This change is expected to expand your access to high-quality hearing care, while at the same time spurring innovation that could save an average of between $2,800 and $3,000 on the cost of a pair of hearing aids.
What Are the New FDA Regulations for Hearing Aids?
The FDA regulation changes have created a new category of hearing aids that can be sold without the need for a medical examination, and thus are expected to result in significant savings for consumers on the cost of quality hearing aids. The new category does not replace prescription hearing aids for people with severe hearing loss—they will still be available and will still require a medical exam. The new OTC devices target a much larger group of people with mild-to-moderate hearing loss.
This new rule is not really “new”. It was first proposed as part of the FDA Reauthorization Act of 2017. In the time since then, the FDA has reviewed thousands of comments by audiologists, manufacturers, and the general public, with the goal of providing access to quality hearing aids at a reasonable cost while ensuring they are still safe and effective.
The “reasonable cost” goal is important, because the current cost of prescription hearing aids (plus the medical examinations and services required to get them) ranges from a low of $2,000 per pair to highs of over $7,000. These costs are not covered by Medicare or most private health insurance policies. The result has been that only one in five Americans who need hearing aids have been able to afford them. In fact, one recent study found that Americans aged 50 to 80 were twice as likely to take their pet to the veterinarian than they were to get their hearing checked.
The final FDA ruling was achieved as part of President Biden’s Executive Order on Promoting Competition in the American Economy, which allows the sale of this new category of OTC hearing aids by mid-October.
Along the way, the FDA has expanded upon its original rule to include changes such as lowering the maximum sound output of the devices to prevent further hearing damage, requiring that the hearing aids have user-adjustable volume controls, and requiring simplified, easy-to-understand language on the product labels.
What Types of Hearing Aids Will Be Available Without a Prescription?
Most hearing aids work through air conduction, by amplifying the sound before it reaches your ear canal. Less common types work via bone conduction. Hearing aids can take many forms, including behind-the-ear and in-the-ear models. You can read an overview of these different types in our article on the best hearing aids of 2024.
The new category of hearing aids that can be sold OTC includes certain air-conduction hearing aids intended for adults (over the age of 18) who have perceived mild-to-moderate hearing impairment. They are not intended for children or for use by those with severe hearing impairment.
Here are a few typical symptoms of mild-to-moderate hearing loss.
You struggle to hear conversations in crowded, noisy areas
You find yourself consistently turning up the volume on your television or computer
You have a hard time distinguishing between voices when many people are speaking at once
You feel as if you are “missing words” in conversations
You frequently need to ask people to repeat themselves
If you have similar symptoms, OTC hearing aids may be a solution for you. However, people with severe hearing loss will still need to get prescriptions for hearing aids from professionals such as ear, nose, and throat doctors and audiologists.
OTC hearing aids are likely to be available in both in-ear and behind-the-ear forms, and you will be able to choose and fit them yourself or with the help of your pharmacist. The specific styles and forms these hearing aids take will depend on the manufacturer and market, but some might connect with a smartphone for configuration and even be able to transmit calls, and some might use rechargeable batteries while others will not.
The new FDA ruling notes the possibility of “preset” parameters in some hearing aids, while others will be fully customizable, otherwise known as “self-fitting”. The ruling also requires that these products include package labels which explain OTC hearing aids and provide warnings about when to see a doctor instead of trying to buy an OTC hearing aid yourself.
What Does the New FDA Rule on Hearing Aids Mean for You?
If you need hearing aids but have been putting them off because of the high cost, the most obvious benefit to you is going to be the price. These OTC devices go on sale in October 2022. Manufacturers will set their own prices, but the cost is anticipated to be $200 to $300 per device.
This is a huge cost reduction compared to currently available prescription hearing aids. With such a big price drop, millions of people who need hearing aids should finally be able to afford them. According to the American Academy of Audiology, under the current prescription system, people wait an average of 7 to 10 years to seek help after they first experience symptoms of hearing loss. That is too long, because untreated hearing loss gets worse, not better.
Hearing loss has been shown to negatively impact daily communication, impede social interaction, and reduce individuals’ quality of life. The American Academy of Audiology also claims that untreated hearing loss is associated with an increased risk of isolation, depression, falls, and cognitive decline. So, having more timely and less expensive access to hearing aids may potentially reduce your risk of Alzheimer’s and help to improve your overall health.
One thing to note about the new OTC hearing aids is that you will choose them yourself, fit them yourself, and adjust them yourself to suit your particular degree of hearing loss. This does place more responsibility on you, the consumer. But it also provides some benefits, because the new OTC devices often allow you control over features that prescription hearing aids would require you to see a professional to adjust, such as noise reduction and relief from tinnitus.
Where Will I Be Able to Buy OTC Hearing Aids?
Over-the-counter hearing aids will be available from small retailers, from “big box stores” like Walmart or Costco, online, and from local pharmacies. Pharmacies may become the best places to get OTC hearing aids because they are more accessible to most Americans. Audiology practices, after all, tend to be located only in metropolitan areas, whereas 90% of Americans live within five miles of one of the more than 61,000 local pharmacies in the U.S.
Community pharmacists are already trained to identify, prevent, and help to resolve numerous health problems. New training courses are already being designed to help them fit and maintain this new category of OTC hearing aids.
Features of OTC Hearing Aids
Naturally, each manufacturer of OTC hearing aids will determine the built-in and optional features of their devices, but here are a few that might be of interest to you when you’re shopping around:
Directional microphones can help you hear sounds in noisy environments.
Noise reduction can filter out background noise to aid hearing.
Smartphone connectivity can allow you to stream calls to your hearing aids.
Telecoil capability can allow hearing aids to pick up sound from compatible phones or sound systems in places like theaters or churches.
Wireless connectivity such as Bluetooth can allow the hearing aids to interact with TVs, computers, tablets, and cellphones.
Questions to Ask Before Buying OTC Hearing Aids
Is there a free trial period, or a money-back return policy? Is there a warranty?
Will you be able to set up the hearing aids yourself? Are there manuals or videos to show you how to do it?
Do you need a computer or smartphone to install and customize them?
How do you adjust the volume? Will you be able to do it easily?
Are the hearing aids water- and sweat-resistant?
Are the batteries rechargeable? If not, how long do they last and what do they cost to replace?
Do they have connectivity to smartphones via Bluetooth or Telecoil?
If you are buying from a pharmacy, has the pharmacist received training on how to help you choose, set up, and maintain OTC hearing aids?
Does the manufacturer have a customer support phone number? (Legally, they are not required to, but it’s better if they do.)
Conclusion
Although there will certainly be some confusion in the beginning as hearing aids become available over the counter, it is clear that this FDA rule is a huge step forward in hearing care for Americans. The prescription-based system was problematic, largely because the cost of required exams and services more than doubles the cost of the hearing aids themselves.
So, if you or an adult loved one with mild-to-moderate hearing loss has resisted getting a hearing aid due to the cost or the hassle of finding a qualified health professional to prescribe one, this new FDA ruling is great news. As soon as October 2022, you will be able to visit your online or in-person pharmacy to explore, try out, and choose an in-ear or behind-the-ear hearing aid yourself. Given the potential range of hearing aid styles that will be available as this new initiative is launched, we recommend an in-person chat with your pharmacist about the features and results you’d like before buying one for the first time.
