PROJECT SUMMARY
Age related hearing Loss (ARHL) is one of the most common chronic conditions affecting nearly one third of
the world's population over 60 years. Hearing aids (HAs) are the most commonly used and effective treatment
for people with ARHL. However, hearing aid uptake is low with only one in 4 people with hearing loss using HA
in high-income countries. This low uptake has been attributed to several multilevel factors including
awareness, high cost of the device, stigma, and perceived need. To address accessibility and affordability
issues with HAs, the U.S. Congress passed a new Over-the-Counter Hearing Aid (OTC HA) act in 2017. In
August 2022, the FDA finalized this legislation creating a new OTC HA category, which allows consumers to
purchase a HA without consulting a hearing care professional (HCP), significantly reducing the cost of these
devices. Unlike a traditional gold standard HA acquisition model where users need an in-person consultation
with HCPs to obtain prescription hearing aids, OTC HA do not have any requirements for consultation with
HCPs. In anticipation of OTC HA, several new service delivery models for HA provision have become evident
in the US. These include: OTC HA fit by a HCP using audiology best practices (OTC-HCP), OTC HA fit to
individual users using some best practices via remote consultation (OTC-R), and users purchasing self-fit OTC
HAs without any clinical support from HCPs (OTC-SF). These new service delivery models, if proven effective,
are likely to improve accessibility and affordability of HAs. However, concerns remain about their safety and
unproven efficacy given that these models are newly emerging.
The overall aim of the proposed project is to evaluate the comparative effectiveness of emerging OTC service
delivery models (OTC-HCP, OTC-R, OTC-SF) with the gold standard traditional HA-HCP model. We propose a
prospective four-arm randomized controlled trial (RCT) design with longitudinal repeated measures. This trial
will be a type 1 hybrid effectiveness-implementation study in which we will simultaneously examine the
implementability of the different service delivery models. Aim 1 will focus on comparing the effectiveness of HA
intervention delivered via four service delivery models (i.e., HA-HCP, OTC-HCP, OTC-R, and OTC-SF) using
self-reported, behavioral, and cognitive outcomes in an RCT. In the same study, Aim 2 involves comparing the
neurophysiologic outcomes between the HA service delivery models. Finally, Aim 3 focuses on optimizing
implementability of OTC HA service delivery from multiple multilevel perspectives. The proposed research is
conducted by a multidisciplinary team with expertise in audiology, cognition, neuroplasticity, health information
technology, implementation science, digital hearing, qualitative and mixed methods approach, and healthcare
economic. Results of our study will provide an urgently needed detailed examination of the effectiveness of
emerging service delivery models for OTC HAs compared to the traditional gold standard HCP model for adults
with mild-moderate ARHL informing clinical practice and policy recommendations.
