counter hearing aids, it will lead to options that will increase access and affordability of hearing healthcare for adults with mild-to-moderate hearing loss.

Key Dates

Start date
Jan 1, 2021
Status verified
Oct 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
210 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Audiology Best Practices plus Aural Rehabilitation (ABP+AR)
    This experimental group will receive a hearing evaluation, an over-the-counter hearing aid fitting and orientation, and four-weeks of an aural rehabilitation program conducted by specially-trained community health workers. Additionally, these adults will complete pre- and post-questionnaires and speech perception testing.
  • Active Comparator: Audiology Best Practices (ABP)
    This comparison group of adults with hearing loss will receive a hearing evaluation and over-the-counter hearing aid fitting and orientation. The aural rehabilitation program will not be provided initially. These participants will complete pre- and post-questionnaires and speech perception testing.
  • Active Comparator: Over-the-Counter Only (OTC-Only)
    This comparison group of adults with hearing loss will receive a hearing evaluation. They will be provided with over-the-counter hearing aids but the audiologist will not assist with fitting the aids or providing an orientation. This arm mimics what would happen when a consumer privately purchases over-the-counter hearing aids. They will complete pre- and post-questionnaires and speech perception testing.

Primary Outcome Measure

Measuring Change in the Hearing Handicap Inventory for Elderly (HHIE) Outcomes [ Time Frame: A baseline outcome will be obtained prior to over-the-counter hearing aid fitting. Outcomes will be measured at weeks 4 to 7 of intervention, during week 14 of the intervention, and through study completion, or 1 assessment each year. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of AlabamaTuscaloosaAlabama35487
Marcia J Hay-McCutchoen, PhD
[email protected]
205-348-4572

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By research site
The University of Alabama· Tuscaloosa, AL

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