Based on a news release from the U.S. Food and Drug Administration dated Oct. 21, 2021, the agency is proposing a rule to establish a new category of over-the-counter (OTC) hearing aids. The proposed rule implements a key provision of the Over-the-Counter Hearing Aid Act, as enacted in the FDA Reauthorization Act of 2017.

When finalized, the rule would allow hearing aids within this category to be sold directly to consumers in stores or online without a medical exam or a fitting by an audiologist. 

What exactly does that mean to most consumers?

In the quest to make hearing aids more accessible and affordable, hearing aid options are about to get more complicated than ever before. Here’s why.

The OTC category would apply to certain air-conduction hearing aids intended for adults 18 and older who have perceived mild to moderate hearing loss. Hearing aids for severe hearing loss or for users younger than age 18 would still require prescription devices.

To ensure patient safety, the proposed rule also addresses a maximum output (volume) limit for OTC hearing aids that would prevent injuries from overamplification of sound.

In addition, the proposed rule includes certain device performance and design requirements, such as distortion control limits, self-generated noise limits, latency limits (how quickly an OTC hearing aid processes, amplifies and relays a sound), the range of frequencies that the device can reproduce and how uniformly the OTC hearing aid amplifies different frequencies over its bandwidth, as well as a requirement to limit the insertion depth of the device. The proposed rule also includes labeling requirements for OTC hearing aids.

What’s the catch?

While making hearing aids more affordable and accessible to all individuals with hearing loss is an honorable goal, this legislation doesn’t take into consideration the need for the consumer to first have their hearing evaluated by an audiologist or other medical professional to determine whether they even have a hearing loss, or the type and degree of hearing loss.

Skipping this important step in the assessment process means that an individual may think they have a mild to moderate hearing loss, leading them to purchase over-the-counter devices. In some cases, the consumer may not realize they actually have a more severe hearing loss that can’t be helped by OTC hearing aids, or they may not have a hearing loss at all. When that’s the case, the consumer could potentially waste hundreds of dollars on devices that won’t help them or aren’t appropriate.

To be sure consumers get the right technology for their hearing loss, professional organizations such as the Academy of Doctors of Audiology, the American Academy of Audiology and the American Speech-Language-Hearing Association recommend a comprehensive hearing examination before purchasing OTC or prescription hearing devices.

This not only ensures the patient receives an accurate diagnosis and recommendation for the type of hearing aids best suited to their individual loss, but that there aren’t any underlying medical conditions causing the hearing loss. These conditions can range from mild conditions like excess earwax build-up to very serious problems like tumors.

In addition, a consumer who purchases OTC hearing aids doesn’t have access to the expertise and advice an audiologist or medical professional can provide.

What can an audiologist do?

An audiologist has earned an Au.D. (Doctorate in Audiology), or a Ph.D. doctoral degree from an accredited university graduate program.

As part of their four-year doctoral training, audiologists spend a final year completing an externship experience supervised by a licensed audiologist. The externship provides practical, hands-on, advanced experience.

Following graduation from an accredited program, audiologists can diagnose, manage and treat hearing or balance problems for individuals from birth through adulthood including:

• Test hearing and balance. 
• Recommend, service, and adjust hearing aids.
• Recommend and provide assistive listening devices (products to enhance telephone conversations, television viewing, etc.). 
• Provide tinnitus assessment and management. 
• Provide education regarding the effects of noise on hearing and prevention of hearing loss. 
• Deliver counseling and aural rehabilitation (counseling, education, auditory training/exercises).
• Audiologists can make medical referrals to a physician when appropriate for issues such as ear pain, drainage from the ear, sudden hearing loss, cochlear implantation, etc.

Most importantly, audiologists are experts in diagnosing hearing loss, hearing aid technology, and prescribing the best technology for the patient’s individual circumstances. Audiologists also program these devices specifically for the patient and can check that the hearing aids are performing their best using real-ear technology. The consumer can’t do that.

What are OTC hearing aids?

When eventually available, OTC hearing aids will be an alternative to FDA-regulated prescription hearing aids, which are currently only available from hearing health professionals, such as audiologists, otolaryngologists (ear, nose, and throat doctors), and hearing aid specialists. Currently, the hearing health professional tests the consumer for hearing loss, and if the consumer has hearing loss, recommends and fits hearing aids, then adjusts the devices based on the specific hearing loss, and provides other services.

Under this new legislation, the consumer will be able to buy OTC hearing aids directly in stores and online, where today’s hearing aids are not available. The consumer will fit them and may be able to control and adjust the devices themselves.

Remember though, the consumer will be on their own with OTC hearing aids when it comes to fitting and adjusting the devices. And, OTC hearing aids will not be able to amplify sounds at high enough levels to help consumers with severe hearing loss.

The FDA is in the process of establishing regulations that manufacturers of OTC hearing aids will need to follow. In general, these federal regulations will:

• Ensure that the OTC devices are safe and effective for people with mild-to-moderate hearing loss.
• Set standards for package labels to help buyers understand OTC hearing aids and who might benefit from them. The labels will also include warnings and other information you should know before buying or when using the hearing aid, such as signs that indicate that you should see your primary care provider or other health care professional.

Can’t you already buy hearing aids over-the-counter?

Currently, hearing aids should not be purchased over-the-counter or online. The purchase of hearing devices requires a prescription from a medical professional, usually an audiologist.

However, you can purchase what’s known as personal sound amplification products (PSAPs) over-the-counter or online. These devices are not intended for people with hearing loss. These devices are for people with normal hearing. They’re intended to boost the user’s ability to hear certain sounds in certain situations, such as while hunting. While the FDA will regulate OTC hearing aids as medical devices for adults for hearing loss, PSAPs are not regulated as medical devices by the FDA.

To coincide with the proposed rule, the FDA also issued an updated draft guidance, Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products (PSAPs). The draft guidance describes hearing aids, PSAPs, their respective intended uses and regulatory requirements that apply to both types of products. The draft guidance is intended to provide further clarification regarding the differences between PSAPs, which help people with normal hearing amplify sounds, and hearing aids, and to inform consumers that PSAPs are not considered OTC alternatives for hearing aids.

Once these rules are finalized, consumers will have several categories of hearing devices to choose from:

• Prescription hearing devices—Prescribed based on a comprehensive hearing evaluation and fit by a medical professional (usually an audiologist). These devices are regulated by the FDA.
• OTC hearing devices—Available without testing to consumers who believe they have mild to moderate hearing loss. The consumer is responsible for self-diagnosis and fitting. These devices also are regulated by the FDA.
• PSAP hearing devices—These are NOT hearing aids. They are intended to help people without hearing loss boost the user’s ability to hear certain sounds. These devices are available over-the-counter and are not regulated by the FDA.

Which type of hearing device is right for you?

To learn more about the hearing options available to improve your hearing, schedule an appointment with a doctoral-level audiologist.