The 7 Best OTC Hearing Aids of 2023 | NCOA.org

OTC hearing aids are FDA-regulated medical devices that can be bought directly from the manufacturer. You don’t need a hearing exam, prescription, or appointment with an audiologist to purchase OTC hearing aids.

According to the FDA’s final rule on OTC hearing aids passed in August 2022, OTC hearing aids are appropriate for people over the age of 18 with perceived mild to moderate hearing loss.6

Amy Sapodin, a doctor of audiology in New York City, points out that availability of OTC hearing aids has the potential to help many people with hearing loss. “Early intervention is key for the long-term health of your auditory system,” said Sapodin. “The new category of OTC hearing devices is intended to increase accessibility and awareness for the need to treat difficulty hearing in its early stages, not just when it’s unlivable. The new ruling will, hopefully, be the impetus people need to prioritize hearing, as it is often one of the last on folks’ health care checklist. It will also remove barriers to access to hearing solutions for those who cannot afford prescription hearing aids.”

OTC hearing aids are not the same as personal sound amplification products (PSAPs). Unlike hearing aids, PSAPs magnify all sounds equally, are not designed to treat hearing loss, and are not regulated by the FDA.7

For more information, read our detailed overview of OTC hearing aids.

How do OTC hearing aids work?

OTC hearing aids have been made available for purchase by legislation the FDA passed in August 2022. The FDA’s final rule on OTC hearing aids created new regulations for hearing aids that can be purchased directly from the manufacturer, without the need for a prescription or in-person appointment with an audiologist.

Where to buy OTC hearing aids

OTC hearing aids began hitting stores in October 2022, and you can now buy them online and in stores that carry health care devices, such as Walgreens, Best Buy, and Walmart. Look for OTC hearing aids in the pharmacy section.

How are OTC hearing aids regulated?

The FDA has developed a set of regulations that apply to all OTC hearing aids in order to ensure their safety for adults with mild to moderate hearing loss.8 These regulations outline details like how OTC hearing aids can be labeled, the degree to which they can magnify sounds, and how far they can be inserted in the ear.

You may see labels on hearing aids regarding their FDA registration, approval, or clearance. Let’s take a look at each term to see what they mean.

FDA regulation

Products that are registered with the FDA have listed their manufacturing facility and provided information about their manufacturing process. Medical device companies in the United States are required to register with the FDA every year. FDA registration does not mean the FDA has tested a product or deemed it to be safe, nor does it imply FDA clearance or approval.9

OTC hearing aids that are not self-fitting (but instead have preset profiles you can select from) are designated by the FDA as Class I medical devices, meaning they pose little or no risk of harm when used according to the label instructions. These devices are typically only FDA-registered.

FDA clearance and approval

Self-fitting hearing aids, because they involve more detailed adjustments by the user, are Class II medical devices and require the manufacturer to submit clinical research findings, safety data, and performance information to prove their safety and efficacy.

Devices that successfully complete the process receive FDA clearance. You may also see this listed as 510(k) approval. You can look up any hearing aid brand to see which of its devices have undergone this process in the FDA’s database.10

Hearing aids that have received FDA 510(k) approval or are labeled as FDA-cleared have completed a more rigorous process than those that are FDA-registered only. FDA registration applies to the facility that makes the devices, while FDA clearance or approval applies to the devices themselves.