May 12th, 2021
Carson City, NV – Today, Nevada Attorney General
Aaron D. Ford warns Nevadans to be aware of misleading representations in the
marketing of some over-the-counter hearing aids. In 2017, the Food and Drug
Administration (FDA) relaxed restrictions on the sales of hearing aids. While
some companies are selling devices that can be purchased for a low price, many
of them are sound amplifiers and not FDA-approved medical devices.
Furthermore, some over-the-counter devices
may display “FDA Registration Certificates” that look like official government
documents and may even have the FDA logo. These certificates may be displayed
next to photos of the devices on the website, giving the impression that the
device has received FDA approval.
“Although these devices are easier to obtain
than traditional hearing aids, consumers should be aware that no
over-the-counter hearing aid has received FDA approval,” saidAG Ford. “Nevadans, always
remember to do your research before purchasing and to be suspicious of deals
that seem too good to be true.”
Medical device companies are required to
register and list their devices with the FDA. When a medical device company
registers and lists its devices, this indicates only that the company has
provided certain information to the FDA. However, it does not indicate FDA
approval, clearance, or authorization of the device. Information about listed
medical devices can be found on the FDA’s Medical Devices Databases page.
Traditionally, hearing aids are prescribed
and fitted by a hearing healthcare professional. Over-the-counter-devices may be
offered without consultation, and consumers may not receive warnings of the
risks associated with them. These risks include improper use of the device,
which could cause further harm to the user, and the inability to be screened
for underlying and contributing conditions, such as an ear infection requiring
medical attention, among other issues.
If you are considering buying a hearing aid,
the Office of the Nevada Attorney General’s Bureau of Consumer Protection
offers the following tips:
Consider making an
appointment with a hearing specialist who can give an opinion about the type of
device you should use;
Do not rely only
upon testimonials and good reviews on a company’s website. Research the company
through search engines, the Better Business Bureau, and other trusted sources;
familiarize yourself with the company’s return and refund policy prior to
purchasing a device; and
Be aware that the
FDA has not approved any over-the-counter hearing devices. These devices may
not work for those with significant hearing loss.
If you believe you have encountered a deceptive act regarding
the sale or marketing of a medical device, please file a complaint about your experience with our office.