hearing aids

FDA Finalizes Over-the-Counter Hearing Aids

On August 17th, 2022, the U.S. Food and Drug Administration issued a rule to improve access to hearing aids for all Americans. This rule created a new category of over-the-counter (OTC) hearing aids with the intent to drastically lower the cost of these medical devices.

The OTC hearing aids are made for those individuals with mild to moderate “hearing impairment” that are over the age of 18 years. The rule will allow those that fit into this category to order certain types of “air-conduction” hearing aids online, or even to pick them up in stores. Now folks will be able to get hearing aids without a medical examination or a prescription.

The ground breaking rule is expected to considerably lower the cost of all hearing aids. The objective of the ruling from the Biden Administration is to expand healthcare by making necessary healthcare affordable to all Americans. It is estimated by the National Institute on Deafness and Other Communication Disorders that almost 30 million adults in the U.S. could benefit from getting some form of hearing aid.

The ruling was a long time coming. In 2015 under former President Barack Obama, an advisory council was formed and recommended the creation of a “new category of hearing aids.” In June of 2021, President Joe Biden issued an executive order trying to promote competition in the American Economy, and specifically calling for the FDA to create steps to allow OTC hearing aids. Finally, in October 2021, the FDA proposed a preliminary rule and after receiving more than 1000 public comments from a variety of stakeholders issued their final ruling just weeks ago. The effective date for this ruling is 60 days after being published in the Federal Registry, which will be late October 2022. Meaning, millions of Americans could have access to hearing aids without a doctor's prescription as early as next month.

To learn more about the ruling visit this link.

To read the final rule visit: https://www.federalregister.gov/documents/2022/08/17/2022-17230/medical-devices-ear-nose-and-throat-devices-establishing-over-the-counter-hearing-aids