FDA Green-lights Over-the-Counter Hearing Aids

Last week, the Food and Drug Administration announced that it will now allow some hearing aids to be sold over the counter. 

The FDA announced at a briefing on Tuesday that those will mild to moderate hearing loss will now be able to directly purchase hearing aids from retailers without a prescription as part of an effort to increase availability and lower costs. 

Previously, even those with mild to moderate hearing loss needed a prescription to obtain a hearing aid, which required a medical exam often with a specialist. In addition to the added cost, this also increased the amount of time it took to get a hearing aid. 

The move was applauded by the Hearing Industries Association which represents hearing aid manufacturers.  

It is estimated around 38 million Americans suffer from mild to moderate hearing loss. 

FDA Commissioner Robert Califf said on Tuesday that over-the-counter hearing aids should be available as early as mid-October. The FDA’s ruling will clarify the regulatory requirements for hearing aids and personal sound devices (PSAPs) and it will take time for manufacturers to make sure they are meeting the new requirements.  

Califf said the FDA’s actions reflected its commitment to “safely lowering barriers to access” while providing consumers greater choices and lower prices. 

At Tuesday’s FDA briefing, Dr. Jeffrey Shuren, the director of the Center for Devices and Radiological Health, said the FDA’s new over-the-counter category applies only to certain “air conduction hearing aids” designed for adults over 18 with mild to moderate hearing loss.  

Air conduction hearing aids are the kind worn inside the ear or on the ear with an inside ear component and amplified sound into the ear canal. To prevent additional hearing loss, these devices will have sound limits.  

Dr. Shuren said hearing aids designed for severe hearing loss and those designed for people under 18 will remain prescription devices “to assure patient safety as well as effectiveness.”