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Emerging service delivery models for over-the-counter hearing aids: A hybrid effectiveness-implementation trial

This study plans to learn more about the effectiveness of hearing aids when provided in different methods (i.e., service delivery models). This study will compare over-the-counter (OTC) hearing aids that are self-fit, self-fit with remote support, fit by a hearing healthcare provider, and traditional prescription hearing aids.


Why this Research Matters

The goal of this study is to examine whether amplification with a pair of hearing aids provided through these different service delivery models can result in similar levels of self-reported benefit and improved brain function, speech perception, social-emotional well-being, and cognitive function.


Who can Participate

Adult

Inclusion criteria are (a) adult onset, bilateral, mild-to-moderate sensorineural hearing loss documented by audiological evaluation, (b) aged 40 years or older, (c) no previous HA experience greater than 3 months, (d) able to read and understand patient education materials, (e) willing to be randomized to one of the four groups, and (f) owns a smartphone Inclusion criteria are (a) adult onset, bilateral, mild-to-moderate sensorineural hearing loss documented by audiological evaluation, (b) aged 40 years or older, (c) no previous HA experience greater than 3 months, (d) able to read and understand patient education materials, (e) willing to be randomized to one of the four groups, and (f) owns a smartphone Exclusion criteria include (a) hearing loss that is too severe for OTC HAs, (b) middle ear disorders or conductive pathology present, (c) asymmetrical hearing loss, (d) diagnosed neurological condition such as dementia or Parkinson’s disease, or a score lower than 25 on the MOCA, and (e) non-English speaking as it may impact the ability to complete our test battery.


Study ID

Protocol Number: 23-2351

Meet the Team

Image of Principal Investigator

Vinaya Manchaiah, AuD, PhD

Principal Investigator


Locations