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.