Man looking at phone with hearing aid in ear

FDA Hearing Aid Regulation: What You Need To Know

Published: March 8, 2023

Updated: March 8, 2023

FDA hearing aids are medical devices that are regulated in the United States by the Food and Drug Administration (FDA). The FDA regulates hearing devices as registered medical devices in order to ensure that they are safe, effective, and affordable to those suffering from hearing loss. 

According to the FDA, there are over 30 million Americans who suffer from hearing loss, though other sources cite this closer to 48 million. Most Americans who do suffer from some form of hearing loss are unable to access treatment, believably due to financial barriers which is where FDA-regulated hearing aids can help those in need.

What is a hearing aid?

A hearing aid is designed to assist those with hearing loss to hear better or to even regain hearing almost completely in some cases. There are a number of different types of hearing aids that are aimed to solve a variety of problems in various ways. Here, we discuss FDA hearing aids that are specifically designed to treat those with mild to moderate hearing loss, such as those available through Lexie Hearing.

Hearing aids are not to be confused with Personal Sound Amplification Products (PSAPs) as these are not treated as medical devices and are not regulated by the FDA. PSAPs are also not intended to treat any form of hearing loss and are used to assist those who would like to amplify their surrounding sounds in recreational activities such as birdwatching or hunting. 

When discussing FDA hearing aids, it is important to note that these refer to hearing aids that can be purchased directly by a user, as well as those that are prescribed by a hearing healthcare professional. PSAPs are not classified as medical devices and do not meet the requirements for regulation by the FDA. 

Types of FDA Hearing Aids

Direct-to-consumer hearing aids

The first type of FDA hearing aid includes direct-to-counter (DTC) hearing aids, which are hearing devices that you can purchase directly from a manufacturer or retailer, such as Lexie Hearing. The FDA lists the below requirements for DTC hearing aids:


Type of Product Medical device

Electronic product

Intended Users People 18 years and older

For those with perceived mild to moderate hearing loss

Conditions for Sale Purchaser must be 18 years or older

No medical exam

No prescription

No fitting by audiologist

No need for licensed seller


DTC hearing aids are devices intended to treat mild to moderate hearing loss and do not require a medical examination, prescription, or fitment from a hearing healthcare professional, such as an audiologist. There are some restrictions to purchasing DTC hearing aids, such as the age of the person buying them, but they are intended to remove the financial barrier and offer accessible and affordable hearing aids. 

Man holding one hearing aid and a charger case

Prescription hearing aids


The second type of FDA hearing aids includes prescription hearing aids. These hearing aids need to be prescribed by a healthcare professional, typically after a formal examination of your hearing loss. After that, the healthcare provider will most likely conduct a fitting for your hearing aid, to ensure that it meets your needs. The FDA lists the below requirements for prescription hearing aids:


Type of Product Medical device

Electronic product

Intended Users People of any age, including those younger than 18 years

For people with any degree of hearing loss, including severe

Conditions for Sale Prescription needed

Must purchase from a licensed seller in some states


There are instances where a trained medical professional is essential to addressing your hearing loss but for many Americans, this is not always necessary, not to mention expensive. Prescription hearing aids are quite costly due to the increased price of the devices (typically) alongside the high-cost of medical bills incurred from visiting a healthcare professional. Adding to this, is the fact the hearing aid will most likely need to be adjusted by a healthcare professional, such as an audiologist, and will also need to be maintained through the same professional. 

Over-the-counter hearing aids

The FDA recently issued a final ruling on over-the-counter (OTC) hearing aids on August 16th, 2022, which states that hearing aids that meet the DTC regulations above can be sold in brick-and-mortar stores. The ruling is highly beneficial for those who have limited access to hearing healthcare, as it provides safe, effective, and affordable hearing aids for millions of Americans. You can look forward to purchasing OTC hearing aids from mid-October 2022.

You do not need a prescription, examination, or fitting from a hearing healthcare provider in order to purchase an OTC hearing aid, so long as you are over the age of 18. Since OTC hearing aids eliminate a lot of costs associated with traditional hearing aids, such as examinations and fitments, they are far more accessible and affordable. 

One of the greatest benefits of OTC hearing aids is that they are still regulated by the FDA so they are incredibly safe and effective to use. OTC hearing aids, such as those from Lexie Hearing, are far more affordable (ranging from $199 to $999) than traditional hearing aids (roughly $4500) which makes them more accessible. 

Lexie Hearing B2 hearing aids Powered by Bose wins inaugural USA Today Reviewed AccessABILITY Award 2023

Should FDA hearing aid regulation matter?

Absolutely! FDA hearing aid regulations ensure that whether you purchase a hearing aid directly from a manufacturer, retailer, or through a hearing healthcare provider, you get the best possible care for your hearing loss. FDA hearing aid regulations ensure that direct-to-consumer products are safe, effective, and affordable. 

Why choose Lexie Hearing?

Lexie Hearing offers a seamlessly integrated ecosystem of hearing aids that offer better hearing to those impacted by hearing loss. Lexie Hearing also offers full remote support by Lexie Experts® to ensure that you receive the best possible hearing experience and ongoing care. Lexie hearing aids are also fully regulated by the FDA and have been validated by audiology experts as well as others in the hearing healthcare industry. 

Lexie hearing aids offer full customization through the smartphone app which offers incredible versatility and functionality. You can set various environment settings for different situations, adjust specific bass, treble, and overall volume levels, giving you the ability to tune your hearing aid yourself to your personal sound preferences. Moreover, if you require any assistance with setting up your device, or are facing any other challenges, you have access to an unlimited support network of Lexie Experts® to assist you. 

Lexie hearing aids can be purchased directly online. To learn more about Lexie’s hearing solutions, contact us today or try our free online hearing test.

Image of post writer Lexie Hearing.

Written by Lexie Hearing



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