Innovations in Hearing Accessibility and Technology (IHAT) Study for Hearing Loss

This study is looking at different ways to help people with mild to moderate hearing loss using hearing aids. Researchers want to compare traditional prescription hearing aids, fitted by a hearing specialist, with several types of over-the-counter (OTC) hearing aids. These OTC options include those fitted by a specialist, fitted remotely, or self-fitted without professional help. The study will look at how each type affects your hearing, daily experiences, thinking skills, and brain activity. They also want to understand who prefers each option, what helps or hinders these choices, and the costs involved. You can join if you are 40 or older, have mild to moderate hearing loss in both ears, and haven't used hearing aids for more than 3 months. The study aims to enroll 280 participants, but its current status is unclear.

Study design
This study is a randomized controlled trial with four groups. It plans to enroll 280 participants to compare different hearing aid fitting methods.
What's involved
You would be randomized to one of four groups and have your hearing aid benefit measured at the start, after 6 months, and after 12 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months after receiving their intervention.

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NCT06689865

Innovations in Hearing Accessibility and Technology (IHAT) Study

Recruiting
NAAges 40+InterventionalTreatment
University of Colorado, Denver
~280 participants
Updated 2024-11-19 on ClinicalTrials.gov
What's tested:HA-HCPOTC-HCPOTC-ROTC-SF

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Abbreviated Profile of Hearing Aid Benefit (APHAB)
Measured over T0 = Baseline, T1 = 6 months post intervention, T2 = 12 months post intervention
Hearing Loss
Hearing Aids
OTC Hearing Aids
2 sites across 1 states
Colorado2
  • Vinaya Manchaiah, AuD, MBA, PhD · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver
  • Anu Sharma, PhD · PRINCIPAL_INVESTIGATOR · University of Colorado, Boulder

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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
  • Abbreviated Profile of Hearing Aid Benefit (APHAB)T0 = Baseline, T1 = 6 months post intervention, T2 = 12 months post intervention

    It is a 24-item self-reported measure of hearing disability and hearing aid benefit. It includes four subscales that address different listening challenges: ease of communication, reverberation, background noise, and aversiveness of sounds, with each subscales comprising six items. The ease of communication, reverberation, and background noise primarily measure challenges related to speech communication. The global score on the APHAB is the average of these three subscale scores. The hearing aid benefit is calculated by comparing the difficulty level reported without amplification (unaided) to the difficulty level with amplification (aided). Scores range from 1% to 99%, with higher scores indicating greater perceived hearing difficulty.