New Rules Would Implement Senators’ Legislation to Spur More Competition in the Hearing Aid Market, Expanding Access and Reducing Costs

October 15, 2021 - WASHINGTON – Sens. Chuck Grassley (R-Iowa) and Elizabeth Warren (D-Mass.) called on the Food and Drug Administration (FDA) to issue new regulations for over-the-counter (OTC) hearing aids without delay. This comes after President Biden issued an Executive Order on Promoting Competition in the American Economy in accordance with their bill, the Over-the-Counter Hearing Aid Act, which was signed into law over four years ago.

“…it is our expectation that FDA will issue hearing aid regulations that are consistent with the law and reflect the intent of the Over-the-Counter Hearing Aid Act to expand consumer access to affordable hearing aids. Specifically, we hope that the rule does not contain any unnecessary restrictions that hinder access to these devices or their utility. The regulations must succeed in increasing competition, spurring innovation, and bringing down prices for consumers, while meeting the high standards of safety, manufacturing protections, and consumer labeling required of all medical devices,” the senators wrote.

More than 38 million Americans experience some degree of hearing loss. Older Americans are particularly affected, with nearly one in three people between the ages of 65 and 75, and around half of adults 75 or older reporting difficulty hearing. Yet, only 14 percent of people use hearing aids, primarily due to high costs. Hearing aids are not generally covered by health insurance or traditional Medicare and can cost thousands of dollars, making them prohibitively expensive for many Americans.

Grassley and Warren’s Over-the-Counter Hearing Aid Act removes outdated regulations blocking consumer access to affordable hearing aids and allows certain types of hearing aids to be made available over-the-counter to Americans with mild or moderate hearing loss. By introducing more competition into the hearing aid market, the law will provide consumers with more options at a price they can afford. The bill was passed into law in 2017 but FDA has not yet issued final regulations implementing the law. 

The senators have called on the FDA and the Department of Health and Human Services (HHS) to take action over the last four years. Most recently, Grassley pressed HHS Secretary Xavier Becerra on the FDA issuing OTC hearing aid regulations at a Senate Finance Committee hearing on the HHS FY 2022 Budget.

Full text of the letter can be found HERE.
Source: Senator Chuck Grassley