The technical medical terms can be a bit tricky to navigate when it comes to hearing aids. We want you to be confident that you're getting a high-quality medical device when choosing your hearing aid.
In this article, we'll discuss:
What are over-the-counter hearing aids?
Over-the-counter (OTC) hearing aids are hearing aids designed to treat those 18 and older with mild to moderate hearing loss. They can be fit without a prescription or the help of a hearing healthcare professional. OTC hearing aids are regulated as Medical Devices by the FDA and must meet strict guidelines to be registered with the FDA as an OTC hearing aid.
What's the difference between FDA-registered and FDA-approved?
All medical devices sold in the U.S. must be registered with the FDA, or "FDA-registered." As Class I medical devices, hearing aids must be FDA-registered.
Some devices, such as Class III devices, need FDA approval. FDA approval means that the FDA has decided the benefits of the approved item outweigh the potential risks for the item's planned use. This term is more commonly applied to drugs and medical procedures than hearing aids.
At this time, the FDA does NOT approve hearing aids, and no one can claim that a hearing aid is FDA-approved.
What is 510(k) FDA approval?
This is where things can get confusing. If hearing aids are “self-fitting,” they are class II and must obtain 510(k) clearance from the FDA. This can also be referred to 510(k) FDA approval. This lengthy process requires medical device manufacturers to submit technical, safety, and performance information—including relevant clinical research—to the FDA.
In the case of MDHearing, the FDA required us to submit proof that our smart hearing aids are “substantially equivalent” to similar devices that the FDA has already approved.
Are PSAPs registered with the FDA?
A personal sound amplification product (PSAP) makes everything equally loud and does not have the frequency shaping needed for most hearing loss. Because they are not considered medical devices, they do not have to be registered with the FDA. In contrast, hearing aids are subject to a higher level of federal regulation, and programmed with different frequency responses to fit a wide range of hearing loss.