Prioritizing research on over-the-counter (OTC) hearing aids for age-related hearing loss

Abstract

Hearing aids are the most commonly used treatment for people with age-related hearing loss, however, hearing aid uptake is low, primarily due to high cost of the device, stigma, and a lack of perceived need. To address accessibility and affordability issues, the U.S. Food and Drug Administration created a new over-the-counter (OTC) hearing aid category. Various types of hearing devices are available for both individuals with hearing loss and for those with normal hearing, as hearing enhancement devices. Hearing aids (i.e., prescription hearing aids, self-fitting OTC hearing aids, and pre-set OTC hearing aids) are regulated by the FDA. The purpose of this article is to (a) provide a summary of existing research on direct-to-consumer (DTC) hearing devices such as Personal Sound Amplification Products (PSAPs) that informs OTC service delivery models; (b) provide an update on existing and ongoing randomized controlled trials on currently marketed OTC hearing aids; and (c) highlight the need for immediate research on OTC hearing aids and service delivery models to inform policy and clinical care. It remains to be seen what effect OTC hearing aids have on improving the uptake of hearing aids by individuals with mild-to-moderate hearing loss. However, there is scant research on all aspects of OTC hearing aids that are currently on the market. We conclude that high quality independent research must be prioritized to supplement evidence provided by the OTC hearing aid manufacturers for regulatory approval purposes.

A New Service Delivery Model for Hearables

“…Traditional practitioner-delivered models involve visiting an audiologist or hearing aid dispenser for a hearing assessment, discussion of intervention options, fitting with the appropriate device/s if indicated, and follow-up support at varying intervals. 3,4 OTC product sales are available without a prescription and can be provided alongside evaluation and support by a hearing care professional. DTC products are sold directly to consumers through online retailers or other channels, without any hearing professional evaluation or guidance.…”

An Over-the-Counter Hearing Aid Clinical Trial in Rural Alabama: Project Design and Potential Implications for Pharmacy and Audiology Interprofessional Collaborations

“…Specifically, it will be necessary to examine how residents in rural communities deal with aspects of OTC HA purchase and use [ 9 , 21 ]. These consumers must self-identify their mild-to-moderate hearing loss and ensure that they have no other ear disorders that are contraindicative for hearing aid use.…”

“…Additionally, users will need to learn how to set their devices, how to care for and manage their hearing aids, and understand how to troubleshoot them when they are not working. These issues could be barriers to optimal benefit from OTC HAs [ 21 ]. Potentially, as suggested by Berenbrok and others, health care professionals, including pharmacists and pharmacy technicians, could be trained to provide basic hearing healthcare in these underserved communities to help mitigate the effects of hearing loss and improve access to hearing healthcare [ 11 , 14 , 15 , 21 ].…”

A novel consumer-centric metric for evaluating hearing device audio performance

“…Enhancing consumer-centricity in hearing healthcare, especially in approaches and communication, is crucial given the proliferation of DTC options (Brice et al, 2023;Manchaiah et al, 2023a). For example, there is a need for deeper understanding of consumer preferences and values to inform creation of products and channels tailored to their specific needs.…”