• Over-the-counter (OTC) hearing aids are a new category of hearing aids intended for adults with mild-to-moderate hearing loss. 
• You will be able to purchase OTC hearing aids without a required visit to a hearing health professional.
• OTC hearing aids are not yet available for purchase. Consumers are awaiting guidance from the FDA, which was expected in 2020 but delayed due to the COVID-19 pandemic.
• President Biden issued an executive order on July 9th, 2021 asking the FDA to produce guidance within 120 days.
• Direct-to-consumer hearing aids are for sale online, which may save you time and money. The expert guidance you receive from an audiologist will vary.

What exactly is an over-the-counter (OTC) hearing aid, and is it right for me? How are these different from the devices that are already available at the store? These are questions you may be asking yourself if you have hearing loss.

While there's been talk of upcoming changes to the way you can buy hearing aids for some time now, it still isn't clear to most buyers what over-the-counter hearing aids are, when and where to purchase them, and who may benefit from them. 

We'll help you answer these and other common questions you're likely to encounter as you search for the best hearing aid to meet your needs. 

Over-the-counter hearing aids are a new category of hearing aids that will allow adults with mild-to-moderate hearing loss to purchase a device without consulting a hearing professional. This option is not yet available but likely will be in the near future. 

In 2017 the federal government passed the Over-the-Counter Hearing Aid Act, which aimed to give consumers greater access to affordable hearing aids. Prior to this legislation, the FDA regulated hearing aids as Class I or II medical devices, which could only be obtained by prescription from a licensed professional. The idea that Americans should be able to purchase hearing aids over the counter is rooted in four primary issues, according to the American Academy of Audiology.

First, the high price of hearing aids prevents some people from seeking care when they need it. Second, many insurance plans do not cover hearing aids. (While hearing care may be covered by some Medicare Advantage plans, Original Medicare excludes this benefit.) Third, access to hearing care professionals may be limited in certain areas of the country. Finally, consumers are demanding greater control over their health care, and the ability to manage their own hearing loss could save them time and money. 

The 2017 federal law requires OTC hearing aids to use the same scientific technology as existing hearing aids. However, OTC devices must allow the wearer to control and customize the device. This is in contrast to prescription hearing aids that typically require a visit to an audiologist or hearing center each time an adjustment must be made to a device. Keep in mind, though, that an audiologist is able to program hearing aids to your specific hearing needs (sometimes including extensive changes to improve how your hearing aid works for you), and you won't get this customization when you bypass their services.

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When lawmakers passed the legislation in 2017, they tasked the FDA with the development of regulations for the new category of OTC hearing aids, which was supposed to be complete no later than August 2020. The FDA, however, failed to meet this deadline due to the ongoing COVID-19 pandemic. To date, the FDA has given no further guidance on the issue or a timeline to determine when guidance can be expected. Plain and simple, this means the category of OTC hearing aids doesn't truly exist yet since the FDA hasn't produced the required regulations. Therefore, OTC hearing aids are not currently available.

However, on July 9th, 2021, President Biden issued an executive order asking the U.S. Department of Health and Human Services, which includes the FDA, to issue this guidance within 120 days.

Once the FDA issues its ruling and the proposed timeline, consumers should soon be able to purchase OTC hearing aids at their local pharmacy without visiting a medical provider. While the specifics are still unknown, the goal of this initiative is to lower prices for consumers, so more affordable hearing aid alternatives should make their way to consumers in the near future.

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Personal sound amplification products, known as PSAPs or hearing amplifiers, are devices that amplify sound in certain environments or situations where someone with normal hearing may need help hearing, such as in bird watching. While PSAPs are sold in many stores, they are not intended to be used as hearing aids for those with hearing loss.

While some in-ear amplifiers may look similar to a hearing aid, they do not employ the same technology and are not regulated as such. Amplifiers make all sounds louder. Hearing aids improve the quality of sound through a complex and individualized manipulation of sound that is specific to a person's type and degree of hearing loss.

No. Along with hearing aids provided by a hearing health care provider and over-the-counter hearing aids, there is another category often described as direct-to-consumer devices. Some companies are now offer hearing products directly to you online, potentially making it easier and more convenient to purchase a hearing aid. Companies such as Lively, Eargo, Audicus, and MDHearingAid offer top-quality products and deliver them straight to your door at a fraction of the cost of hearing aids from a hearing center.

Many of these direct-to-consumer companies offer an online hearing test or allow you to use the results of an in-person hearing test previously conducted by an audiologist. You may purchase the product online, have the product shipped directly to your home, and receive training and support in its use through a virtual or phone consultation. While the service varies from company to company, some direct-to-consumer brands provide consultation with an audiologist and custom programming of your device—services you'd only expect to get from an in-person hearing center. Online hearing aids are often significantly less expensive than those purchased from an audiologist, but they may not include the services that come along with a purchase from an in-person hearing health care provider.

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Many audiologists question whether consumers will be able to get the hearing care they need from an over-the-counter device without an audiologist to guide them. Health consulted with Lindsey Jorgensen, AuD, PhD, professor at the University of South Dakota and board member of the American Academy of Audiology. She offered her perspective on the value of an audiologist consultation when purchasing a hearing aid. 

"Although choosing a hearing aid may seem like an easy decision, there are many steps and considerations that go into finding the right device that meets your needs and expectations. Hearing loss is not a simple fix, and without a strong knowledge of what a hearing aid can and cannot do, you may not be choosing the right one for you." 

The vast array of choices in both models and specifications of hearing aids can become overwhelming, and you're likely to have plenty of questions. 

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"Visiting an audiologist may help narrow those choices to a device that is within your price range," says Jorgensen. "Together you and your hearing health care provider will take into account what is best for your needs by assessing your audiogram, physical limitations, communication needs, and personal preferences, all of which will help determine the device you choose. Choosing this device together will ensure that you are more satisfied and, therefore, get the most out of your hearing aid."

Many direct-to-consumer companies offer an audiologist consultation via phone or virtually to interpret your hearing test and guide you in your purchase. A few companies even offer ongoing support for several years or the life of the product. If you decide to purchase a hearing aid online, be sure you know what type of support the company offers, as this is one of the greatest differentiators among companies that sell hearing aids online. In the near future, you may even be able to get a quality OTC hearing aid and skip the audiologist consult completely. 

Dr. Courtney Schmidt is a clinical consultant pharmacist and geriatric care expert. Since completing her Pharm.D. at the University of Florida, Dr. Schmidt has worked in multiple clinical settings and has served as an Adjunct Professor at the University of Central Florida. 

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