Emerging Service Delivery Models for Over-the-Counter Hearing Aids: A Hybrid Effectiveness-Implementation Trial - 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.
