Joining Pharmacists on the Over-the-Counter Hearing Aid Journey

By Elaine Mormer and Lucas A. Berenbrok

This article is a part of the May/June, Volume 35, Number 3, Audiology Today issue. 

It has been many years since audiologists first got wind of over-the-counter (OTC) hearing aids coming to the marketplace. The topic emerged into the public eye during the Obama administration, when the President’s Council of Advisors on Science and Technology (PCAST) issued a report on hearing loss and technology. This report highlighted something that was no surprise to audiologists: “untreated age-related hearing loss is a major health and social problem” (PCAST, 2015). 

This report led to legislation that created the Food and Drug Administration (FDA) new regulatory category of OTC hearing aids in 2017 (FDA, 2017). After an open comment period ended in January 2022, the FDA published final regulations in August 2022 (FDA, 2022). On October 17, 2022, FDA-regulated OTC hearing aids became available for purchase in retail settings (FDA, 2022). Given that the law was passed, regulated, and implemented, we must now move forward and recognize that a new pathway to hearing-health care exists for our patients. This pathway is like other OTC drugs and devices not requiring the services of a health professional and can thus be described as hearing self-care.

Given what audiologists know about the complexity of hearing loss and personalized hearing solutions, it seems likely that collaboration with pharmacists would be welcome and could increase referrals to audiologists.

OTC Hearing Aids as a Self-Care Treatment

The World Health Organization defines self-care interventions as “tools that support the ability of individuals, families, and communities to promote health, prevent disease, maintain health, and cope with illness and disability with or without the support of a health worker” (World Health Organization, 2022). 

OTC hearing aids fit into this framework for self-care interventions. These products are designed and labeled for the purpose of a DIY (do it yourself) hearing solution. Since the 1970s, there has been a steady increase in the number of health conditions for which self-care interventions apply (Narasimhan et al, 2019). 

Many self-care products are sold at pharmacies, and pharmacists are considered a highly trusted resource for health information and support for nonprescription treatments for self-care. Pharmacists are highly educated and have a positive impact on a variety of health-related outcomes, particularly in rural locations (Fathima et al, 2013; Schimmelfing et al, 2017). 

In fact, 90 percent of Americans live within approximately five miles of a pharmacy (Berenbrok et al, 2022), making pharmacists one of the most accessible licensed health professionals in our country. The notion of providing guidance on the safe and effective use of OTC medications and products is not new for pharmacists. However, adding hearing aids to the existing mix of OTC products in pharmacies will no doubt present challenges as well as opportunities for collaboration and referrals to audiologists.