Over the last several months, the Attorneys General in Arizona, Louisiana, South Carolina, and Georgia issued warnings to be alert for scams or misleading sales tactics regarding Over-the-Counter (OTC) hearing aids. These warnings are an important reminder for consumers since the FDA (Food and Drug Administration) has not yet created the regulations governing the sale of OTC hearing aids.
In 2017, Congress passed legislation that required the FDA to create a new category of hearing aids that could be sold over the counter, or without the assistance of a hearing care professional, to those individuals with self-perceived mild to moderate hearing loss. The legislation set a date of August 2020 for the FDA to issue proposed regulations. The COVID pandemic taxed the resources at the FDA and the August deadline was not met. There are currently no OTC regulations from the FDA or FDA-approved OTC hearing aids that can be lawfully sold to consumers.
South Carolina Attorney General Alan Wilson stated, “Until the FDA finalizes their regulations on over-the-counter hearing aids, South Carolina consumers, especially seniors and military veterans, need to be mindful of unlawful and misleading products on the market. We are seeing more and more companies attempt to sell hearing aids over-the-counter that use the FDA logo or claim to be ‘FDA-registered,’ even though this new category of hearing aids has not been approved by the FDA.”
Consumers should also be aware that with the current lack of labeling requirements, sellers of OTC hearing devices are not obligated to inform consumers that their products are not intended for adults with severe hearing loss or for children and could potentially lead to serious and unnecessary health risks if used by these consumers.
In March 2021, FDA issued a bulletin warning firms that are misrepresenting their products as being “FDA approved” or “approved OTC devices”. The FDA does not issue registration certificates and has requested companies to stop showing certificates next to products that may imply FDA approval. The best way to ensure that a hearing aid is legitimate is to seek guidance from a medical professional.
The Hearing Industries Association strongly recommends that a consumer’s first step be to visit a hearing care professional to understand their unique hearing difficulties. The Attorneys General in the states that issued warnings have the following recommendations when seeking treatment for your hearing loss:
To learn more about how to choose a device that will be most beneficial to your hearing, check out the What to Consider When Looking for a Hearing Aid webpage and find a hearing care professional near you to discuss the safest treatment options.