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Over-the-Counter Hearing Aids: An Overview

Over-the-Counter Hearing Aids: An Overview


If you’re one of the many Americans for whom hearing aids serve a vital role in your day-to-day life, there are some significant changes coming to the hearing aid industry which might affect you. People choose a hearing aid for many reasons, most of which boil down to seeking better connections with friends and family, and ensuring those connections continue after they begin to lose their ability to hear.

In the past, the FDA has closely regulated hearing aids, required their purchase and fitting to occur only through a licensed hearing health care professional. However, recent legislation working its way through congress may change that. If the Over the Counter Hearing Aid Act becomes law, it will, for the first time, allow the sale of hearing aids over the counter (OTC), completely without the input of a hearing healthcare professional.

While some devices such as these have been in the marketplace for years, they’ve been required to be called “personal sound amplifiers” vs. hearing aids. While the two function similarly at the most basic level – they both amplify sound for the wearer – a true “hearing aid” could only be obtained through an audiologist or hearing aid fitter.

If signed into law, the new legislation will allow these devices to be called “hearing aids” and to be sold without prescription or consultation of any kind.

Legislation Status

So how soon can you expect this change? There are a few hurdles to cross before you can buy your hearing aids with your cold medicine. In early August, the Senate passed the legislation that paves the way for making over the counter hearing aids a reality. Under the proposed legislation, the FDA will have three years to create a new regulatory category for these products, and to set up the appropriate regulations to ensure appropriate product labeling, and that the products themselves meet specific safety, consumer and manufacturing standards.

As you might expect, there are many in favor and against the legislation, with both groups offering valid points.


Advocates of OTC hearing aids include the Hearing Loss Association of America (HLAA), the nation’s largest organization for people with hearing loss. HLAA believes that lower cost hearing aid alternatives will significantly broaden access to a critical hearing health product previously unavailable to many who either can’t afford or are unwilling to pay the cost of traditional hearing aids.

HLAA believes this change may accelerate hearing aid adoption of hearing aids by those who are newly experiencing hearing loss. With the average person waiting 7-10 years between when they first need a hearing aid and when they get one, HLAA reasons people with a new hearing loss will have a much better change at maintaining social and familial connections in the earliest stages of their hearing loss.


This legislation is also supported by those providing hearing health care, albeit with some important caveats. For example, both the American Academy of Audiology and the Academy of Doctors of Audiology, want to ensure all OTC hearing aids are clearly labeled for use by only those with mild hearing loss. They reason that as hearing loss becomes greater, the complexity of the hearing instruments and the need for them to be tuned to the needs of a particular wearer become much more important.

These groups also want to ensure that OTC instruments are only authorized for use by those over the age of 18, and that they carry stringent guidelines on how the devices work. This is important to ensure that any device that amplifies sound doesn’t inadvertently contribute to increased hearing loss.

These organizations and the hearing aid manufacturers themselves agree that the best patient outcomes come from a combination of a consultation with a hearing health care professional and a hearing aid tuned to the needs of that specific patient. Without both, these groups worry that poor outcomes from an OTC hearing aid may discourage users from seeing a hearing health care professional in the future, thereby making the situation worse.


As you consider options for you or a loved one, keep an eye on this legislation and the regulations as they develop. And whichever direction you’re considering, be sure that you explore all of your options fully, consult a knowledgeable source and select the device that is right for your specific situation. 

Additional Resources

Hearing Loss Association of America’s statement on OTC hearing aids.

A study by AARP comparing traditional hearing aids and the OTC variety.

Information on the legislation working towards becoming law.

American Academy of Audiology’s statement on OTC hearing aids.

Academy of Doctors of Audiology’s statement on OTC hearing aids.

Posted by NJAdmin on Sep 20, 2017