Can We Hear You Now? FDA Gives Final Approval for Over-the-Counter Hearing Aid Sales

The Food and Drug Administration issued its final ruling today permitting over-the-counter sales of certain types of hearing aids. The ruling takes effect in 60 days. As FDA explains:

This action establishes a new category of over-the-counter (OTC) hearing aids, enabling consumers with perceived mild to moderate hearing impairment to purchase hearing aids directly from stores or online retailers without the need for a medical exam, prescription or a fitting adjustment by an audiologist. 

 

The rule is expected to lower the cost of hearings aids, furthering the Biden-Harris Administration’s goal of expanding access to high-quality health care and lowering health care costs for the American public. It is designed to assure the safety and effectiveness of OTC hearing aids, while fostering innovation and competition in the hearing aid technology marketplace. . . . 

 

Concurrently with issuing the final rule, the FDA also issued the final guidance, Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products (PSAPs), to clarify the differences between hearing aids, which are medical devices, and PSAPs, consumer products that help people with normal hearing amplify sounds.  

This could be "huge" for helping older adults.  I know that for many adults, not just the older adults I've worked with, it is terribly frustrating to be unable to hear properly.  Plus, I think that for some people, the ability to "try" a wider range of devices, without the time and expense of visiting specialized doctors, may facilitate "realism."   

At the same time, I worry that for some older adults, who actually are willing to see their hearing aid doctor, sometimes it was this doctor or specialist who caught the "real" problems, including the potential for mild cognitive impairment.  Could we miss those opportunities for more holistic health evaluations?