As you begin your search for hearing help, you may be overwhelmed by the amount of hearing aid technology available for purchase directly to your mailbox. Many of these online hearing aid companies provide detailed specifications of their product(s), often claim to save you money and time as compared to buying hearing aids through a professional, and claim to be FDA registered. Sound appealing? Hold on! Be sure to fully understand these companies’ claims before putting your hearing health in their hands.
Let’s start by noting that there are currently no over-the-counter (OTC) regulations from the FDA or FDA-approved OTC hearing aids that can be lawfully sold to consumers. The FDA is expected to publish proposed regulations on OTC hearing aids for public comment and review sometime this Fall, but they have not yet been released.
If you see “FDA registered”, keep in mind this statement from the FDA: “When a facility registers its establishment and lists its devices, the resulting entry in the FDA's registration and listing database does not denote approval, clearance, or authorization of that facility or its medical devices.”
In the United States, any company or establishment that is involved in the production or distribution of medical devices intended for commercial distribution is required to register annually with the Food and Drug Administration (FDA). There are specific categories of establishments or companies that must register and pay a fee annually for their registration based on what the company does or produces (i.e., manufacturer, repackager, exporter, etc.).
Some companies also incorrectly suggest “proof” of their affiliation with the FDA by displaying a Certificate of FDA Registration next to their product(s). Although these certificates often display the FDA logo and appear official, beware! The FDA does not issue device registration certificates. Companies using these false certificates are in violation of the Federal Food, Drug, and Cosmetic Act.
Companies that participate in the sale of hearing aids to hearing care professionals or consumers are classified by the U.S. Food & Drug Administration (FDA) as follows:
Each of these classifications have specific general or specific controls the manufacturer must adhere to in order to ensure the safety and effectiveness of the product.
Before a medical device, like a hearing aid, is sold to the public, a manufacturer must provide scientific evidence that demonstrates reasonable assurance that the device is safe and effective for its intended use. This is referred to as pre-market approval. If a device is substantially equivalent to a legally marketed device (one that is already available to consumers), manufacturers submit a 510K submission with data on the technical specifications and safety data that will allow the FDA to decide if the device can be cleared for market introduction.
The FDA provides online tools to check if a medical device has been FDA approved or cleared. You can search the Devices@FDA Database to see all approved and cleared devices, or the De Novo database to see if a medical device has been pre-approved by the 510k process.
We also encourage you to research the hearing aid seller on the Better Business Bureau website or other impartial consumer review site to see if others have had any experience with the company.
Hearing loss is a medical condition and is best treated by a hearing care professional (audiologist, ENT, or hearing aid specialist). It’s important to first know your degree or hearing loss (which sometimes varies by ear) and locate a device that is most appropriate for your unique hearing loss. The hearing care professional will be able to conduct some simple hearing tests, talk with you about what features are important to you, discuss trial periods so you can ensure the hearing aids are serving your needs, and provide long-term services and troubleshooting for your new devices. To speak with a hearing care professional near you, click here.
The Hearing Industries Association is the trusted voice on hearing health care for product innovation, public policy, patient safety and education.
