Embracing Change in Audiological Treatment: Over-the-Counter Hearing Devices

By Erin Miller

This article is a part of the July/August 2019, Volume 31, Number 4,  Audiology Today issue.

In October 2015, the President’s Council of Advisors on Science and Technology (PCAST) released a report to President Barack Obama titled “Aging America and Hearing Loss: Imperative of Improved Hearing Technologies.” In the report, the council informed the president that untreated age-related hearing loss is a significant national problem. The advisors provided recommendations to decrease cost; enhance innovation; and improve the convenience, capability, and use of devices for individuals with mild to moderate hearing loss.

Soon after, in June 2016, the National Academies of Science, Engineering, and Medicine (NASEM) released a report titled “Hearing Health Care for Adults: Priorities for Improving Access and Affordability.”

Both the PCAST and NASEM reports included a recommendation that the Food and Drug Administration (FDA) implement a class of over-the-counter (OTC) hearing devices. These reports—along with mounting evidence regarding the comorbidity of hearing loss and other health conditions including depression, cognitive decline, diabetes, and cardiovascular disease—amplified attention about adult hearing loss and the need to improve pathways to treatment and affordability.

Typically, it takes many years for the types of recommendations made in the PCAST and NASEM reports to become law. It took less than two years for this to occur for OTC hearing devices. The Food and Drug Administration Reauthorization Act (FDARA), signed into law in August 2017, included language that required the FDA to establish a new category of OTC hearing devices.

This federal law will permit consumers with self-perceived mild to moderate hearing loss to purchase OTC products without the involvement of a licensed hearing health-care professional. The law requires the FDA to publish proposed regulations for these devices by August 18, 2020, and once the regulations are drafted, to allow a period for public comment. Typically, public comments are accepted for 30 to 180 days, with the FDA required to publish final regulations within 180 days after the close of the comment period.

The last public update on the issue came from the FDA in July 2018, when the agency sent letters to manufacturers of hearing devices stating that, until the effective date of a final published regulation, OTC devices do not exist.