Retail Hearing Aid Stores

You have seen them—the endcap in the local discount or drug store with devices that are labeled as “hearing aids.” The price might range anywhere from $49.99 for a very basic sound amplifier to $899.00 for a product that is now classified by the FDA as an over-the-counter hearing aid. Despite the price point, they often all reside in the same display case, all posing as the same types of devices you would get at a private audiology practice. These devices may have a label that uses language like FDA Registered or FDA Certified with the FDA logo on the box. Is that the same thing as FDA approved, FDA cleared, or FDA authorized? The short answer is NO. There might be a host of monikers on devices, and even the devices that now fit into the FDA guidelines that were released in 2022 for over-the-counter hearings aids, all such products need to be examined carefully before you spend hard earned money on devices that will give you little benefit. For information on devices that do not fall under the new FDA guidelines, read on for additional information.

What does it mean when something is FDA Registered?
According to the FDA, “owners or operators of places of business that are involved in the production and distribution of medical devices intended for use in the United States are generally required to register annually with the FDA.”

It's important to understand that when a facility registers its establishment and/or lists its devices, it is simply that, a registration. The FDA requires this of all such businesses so that they know what businesses are operating in the U.S. and what products they are making and selling. The resulting entry in the FDA’s registration and listing database DOES NOT IN ANY WAY denote approval, clearance, or authorization of that facility or its medical devices.

Are there FDA Certificates? No.
Some retail store-based hearing aids will even include an FDA certificate in its packaging. What does this mean? When a business involved in the production and distribution of medical devices intended for use in the United States registers with the FDA, they do not receive a certificate from the FDA.

It's important to understand that the FDA DOES NOT ISSUE ANY TYPE of device registration certificates to medical device facilities. In addition, the FDA does not “certify” registration information for businesses that have registered and listed.

Misleading FDA Registration Certificates
Some firms sell medical devices in the United States alongside "FDA registration certificates," such as the sample certificate depicted here.

Example of a Fraudulent Certificate

These certificates often have the look of an official government document and may include the FDA logo. However, FDA does not issue device registration certificates.

Firms that misleadingly display certificates alongside information about and photos of a device for sale in the United States to imply review or approval by FDA of the device misbrand the device in violation of the Federal Food, Drug, and Cosmetic Act.

How Do You Know if the FDA Approved, Cleared, or Authorized a Medical Device?
The FDA provides several ways for you to check if the FDA approved or cleared a medical device or, as described below, if the FDA authorized the device to be used during a public health emergency.

You can search for FDA-approved or FDA-cleared products by device name or company name:

Go to the Devices@FDA Database.

In the Enter a search term in the space below field, type the name of the device or the company name. You can type the exact name of a specific device or a generic name for a category of devices (such as hearing aid or cochlear implant.

Click Search.

It is important to understand that a true hearing aid is a class II medical device and MUST be FDA approved and then programmed specifically for you based on the results obtained during a comprehensive hearing evaluation at a licensed audiology practice, ENT office or licensed hearing aid dispenser.

Even if a hearing aid purchased at a discount or drug store has instructions for taking an online hearing test at home and then emailing the results for “programming” by a “trained professional” this type of fitting of a hearing aid is inferior, at best, to the professional care you will get from a university-trained audiologist and is a danger, at worst, since improper amplification can result in damage to your ears. Additionally, hearing loss may result from a medical condition like a bacterial or viral infections or a tumor. By self-treating for hearing loss, these medical conditions go undetected.

Bear in mind, if a company resorts to presenting itself as something it’s not by slapping an FDA logo on the packaging and presenting misleading labels and wording, you should beware of the product.

What about the Over-the-Counter hearing aid designation that went into effect in 2022
Over-the-counter hearing aids are a new official designation that the FDA released official guidelines on in August 2022.

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From Frustration to Confidence: How Starkey Omega AI Helped a Veteran Reconnect with the Sounds of Life

July 3, 2026

For U.S. Navy veteran Petty Officer 3rd Class Niketa Willard, hearing loss wasn't just an inconvenience—it was affecting her work, her daily life, and her ability to fully engage with the world around her. Like many people with hearing loss, she didn't realize just how much she was missing until she experienced better hearing firsthand. The Patient's Hearing Challenges Niketa's hearing loss became most noticeable in two areas of her life: at home and at work. At home, she found herself missing everyday sounds she once took for granted. Whether it was birds singing in the distance, children playing nearby, or even the warning beep from her dog's training collar, many sounds had gradually faded from her awareness. At work, the challenges were even more significant. Niketa frequently communicates with contractors located around the world, often navigating different accents and fast-paced conversations during virtual meetings. "I was constantly asking people to repeat themselves," she recalls. "I relied on captions, recordings, and detailed notes just to make sure I understood what was being discussed." Why She Sought Help As communication became increasingly frustrating, Niketa realized it was time to find out what was happening with her hearing. What she discovered confirmed what she had been experiencing all along—her hearing difficulties were real, and they were significant. As a military veteran who worked around ammunition, flight decks, firearms, and other high-noise environments, Niketa believes her hearing loss is directly related to her years of service. "I was around a lot of things that go boom," she says. "I know my hearing loss came from my military days." Her Experience at Johnson Audiology One of the things that stood out most to Niketa was how she was treated throughout the process. "They listened to my concerns," she says. "I felt heard and seen." Rather than rushing through appointments, the team took time to understand her challenges, explain her test results, and help her find the right hearing solution for her lifestyle. "They treat you like a person—not just another number," Niketa explains. "The doctors really care. They take the time to teach you how to use the devices, explain what to expect, and make sure you're comfortable every step of the way." She also appreciated the ongoing support available after her fitting, including walk-in service hours and easy access to help whenever questions arise. Why She Chose Starkey Omega AI After evaluating her hearing needs, Niketa's audiologist, Dr. Anna Wade, recommended Starkey Omega AI hearing aids. The advanced technology offered features that supported both her professional and personal life, helping her hear conversations more clearly while reconnecting her with environmental sounds she had been missing. The devices also included sound therapy options that help her manage tinnitus, a common condition among veterans with noise-induced hearing loss. "When the ringing becomes bothersome, I can use the background sounds in my hearing aids to help distract from it," she says. "That feature has really helped." The Improvements She's Noticed The difference was immediate. One of Niketa's first realizations came while sitting on her patio with her dog. For the first time, she could hear the beep from his training collar and the sounds that had always triggered his barking. "I could hear everything he was hearing," she says. "The birds, people walking nearby, kids playing—sounds I didn't even realize I was missing." At work, the improvement has been equally dramatic. "I can hear people so much more clearly now," she explains. "I don't have to ask them to repeat themselves three or four times. It's been a game changer." The reduced communication strain has improved her confidence, productivity, and ability to learn and retain information during meetings. Advice for Others Considering Treatment For anyone putting off hearing treatment, Niketa has a simple message: "Take that step." She encourages others not to wait, even if they need time to plan financially for treatment. "It's worth it. It's a life-changing experience. You really have nothing to lose because you already can't hear. You have everything to gain." Ready to Hear What You've Been Missing? If hearing loss or tinnitus is affecting your work, relationships, or daily life, Johnson Audiology is here to help. Our experienced audiologists provide comprehensive hearing evaluations, personalized treatment recommendations, and access to advanced technology like Starkey Omega AI hearing aids. Schedule your hearing consultation today and discover what better hearing can do for you.