In 2017, Congress passed the Over-the-Counter Hearing Aid Act to make it easier for consumers to purchase affordable hearing aids. And on October 17, 2022, the FDA finalized its ruling that now allows companies to sell OTC hearing aids without a medical exam, prescription, or professional fitting. OTC hearing aids are still regulated as medical devices by the FDA. Before this legislation, consumers had to obtain a prescription from a licensed professional in order to purchase hearing aids. According to the American Academy of Audiology, four primary issues emphasize the need for Americans to have the ability to buy hearing aids over the counter:

  1. Some people are unable to afford the cost of hearing aids.
  2. Many insurance plans, including Medicare, do not cover hearing aids. a. Note that many Medicare Advantage programs do offer some hearing aid benefits.
  3. Some geographic locations have limited access to hearing care professionals.
  4. Consumers want to save time and money and have more control over their purchasing decisions. The new FDA regulations governing OTC hearing aids ensure that OTC hearing aids will be safe and effective. In addition to specifying maximum volume levels, insertion depth, and labeling requirements, the regulations describe the requirements for buying hearing aids without a prescription via mail, in-person, or online. OTC hearing aids use the same scientific technology as existing hearing aids while offering users more purchasing options and the ability to customize the device. They’re different from prescription hearing aids, however, which may require a visit to an audiologist or hearing center every time you need an adjustment. Some prescription and OTC hearing aids offer remote adjustments, which is a convenient option for many people. That said, a visit to an audiologist or hearing professional can be beneficial for certain people, because those experts can diagnose underlying medical conditions that may be causing your hearing loss. The American Speech-Language-Hearing Association recommends seeing an audiologist for a hearing test before buying hearing aids, since audiologists can rule out causes of hearing loss not treated by hearing aids, such as too much wax in your ears.

Do I Need to Visit an Audiologist or Hearing Center to Buy Hearing Aids?

To purchase prescription hearing aids, you need to work with an audiologist or hearing instrument specialist. From October 17, 2022, you can now purchase OTC hearing aids from companies that do not require an audiologist or hearing center visit. The National Institute on Deafness and Other Communication Disorders states that this new category of hearing aids is intended for adults over the age of 18 who have mild to moderate hearing loss. OTC hearing aid companies, such as Eargo, Jabra Enhance (formerly known as Lively), and Audicus, offer hearing aids that typically cost less than traditional prescription hearing aids like those from ReSound and Oticon. And with the new rules now in effect, you can also purchase hearing aids from retailers such as Best Buy, Walgreens, and Walmart.

Lower Costs

Our reviews team collected survey responses from 600-plus hearing aid users, and more than 17 percent of those respondents reported that price was the most important factor when making a hearing aid purchase (making it the second most important feature in a hearing aid, behind only “easy to set up and use”). With OTC hearing aids, you can typically purchase devices that cost less than similar options from prescription brands. For example, Oticon hearing aids typically range from $1,099 and $3,500 per device, while OTC Audicus hearing aids range from $499 to $1,399 per device. OTC hearing aids will add even more cost-effective alternatives to the market.

Convenience and Ease

Several OTC companies offer an online hearing test or the ability to use the results of a previous in-person hearing test performed by an audiologist. Online ordering also makes it more convenient and easier to buy hearing aids, since customers no longer have to go through a hearing center or doctor’s office. These products can be shipped to you directly, and most brands provide support and training through a virtual consultation (or over the phone). It’s important to note that the services offered by OTC companies can vary in terms of quality and access. Although online hearing aids can be significantly less expensive than traditional ones, they may not include the same benefits that you’d get from an in-person hearing care provider. Also, OTC hearing aid brands are not a good choice for those with severe or profound hearing loss. PSAPs are not intended to improve hearing in everyday situations or to help those with hearing loss — but OTC hearing aids are designed specifically for that purpose. In other words, amplifiers increase the volume of sound, while hearing aids improve the quality and volume of sound based on a person’s specific type and degree of hearing loss. But it took a while to get here. In 2017, when lawmakers passed the Over-the-Counter Hearing Aid Act, they tasked the FDA with developing regulations for OTC hearing aids by August 2020. Due to the COVID-19 pandemic, the FDA failed to meet this deadline. On July 9, 2021, President Biden issued an executive order asking the U.S. Department of Health and Human Services, which includes the FDA, to issue guidance within 120 days. It wasn’t until August 16, 2022, that the FDA issued a final rule, and October 17, 2022 that the rule went into effect. According to Trisha Muth, AuD, doctor of audiology at Bay Area Audiology in Bel Air, Maryland, OTC hearing aids “can be a good stepping-stone before obtaining prescription hearing aids for those with mild to moderate hearing loss.” While they may not offer some of the more advanced features that treat severe or profound hearing loss, OTC hearing aids will be easier to obtain and much less expensive. You can purchase hearing aids online, through a professional hearing specialist — and now you can buy them over the counter as well. Visiting an audiologist or hearing care professional in person can be a good place to start for any type of hearing loss. Many online hearing aid brands also offer online hearing tests and virtual consultations with an audiologist to help you make an informed decision about your purchase.