Comparing over-the-counter and prescription hearing aids for better hearing access
Effectiveness Trial to Examine the Emerging Service Delivery Models for Over-the-Counter (OTC) Hearing Aids
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 280 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 2 sites (Aurora, Colorado and 1 other locations) |
| Trial ID | NCT06689865 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with severe hearing loss, middle ear disorders, or neurological conditions may not benefit from this study.
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 performed: Other studies have shown promise in evaluating OTC hearing aids, but this specific approach comparing multiple service delivery models is relatively novel.
Eligibility criteria
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 this trial is running
Aurora, Colorado and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.