As we age, it’s common to experience hearing loss to one degree or another. In fact, over 35 million Americans have some form of hearing loss, from mild difficulty understanding others to profound hearing loss in both ears. Finding the right hearing aid isn’t just a matter of purchasing a sound amplification device. In fact, with the advances in technology over the past 20 years, hearing aids have become more sophisticated, giving users a personalized and more natural hearing experience.

The Food and Drug Administration (FDA) is a government agency that regulates the production of food and beverages, medications, and medical devices, both those made in the country and abroad, testing them according to standards for reliability, safety and performance. It also regulates hearing aids, medical devices designed to provide hearing assistance for individuals who suffer from mild to profound hearing loss in one or both ears. Hearing aids differ from over-the-counter (OTC) sound amplifiers in that manufacturers must demonstrate that the devices meet state and federal regulations regarding their effectiveness and safety regulations.

In this guide, we discuss some of the best hearing aids in-depth, plus provide information about how seniors can obtain FDA-registered hearing aids. We also evaluate three of the most popular and well-constructed devices and provide an overview of their features.

What Hearing Aids are FDA-Approved?

To be considered a hearing aid, as opposed to an over-the-counter sound amplifier, devices must meet FDA requirements. These FDA regulations stipulate that a hearing aid is  “any wearable instrument or device designed for, offered for the purpose of, or represented as aiding persons with or compensating for, impaired hearing.”  Regulations also cover labeling information and the device’s capability to safely deliver the services it claims to provide. The FDA considers unregulated, over-the-counter hearing devices to be Personal Sound Amplification Products (PSAPs), which only amplify sound rather than process it like hearing aids. 

If you’re in the market for a hearing aid to treat hearing loss, the only FDA-approved hearing aids are sold through a licensed audiologist or hearing specialist. PSAPs aren’t intended to treat hearing loss but rather amplify sound for individuals with normal hearing. Because PSAPs aren’t considered medical devices as per the FDA, there is no regulatory classification for these, nor extra requirements that manufacturers must follow. However, these OTC devices can be listed with the FDA to assure users that the devices meet safety standards and do not cause injury through intended use.

If you have moderate or significant hearing loss, you’ll most likely be better served by purchasing an FDA-approved device through an audiologists’ office. Hearing specialists conduct personalized evaluations of each patient, testing both ears to determine the extent of hearing loss and recommending the right fit for each individual. While hearing aids and audiologist visits may cost more than simply purchasing an OTC hearing device, some seniors may feel that the higher-quality product with more features and a personalized assessment of the extent of their hearing loss is worth the expense.

The Best FDA-Registered Hearing Aids

OTC hearing aid manufacturers can register with the FDA. There are guidelines, which aren’t as strict, regarding these devices. The FDA soon plans to have OTC devices registered, but these regulations are still in the drafting and approval process.

Below are two of the best hearing aids that are FDA-registered. While these companies may offer OTC models, the ones we’re featuring below offer remote care with a hearing specialist. 

Eargo 5

Eargo started in Silicon Valley, and the company is known for using sophisticated technology and a unique approach to sound amplification and fitted design. It’s known for having the most comfortable hearing devices, featuring a concealed-in canal (CIC) fit. Many users appreciate this feature, as the snug fit inside the ear canal ensures a more natural quality of sound and makes the hearing aids look nearly invisible or like a simple pair of earbuds.

The Eargo 5 is the company’s latest model, and it’s the most advanced, building on the technology used for existing devices. With the Eargo 5, users can recharge the device at home, which features a rechargeable Lithium-ion battery and a magnetic charging case for easy, contactless charging. Eargo has a proprietary application called Sound Match that allows users to conduct remote hearing screenings and tuning of their devices, allowing for micro-adjustments to make the experience more customized. This reduces the need for users to visit their audiologist’s office. The devices also have noise-reducing capabilities, ideal for noisy or crowded environments; plus, the two devices communicate with one another to provide more sensitive directional hearing and a more natural experience. Eargo also offers a 24-month warranty on the 5 devices.

Audicus Spirit

Audicus provides some of the lowest cost hearing aids on the market, which is a consideration for many seniors on a limited budget. The Audicus Spirit uses industry-leading technology for sensitive detection technology with remote care capability. The Audicus mobile app allows users to make adjustments to the hearing aid on the go, depending on their current environment and is included in the base price for Spirit. It’s Bluetooth-enabled, allowing owners to stream from supported media devices (phones, tablets, TVs and even cars) directly into the hearing aid for personalized sound.

Conclusion: Over-the-Counter versus FDA-Approved Hearing Aids

FDA-approved hearing aids are evaluated to a stricter standard than over-the-counter amplification devices. For many seniors, especially those who already have moderate hearing loss, the extra support provided by in-person or remote audiology care, including the ability to change the settings and sensitivity as the user’s needs change, may make them worth the expense. Plus, most audiologists stay up-to-date about advances in hearing technology and can inform you of new products or services as they come onto the market.

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