According to the FDA, hearing loss is more than just a problem that affects individuals -- it's a critical public health issue that can have a profound impact on quality of life. In the United States, an estimated 48 million people have some degree of hearing loss. And yet, only 20 percent of those who could benefit from hearing aids actually use them.
There are many reasons why people don't seek treatment for their hearing loss. For some, the cost of prescription hearing aids is simply too high. Others find the devices to be bulky and uncomfortable. And still others worry about how they will look or sound wearing hearing aids.
The good news is that all of these barriers are starting to disappear. In 2017, the United States Government and the Food and Drug Administration released new regulations that will for the first time.
At , we're excited about the potential of the over-the-counter hearing aid to help more people get the treatment they need. Starting in mid-October, we'll be opening an online shop that features the best products on the OTC hearing aid market paired with the expert guidance of our audiologists.
If you're considering an OTC hearing aid, here are some important facts you need to know:
What Are Over-the-Counter Hearing Aids?
Over-the-counter (OTC) hearing aids are a new category of hearing aids. Unlike similar prescription devices, an over-the-counter hearing aid is a device that can be purchased without a prescription from a licensed audiologist or hearing healthcare professional. Under the new FDA regulations, OTC hearing aids are only available for adults (18 years or older) with a perceived mild to moderate hearing loss.
This is different from personal sound amplification products (PSAPs), which are worn in or around the ear canal to improve hearing. While hearing aids are intended to treat impaired hearing, personal sound amplification products (PSAPs) are meant for individuals with normal hearing who want to amplify sounds in certain situations, for example, bird watching. PSAPs are regulated the same as other consumer electronics and not as medical devices, so the quality can vary widely. The FDA does not regulate PSAPs for safety and effectiveness like it does hearing aids. You should be careful not to keep the device on if the sound is very loud because you could damage your hearing over time.
Do Over-the-Counter Hearing Aids Actually Work?
Yes, they can work for someone who has a perceived mild to moderate hearing loss as long as they can self-fit and self-maintain the devices. In general, OTC hearing aids tend to be less expensive and have fewer features than their prescription counterparts.
The new OTC hearing aids are different in that they are regulated by the FDA and must meet certain criteria in order to be sold. Of course, your experience may vary depending on the severity of your hearing loss and the specific device you choose.
What Features Do Over-the-Counter Hearing Aids Offer?
While OTC hearing aids don't have all the bells and whistles of their prescription counterparts, they do offer some important features that can improve your hearing.
For example, most OTC hearing aids come with directional microphones that help you focus on the sounds you want to hear while filtering out background noise. Many also include automatic volume control, which adjusts the sound level based on your environment. And some even come with Bluetooth connectivity, so you can stream audio directly from your phone or other devices.
When Will OCT Hearing Aids Be Available Nationwide?
The US government issued the final rule on OTC hearing aids in August 2017, but the new FDA regulations will go into effect in mid-October, 2022, which is when the first batch of OTC hearing aids is expected to hit store shelves. However, it may take a few months for all manufacturers to get their products certified and for OTC hearing aids to be available nationwide.
In the meantime, you'll still be able to purchase an OTC hearing aid online from licensed retailers like Hearing Unlimited. Our online shop will open in mid-October, and we'll be offering a wide selection of OTC hearing aids from the top manufacturers.
If you're considering an OTC hearing aid, we encourage you to explore all your options and consult with a hearing healthcare professional to find the best solution for your needs. With the right device and a few adjustments, you may be surprised by how much more you can hear and effectively communicate.
Over-the-Counter vs Prescription Hearing Aid Devices
Now that we know what OTC hearing aids are and how they can benefit those with mild to moderate hearing loss, let's look at how they compare to their prescription counterparts.
As we mentioned before, OTC hearing aids are lower in cost than traditional hearing aids. This is in part because they also don't require a professional fitting or consultation, as well as important services like a hearing test in a test booth and verification to make sure the correct frequencies with your hearing loss are being amplified appropriately.
Another consideration is that traditional prescriptive hearing aids come with important post-purchase services in the basic maintenance of deep cleanings or repairs. This is different from an OTC and can be harder to get if bought off the shelf unless you go through Hearing Unlimited, where we have options to assist. Hearing Unlimited offers Telehealth (or remote support) for all traditional hearing aid purchases as well as for all OTC purchases through Hearing Unlimited.
Hearing aids sold over the counter offer some of the same features as their prescription counterparts. However, they don't have all the technology that some higher-end models provide. For example, OTC hearing aids may not have noise reduction or feedback cancellation features.
Finally, it's important to note that OTC hearing aids are intended to treat perceived mild to moderate hearing loss and aren't made for those with profound or severe hearing loss. If you have a more serious hearing impairment, you'll likely need to see a hearing healthcare professional for a prescription hearing aid.
How Do I Know I'm Getting Quality OTC Hearing Aids?
With the FDA's new regulations, all OTC hearing aids will have to go through a certification process to ensure they meet certain safety and quality standards. This (opens in a new tab) will help to ensure that all OTC hearing aids are effective and provide clear sound quality.
In addition, the FDA has created a new labeling system for OTC hearing aids, which will provide consumers with important information about the devices. This labeling system will include a QR code that consumers can scan to access online resources about the hearing aid, including how to use it and what to expect.
That said, buying hearing aids from just anywhere is never a good idea. At Hearing Unlimited, we'll only be selling OTC hearing aids from the top manufacturers in the industry. This ensures that our customers are getting high-quality devices that meet their needs. Our years of expertise as audiologists will also ensure that you get the best possible advice and guidance when choosing an OTC hearing aid.
How Do I Know If I Need a Hearing Aid?
Some of the most common symptoms of a mild to moderate hearing impairment include:
- Trouble hearing conversations, especially in noisy environments.
- Asking people to repeat themselves often.
- Turning up the TV or radio volume to levels that are uncomfortable for others.
- Struggling to hear on the phone.
This can also happen with a more severe loss, which is why a hearing test will be able to confirm what type of loss you have.
Do I Still Need a Hearing Exam If I'm Buying OTC?
If you're thinking about buying an OTC hearing aid, we do recommend that you schedule a with one of our audiologists at Hearing Unlimited. This will help to determine the severity of your hearing loss and whether or not an OTC device is right for you. However, by FDA guidelines for purchasing an OTC hearing aid, you do not need a hearing test if you choose not to and go by the perception of a mild to moderate hearing loss.
It's also important to get your ears checked regularly to make sure your hearing isn't deteriorating further. Our audiologists can help to monitor your hearing health and cognitive abilities.
Are You Ready to Try OTC Hearing Aids?
If you're ready to find out more about OTC hearing aids or schedule a hearing test, today. Our online hearing aid shop will be launching soon, and we'll have a wide selection of OTC hearing aids available for purchase. We can't wait to help you find the perfect device for your needs!
In the meantime, we'll be happy to answer any of your questions and help you find the best solution for you.