Comparing over-the-counter and prescription hearing aids for better hearing access
Official title: Effectiveness Trial to Examine the Emerging Service Delivery Models for Over-the-Counter (OTC) Hearing Aids
Run by University of Colorado, Denver · NCT06689865 · Data updated 2026-11-12
This study tests whether over-the-counter hearing aids work as well as prescription ones for people with mild to moderate hearing loss and looks at how they affect hearing experiences and costs.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 40 Years and up |
| Sex | All |
| Enrollment | 280 (estimated) |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 2 sites (Aurora, Colorado and 1 other locations) |
| Status | Recruiting |
| Started | November 13, 2024 |
| Main results expected | December 31, 2028 |
| Study ends | March 31, 2029 |
| Registry record updated | November 19, 2024 |
| Trial ID | NCT06689865 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 40 and older with mild to moderate sensorineural hearing loss who have not used hearing aids for more than three months.
✕Probably not a fit
Patients with severe hearing loss, middle ear disorders, or neurological conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This research evaluates the effectiveness of various service delivery models for over-the-counter (OTC) hearing aids compared to traditional prescription hearing aids fitted by specialists. The study will assess user experiences, cognitive impacts, and brain activity related to hearing among individuals with mild to moderate hearing loss. It will also explore preferences for different hearing aid options and analyze the costs associated with four distinct service models. The findings aim to inform healthcare providers and policymakers about the practical implications of OTC hearing aids.
Why it matters
Potential benefit: If successful, this study could enhance accessibility to hearing aids, improving the quality of life for individuals with hearing loss.
How similar studies have gone: Other studies have shown promise in evaluating OTC hearing aids, but this specific approach comparing multiple service delivery models is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
University of Colorado School of Medicine
Aurora, Colorado, United States Recruiting -
University of Colorado Boulder
Boulder, Colorado, United States Recruiting
Study contacts
- Principal investigator: Vinaya Manchaiah, AuD, MBA, PhD — University of Colorado, Denver
- Study coordinator: Research Service Professional
- Email: ihat@cuanschutz.edu
- Phone: 303-724-8465
Similar studies
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This trial will test whether taking clemastine while listening to engineered sounds helps people aged 45–65 with age-related central auditory processing disorder hear better in noisy places.
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This study will test whether 3D-printed hearing-aid ear tips are as comfortable, fit as well, and sound as good as standard ear tips for people with bilateral sensorineural hearing loss, and will compare how long each takes to make and how much each costs.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.