What are Over-the-Counter Hearing Aids (OTCs)?

Over-the-Counter (OTC) hearing aids are hearing devices that are bought online or in stores. To be eligible, the user must be 18 years or older and have mild to moderate hearing loss. The user is responsible for fitting, adjusting, and maintaining the devices, and they do not need a hearing test to purchase these devices. Although a hearing test is not required, it is highly recommended to determine the status of the hearing. It is important to recognize that all hearing losses are not the same. An audiologist or hearing aid specialist can provide a hearing exam and services to get a deeper understanding of the hearing loss you are specifically dealing with. The goal of OTCs is to be less expensive than hearing devices purchased through a provider, and will typically be sold from $300 to $600 per device. The issue with most OTCs is that they are typically less advanced than hearing devices offered through a provider, and they are considered to be amplifiers.

FDA Regulations

In 2017, the Food and Drug Administration (FDA) Reauthorization Act pushed for the FDA to provide a hearing device that could be more affordable for consumers and other government agencies in the United States. In October 2022, the FDA rolled out this act. However, there are rules that were established to monitor these devices.


1. The devices have a limit to how loud they can be

2. Labeling is required on the outside and inside of the box

3. Requirements established for sales

Am I a Candidate for Over-the-Counter Hearing Devices (OTCs)?

OTC devices are only approved for adults aged 18 and older who have a mild to moderate hearing loss. It is highly recommended to receive a hearing evaluation from a hearing professional (audiologist or hearing aid (specialist) to determine if your hearing falls within the mild to moderate category. Some questions you can ask to determine if you are having hearing difficulty and may benefit for OTC devices are:


• Do I struggle in quiet, one-on-one situations?

• Is my TV difficult to hear and if I increase the volume does it make it easier to hear (levels are slightly loud for others)? 

• Do you have difficulty listening in certain situations that with a little increased volume you would be able to hear the conversation clearly?

If you answered yes to one or more of these questions, you may have a mild hearing loss. However, these are often the complaints of those who have more than a moderate hearing loss. All in all, OTC devices are designed to make hearing devices more affordable for those who need a little bit of volume to better live their day-to-day activities. However, they could be difficult to maintain and properly adjust. If there is an issue within the device, you might not be able to bring them to your local provider to fix. In addition, they may not be fit to your needs and your specific hearing loss, resulting in inadequate hearing care. To best determine if this is the option best for your hearing needs, a hearing evaluation from a professional should be your first step.