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Articles | Hearing Aids

Over-the-Counter Hearing Aids: What You Need to Know

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In August 2017, a law was passed that allows FDA-regulated hearing aids to be sold over the counter instead of by a trained hearing healthcare professional. It’s estimated that Over-the-Counter (OTC) hearing aids will not be available to consumers for a couple years; however, it’s important to talk about the topic now, as it can have a big impact on how society views treatment for hearing loss in the United States.

Introducing a new category of hearing aids will have a few different implications. There will be a difference in cost, but also in the devices themselves, and the quality of care the user receives. Whether you are looking to treat your own hearing loss, or are interested in helping a family member, here’s what you should know about OTC hearing aids.

OTC Hearing Aids are Different from PSAPs

First, we must distinguish between OTC hearing aids, and products that are currently on the market. You may also be familiar with the term PSAP, or Personal Sound Amplification Product. PSAPs are different from OTC hearing aids. PSAPs are not regulated by the FDA, and they cannot be marketed to consumers as devices that improve impaired hearing. These products simply claim to amplify sound, not compensate for hearing loss. On the other hand, OTC hearing aids will be marketed as devices that can treat individuals with mild to moderate hearing loss.

These devices are the same in that you do not necessarily need to go to a hearing healthcare professional to receive one.

It is Important to See a Hearing Healthcare Professional

Hearing healthcare professionals provide so much more than hearing aids. They offer comprehensive hearing care, can fit a hearing device to your specific needs, and will provide follow-up care and adjustments after you’ve been fitted.

Hearing aid technology is constantly evolving. Many hearing healthcare professionals attend workshops and trainings to continue their education and learn more about the latest hearing devices. If you try hearing aids and find they are not performing well for you, your provider will be able to make the adjustments you need. Typically, your provider can give you a trial period where you can evaluate the devices, risk-free.

There are also your medical needs to consider. Sometimes hearing difficulties are related to—or caused by—other medical conditions ranging from an earwax blockage to a brain tumor. In fact, there are a number of conditions related to hearing loss such as heart disease, diabetes, sleep apnea, and more. If the hearing difficulties are caused by something such as a perforated eardrum or a wax impaction, sticking something in the ear canal could actually worsen the problem and be potentially dangerous.

When you buy hearing devices over the counter, you are bypassing a trained professional who would be able to identify possible causes of your hearing loss or refer you to a specialist who could.

This is not a new concern. More than one third of the U.S. population use the internet to self-diagnose a medical condition. While the internet can be a great resource for self-education, it can be harmful when used in the place of a trained professional. One concern with OTC is that individuals are not trained to know the correct settings for their hearing devices. If they set the volume too high, it could potentially damage their residual hearing.

Organizations in the hearing healthcare industry are making recommendations for these devices with the goal of reducing the potential harm that can come with self-diagnosis. Moderate to severe hearing loss often comes with more medical complications than mild hearing loss. It is the recommendation of Hearing Industries Association (HIA) that OTC hearing aids should be offered only to people with mild hearing loss. HIA is also urging the FDA to set high standards for these devices, in hopes that they will be safe and effective.

Before determining that you have a hearing loss and/or making a decision to purchase a hearing device, make an appointment with a hearing healthcare professional first. You could be surprised by what you learn!

There is a Difference in Cost and Value

Some proponents of OTC hearing aids claim the devices will offer a lower cost option for those who don’t want to invest in a hearing aid. So, why do hearing aids cost so much?

Today’s hearing aids are drastically different than those of the past. Hearing aids are full of sophisticated technology that has to be scaled down to fit comfortably behind and/or inside your ear. Because of this, there is a lot of research and development that goes into the making of a hearing aid. These tiny devices not only quickly process information and adapt to different sound environments, many of them have features such as tinnitus therapy, feedback cancellation, internet streaming capabilities and more. In addition to all these features, they must be made to withstand sweat, earwax, and other elements.

If you have ever experienced hearing loss, you know that it takes a lot of mental energy to strain to hear and understand better. It can be exhausting! Hearing aid manufacturers are constantly working to develop products that can provide an easier and natural listening experience. The research that goes into these incredible devices is one reason why the cost may be high.

You must also consider the value of the services you are receiving. Adjusting to hearing aids takes time, and when you buy an OTC hearing aid, you are missing out on the assurance that a trained professional will be there to help you through the process every step of the way. Most hearing aids come with a manufacturer warranty to cover maintenance and common issues that arise with hearing aids. Protection such as the Secure 4-Year Warranty lasts four full years and covers service, repairs, cleanings, and adjustments. This is crucial due to the general wear and tear hearing aids go through.

What We Can Expect from OTC Hearing Aids

Because this law concerning OTC devices was just passed in August 2017, it’s too early to determine what the OTC model will look like. The FDA is still in the process of creating guidelines for these devices that manufacturers will have to comply with. Then, it will take some time for the device to come to market. It will likely be a couple years before we get a clear picture of what these devices will look like.

Will OTC Help More People?

Currently, only 20 percent of Americans who could benefit from hearing devices use them. Many supporters of OTC believe that this new option will close this gap. However, it’s important to recognize that cost is not the only barrier. We can see this by looking at countries where hearing aids are free—or at least heavily subsidized. For example, in Switzerland and the UK, the rates of hearing aid adoption are 38 and 41 percent respectively.

Ideally, OTC hearing aids will help reduce the social stigmas associated with hearing loss and hearing aids. Traditionally, hearing aids have been seen as something meant for older individuals, but hearing loss advocates are working to change that. Truthfully, hearing loss affects people of all ages. In fact, 20 percent of people in their 20’s have some degree of hearing loss. Some manufacturers have a vision that everyone will be wearing some sort of earbuds or “hearables” in the near future, regardless of their hearing ability.

The bottom line is that if you think you need a hearing device, the best thing you can do is make an appointment with a hearing healthcare professional. They will be able to help you and give you the best recommendation for your needs.


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Put Your Hearing to the Test

Sometimes, hearing loss happens so gradually that it can be difficult to notice at first. However, there are some common signs that indicate you may have hearing loss. Want some answers now? Take this short survey to determine if it's time for you to make a hearing appointment.

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Read the following statements and select “yes” if they apply to you most of the time, “sometimes” if they apply once in a while, and “no” if they don't apply at all.

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