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What Are Over-the-Counter Hearing Aids, and Will They Change the Game?

A guide to over-the-counter hearing aids

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Audiologist examining ear

If you have difficulty hearing, you're not alone. Hearing loss is a serious and complex medical condition that affects roughly 48 million Americans.1 The Food and Drug Administration's (FDA) final rule establishing a new category of over-the-counter (OTC) hearing aids is undoubtedly getting a lot of press, but will these self-fit devices fully meet the needs of people with hearing loss?

In this article, we'll discuss the best candidates for OTC hearing aids and how they differ from traditional medical-grade devices. FDA regulations can be confusing, so we'll dive into the FDA's definition of OTC hearing aids and how this regulation may affect individuals with hearing loss. Read on to find out if OTC hearing aids will fit your hearing health, lifestyle, and budget needs.

What Are Over-the-Counter Hearing Aids?

A recent study found that more than one in four seniors forego hearing aids because of cost. To expand consumer access to hearing aids and improve affordability, the FDA has established a new category of OTC hearing aids. Consumers can buy OTC hearing aids in the store or online without seeing a physician for an exam or an audiologist for help with a fitting.2

Traditional hearing aids purchased in-office can come with a hefty price tag; some brands charge up to $4,000 per device. Historically, you needed to go to an audiologist, ENT, or hearing aid specialist to be professionally diagnosed and fitted. Since Original Medicare does not cover hearing aids, older adults are often caught off guard by these unexpected out-of-pocket expenses. OTC hearing aids may help alleviate these hurdles.

Has the FDA Approved Over-the-Counter Hearing Aids?

Yes. On Aug. 16, 2022, the FDA finalized the new OTC hearing aid category, its intended users, and the conditions for OTC hearing aid sales. OTC hearing aid legislation has been years in the making. Under the FDA Reauthorization Act of 2017, the

FDA was tasked with updating regulatory guidelines for hearing aids and personal sound-amplification products.3 This historic August 2022 ruling is the final result. Effective Oct. 17, 2022, individuals with mild to moderate hearing loss can purchase FDA-approved hearing aids in stores or online without the need for a medical exam, prescription, or audiologist visit.4

Who Are OTC Hearing Aids Best For?

According to the National Institute on Deafness and Other Communication Disorders (NIDCD), OTC hearing aids are for adults who believe they have mild to moderate hearing loss, even if they have not had a hearing exam. The NIDCD says you may have mild to moderate hearing loss if:5

  • Speech or other sounds seem muffled.
  • You have trouble hearing when you're in a group, in a noisy area, on the phone, or when you can't see who is talking.
  • You have to ask others to speak more slowly or clearly, talk louder, or repeat what they said.
  • You turn up the volume higher than other people prefer when watching TV or listening to the radio or music.

Keep in mind that OTC hearing aids aren't for everyone. They're not meant for children or people with severe or profound hearing loss. OTC hearing aids are also not viable for adults with medical problems such as an ear deformity, ear injury, vertigo, or sudden hearing loss. If you suffer from a hearing-related condition, have a doctor address these symptoms before purchasing a hearing aid.

FYI: There's no need to worry if you're not a candidate for OTC hearing aids. You still have plenty of options! For a list of top-notch online and medical-grade hearing aids, head over to the best hearing aids for seniors.

How Are Over-the-Counter Hearing Aids Different From Traditional Hearing Aids?

Buying hearing aids over the counter

No two hearing aids are created equally. It's essential to understand the different types of hearing aids, who they are best for, and how to buy them. Use the information below to help determine if OTC hearing aids will fit your hearing health needs. We'll also cover the advanced technical features OTC hearing aids may be missing.

Over-the-Counter Hearing Aids

The category of OTC hearing aids puts the wearer completely in the driver's seat. OTC hearing aids are sold directly to the consumer and can be purchased without a hearing exam. That means there won't be any professional care or fitting, so you'll be responsible for determining your hearing needs. The sale of OTC hearing aids will likely be comparable to reading glasses that are purchased over the counter. These devices may work for individuals with mild or moderate hearing loss who require only a sound boost in certain settings.

FYI: Visit our hearing aid buyer's guide for an in-depth look at hearing aid providers, types of hearing aids, and ways to save money on your purchase.

Online Hearing Aids

Individuals with mild to moderate hearing loss can take advantage of direct-to-consumer FDA-approved hearing aids. Several brands, such as MDHearingAid, Lively, and Eargo, sell hearing aids online without the need for an in-person visit to an audiologist. These online brands are a one-stop shop, allowing you to take a hearing test and explore your hearing aid options from the comfort of your home. Online hearing aid pricing tends to be lower than hearing aids that must be purchased in person. Benefits aren't lacking, and many online brands include telehealth consultations with an audiologist, 24/7 customer support, and high-end features such as Bluetooth hearing aid capability. Hearing aids purchased online, however, will be suitable only for mild to moderate hearing loss.

Medical-Grade Hearing Aids Purchased In Person

Purchasing hearing aids from an audiologist is a full-service experience. Your audiologist works with you every step of the way in your hearing health journey. Face-to-face, personalized assistance is as simple as heading to your doctor's office. From administering an in-depth hearing test and checking for ear trauma or deformity to helping you customize the best aid for your hearing loss, your audiologist offers in-person care and training during this complex process. Medical-grade hearing aids are best for individuals with mild to profound hearing loss. Well-known hearing aid brands include ReSound (with nearly 80 years in business) and U.S.-based retailer Starkey. These hearing aids are more expensive than online options, but the service and care is customized to your individual needs, making it worth the cost in our book.

Can You Buy Hearing Aids Over the Counter?

Person buying hearing aids over the counter

FDA-approved OTC hearing aids hit the market Oct. 17, 2022. You can purchase OTC hearing aids in stores and online at locations including Amazon, Best Buy, Walmart, CVS, and Walgreens. Head over to our best over-the-counter hearing aids review for a list of top-ranking OTC and online hearing aids.

Many of these retailers also carry personal sound-amplification products (PSAPs). PSAPs are not OTC hearing aids and have not been regulated by the FDA, which considers PSAPs wearable electronic products for people who are not hearing impaired, as opposed to medical devices.6 PSAPs enhance some sounds for specific situations, but they're not medically approved for hearing loss. Check the packaging carefully as you shop, since OTC hearing aids will be clearly labeled by the FDA.

In anticipation of the FDA's finalized regulation, the consumer electronics industry has thrown its hat into the OTC ring. In 2019, Apple added features to its AirPod Pro that allow users to customize their audio experience to suit individual hearing needs. Features include Conversation Boost and Live Listen with noise cancellation.

For a closer look at the ins and outs of OTC hearing aids, watch our video with SeniorLiving.org editor-in-chief Jeff Hoyt and Dr. Ruth Reisman, AuD.

How Much Do Over-the-Counter Hearing Aids Cost?

In an August 2022 statement issued by President Joe Biden, it was noted that the final FDA ruling would deliver nearly $3,000 in savings to American families for a pair of hearing aids.7 The U.S. government continues its work to expand access to high-quality health care and lower medical care costs, including that of hearing aid technology.

All OTC pricing has not been released, but we anticipate competitive price points as OTC hearing aids are launched to consumers and the market expands. At the time of this article, a handful of retailers have announced pricing, including Walmart, Walgreens, and Sony. Walmart's OTC hearing aids start at $200, Walgreens will sell the Lexie Lumen OTC hearing aid for $799, and Sony will offer self-fitting OTC hearing aids starting at $999.

We're certainly interested in where OTC hearing aid pricing will land compared to the affordable hearing aids currently available for purchase. For a list of wallet-friendly hearing aids that won't bust your budget, head over to our article on the best cheap hearing aids for seniors.

In the video below, Jeff Hoyt, SeniorLiving.org's editor-in-chief, speaks with audiologist Brad Ingrao about how OTC hearing aids could help millions of Americans with mild to moderate hearing loss.

Consider Your Overall Hearing Goals

Hearing health plays a key role in your quality of life. As reported in the New England Journal of Medicine, untreated hearing loss in adults can lead to higher rates of social isolation, depression, and dementia.8 Before purchasing OTC, online, or medical-grade hearing aids, it's important to consider what you want your hearing aids to achieve. Will the hearing aid be solely for amplification purposes, or will it provide advanced assistance through features such as artificial intelligence, fall detection, and tinnitus management?

If one of your hearing goals is improving hearing and communication, then explore the wide range of advanced hearing aid features. Research has repeatedly shown that the brain will adapt and rewire itself to the most consistent input it is being given. We want to activate those appropriate hearing structures designed to respond to specific speech stimuli. That will ensure that auditory pathways will be strengthened, providing the best chance for success in maintaining a healthy, functional central auditory system.

An example of this would be a patient that has to go for occupational therapy after shattering their hand. During treatment, they decide to rehabilitate all their fingers except their thumb. How functional will their hand be in the long term?

Will Over-the-Counter Hearing Aids Lack Advanced Features?

OTC hearing aids are not required to offer the advanced features included with medical-grade hearing aids. Based on the new FDA ruling, all OTC hearing aids must have a user-adjustable volume control, but consumers will probably have limited flexibility for individual customization and adjustments. OTC hearing aids will likely represent the original type of hearing aids that amplify everything equally.

As you explore OTC hearing aid options, closely read the product specifications found on the packaging. The FDA requires the following features to be disclosed on the labels of all FDA-approved OTC hearing aids.

  • If a smart device is required. Some OTC hearing aids rely on wireless technology like a smartphone, a remote sold separately, or a personal computer to program and adjust the hearing aid.
  • If the battery is replaceable or rechargeable. Labeling will indicate battery requirements, such as how many batteries are needed and if they are included.
  • If the hearing aid has Bluetooth or telecoil compatibility. The packaging will disclose how the hearing aid connects to the control platform, such as via Bluetooth or a USB cable.

Quick Tip: Confirm the OTC hearing aid return policy, since it is left up to the manufacturer or retailer, not set by the FDA.

There is a lot of research and development that goes into building a hearing aid that can mimic the complex hearing system. Hearing aids will never repair inherent nerve damage, so we are always working with an impaired system. Getting the cleanest unadulterated signal to the brain through a damaged system can be like driving a four-wheel sedan through the mud. It's possible the car will get from one side to the other, but wouldn't it have been easier to get there with a vehicle that is actually designed to do that?

Below we'll take a look at a variety of advanced features available with medical-grade hearing aids, how they ensure long-term success, and factors to consider as you weigh the pros and cons of OTC hearing aids vs. medical-grade aids.

Medical-grade hearing aid features Advanced benefits
Frequency response range The larger the frequency range a hearing aid can boost, the more precise the speech signal provided. Speech is a complex signal with at least three frequency response layers whose energy spans an extensive range of pitches. That is one significant differentiator between technologies. The wider the frequency response, the better the user will perform. If you look closely at the device specifications, you can often see the frequency range for the device.
Advanced front-end features Since individuals with hearing loss have impaired neural responses, the hearing mechanism lacks response accuracy. That can be compared to vision loss. Impaired vision sends a blurred image to the brain. Hearing aids with advanced features such as adaptive directionality, noise reduction, feedback management, and speech enhancement will clarify the speech signal on the front end, sending the clearest signal to be processed by the brain.
Compression Individuals with hearing loss have reduced dynamic ranges. The difference is smaller between when a sound is first heard and when sounds begin processing too loud. In order to input a wide range of signals with varying intensities, the hearing aid needs to be able to compress the large range of inputs into a small dynamic range. It needs to be able to accurately represent soft, medium, and loud sounds.
Binaural integration When wearing two hearing aids, it's important that they work together to improve speech understanding and localization. We have two ears because we hear better with two ears, especially in challenging environments. That's why the hearing devices must work together to better restore normal hearing.
Feedback and occlusion management Two common complaints of people wearing hearing aids are feedback or whistling and occlusion, affecting the perception of the patient's voice. Advanced hearing aids will have the mechanics to adjust for these concerns.
Earpiece customization Almost all hearing aids come with a selection of generic ear tips. Choosing the correct earpiece for the patient’s hearing loss is crucial to their ability to maximize hearing aid benefits. Often, patients choose the wrong size earpiece, causing critical sounds and hearing aid processing effects to be lost.
Frequency channels and gain handles The higher the level of technology, the more frequency channels and gain bands the hearing aid will have to customize to an individual's hearing loss. That can be compared to pixels in an image. The more pixels an image has, the clearer and brighter it is. That is true with hearing aids as well. The more channels and bands a device has, the cleaner and clearer the speech signal is being sent to the central auditory pathways.

Hearing aids are an investment. Before making a big purchase, watch the video below to find out if you're eligible for free or discounted hearing aids.

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Written By

Dr. Ruth Reisman

Audiologist

Ruth Reisman, AuD MBA, is a licensed audiologist and hearing aid dispenser in New York state and is certified by the American Speech and Hearing Association. After serving as an audiologist in the New York downstate hospital system, Dr. Reisman led the… Learn More About Dr. Ruth Reisman

Citations
  1. American Speech-Language-Hearing Association. (2021). New Poll of U.S. Adults Reveals Widespread Inaction on Hearing Loss.

  2. U.S. Food and Drug Administration. (2021). Hearing Aids and Personal Sound Amplification Products: What to Know.

  3. U.S. Government. (2017). PUBLIC LAW 115–52.

  4. U.S. Food and Drug Administration. (2021). Hearing Aids.

  5. National Institute on Deafness and Other Communication Disorders. (2021). Over-the-Counter Hearing Aids.

  6. U.S. Food and Drug Administration. (2016). The FDA engages stakeholders on opportunities to improve hearing aid usage and innovation.

  7. U.S. Government. (2022). Statement by President Joe Biden on FDA Hearing Aids Final Rule.

  8. National Library of Medicine. (2017). Hearing Loss in Adults.