Many adults with hearing loss have no access to hearing healthcare due to a variety of factors1. One primary factor is that approximately 56% of counties across the US have no available audiological services. These counties are characterized by lower household incomes and older populations. Within some of these rural communities in Alabama, Hay-McCutcheon and colleagues found that adults with hearing loss did not know where to obtain services, travel distance to an audiologist was excessive, finances or insurance was lacking, some denied having hearing loss, and many did not know how to begin to address a hearing loss. Not addressing a hearing loss has significant implications for emotional well-being and mental health. Studies have found that hearing loss is associated with increased social isolation and loneliness. These conditions, in turn, can lead to cognitive decline. In addition to mental health, hearing loss has been associated with diabetes, affecting physical well-being. Considering the impact that hearing loss can have on general well-being, it is imperative that new models of care are developed to address this public health concern, especially for those living in rural and underserved communities, where access to hearing healthcare is limited. Addressing access to hearing healthcare for rural and underserved communities is a primary goal outlined in the 2016 National Academies of Sciences, Engineering, and Medicine document, Hearing Health Care for Adults: Priorities for Improving Access and Affordability10 and within the Notice of Special Interest for this application, Hearing Healthcare for Adults: Improving Access and Affordability (NOT-DC-21-001).
In an attempt to address the lack of hearing healthcare for adults, the FDA issued a Final Rule for OTC HAs in 2022. This rule allows adults who are 18 years of age or older with perceived mild-to-moderate hearing loss to purchase OTC aids without a medical exam, from an unlicensed seller, and without a prescription or fitting from an audiologist. Consequently, many adults without access to hearing healthcare now have the option to address their own hearing loss. Currently, these hearing aids can be purchased from retail stores, pharmacies, or online, and can range from approximately $200 per pair to up to $3000 per pair. However, for those who do not have geographical access to retail outlets, the internet, or who are not technologically astute, these potential solutions to hearing loss will remain elusive. Large retail chains are not easily accessible in rural communities, nor is access to the internet. To mitigate this problem, new care delivery models are needed to assist those with hearing loss across racial, educational, and economic lines. The study outlined in this proposal, where pharmacy technicians will be trained to assist rural populations with the provision of OTC HAs, is significant because it will be the first step for the development of a new care delivery model to increase access of hearing healthcare. Within the audiology field, it is not uncommon for support staff to be trained to assist with hearing assessments, such as newborn hearing screenings, elder care in hospitals, and hearing screenings for elementary school children. Educating technicians to assist pharmacists with the provision of OTC HAs, therefore, is a logical step to address hearing healthcare.
In rural communities, the pharmacy provides support to residents in a variety of ways. Pharmacists are trusted professionals who are trained to care for their patients and their medication-related needs. Community pharmacies have been referred to as untapped resources for public health. The pharmacy profession supports expanding roles for pharmacy technicians. Literature has suggested that their roles should be expanded to provide more point-of-care treatment, such as cholesterol and blood glucose screening, increasing duties associated with the technical aspects of pharmacy operations, and pharmacy administration duties. The development of a new care delivery model where the professions of audiology and pharmacy can work together to increase access to hearing healthcare in rural communities is highly significant.
Results from rigorous clinical trials conducted by Humes and colleagues in a largely white, highly educated, metropolitan college community demonstrated that adults with hearing loss can effectively set consumer driven (CD), or OTC, hearing aids independently. But data from these studies also suggested that adults were more satisfied with the hearing aids if they were given help setting the device. Over the past two years we have been conducting a clinical trial with OTC HAs (ID: NCT04671381) in West Central and South Alabama and unpublished preliminary data from 29 participants on a measure of hearing handicap found a large Cohen's d effect size of 0.91 when comparing adults who received no guidance setting their OTC HAs to those who received guidance after four weeks of OTC HA use. These data further stress the importance of developing care delivery models for rural communities to assist with the provision of OTC HAs.
Information from this study will provide the basis for interprofessional collaboration among audiologists, pharmacists, and pharmacy technicians for the provision of basic hearing healthcare in rural communities with older and poor populations. Also, the study will identify best practices for educating pharmacy technicians in the provision of OTC HAs in rural and communities. Importantly, these contributions will address an area of need outlined in the Hearing Healthcare for Adults: Improving Access and Affordability (NOT-DC-21-001), which is to increase access to hearing healthcare in diverse populations using innovative care delivery models.
