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Hearing Aids and OTC Laws: How Have They Changed?
By Georgia Carter MONEY RESEARCH COLLECTIVE
In 2017, the government passed the Over-the-Counter Hearing Aid Act to make it easier for consumers to access these vital devices without needing a prescription from an audiologist or physician. This law created unprecedented changes in how people acquire their hearing aids, impacting both the cost and convenience of purchasing them.
Let’s take a closer look at the Over-the-Counter Hearing Aid Act and explore its implications on accessibility to over-the-counter (OTC) hearing solutions.
Table of contents
- What are OTC hearing aids?
- Are OTC hearing aids available now? How the law has changed
- What the OTC hearing aid rule means for consumers
- OTC hearing aids vs. prescription hearing aids
- Where to buy OTC hearing aids
- Does health insurance cover OTC hearing aids?
- Find hearing aids that are right for you
What are OTC hearing aids?
OTC hearing aids are an alternative option to prescription hearing aids. They are sold directly to consumers without needing a prescription or an exam from an audiologist or other hearing professional. These hearing aids are designed to be affordable and accessible to people with perceived mild or moderate hearing loss. According to the National Institute on Deafness and Other Communication Disorders (NIDCD), OTC hearing aids are not suitable for children under 18 or anyone with more severe hearing loss. The U.S. Food and Drug Administration (FDA) regulates OTC hearing aids as medical devices to ensure their safety and effectiveness.
There are a variety of OTC hearing aids and devices available that vary in design and features. Personal sound amplification products (PSAPs) are also available over the counter, but they are different from hearing aids. PSAPs amplify sounds for those with normal hearing while hearing aids are intended for those with impaired hearing.
Are OTC hearing aids available now? How the law has changed
As of Oct. 17, 2022, OTC hearing aids are available for over-the-counter purchase in the U.S. due to the Over-the-Counter Hearing Aid Act. This marked a significant shift in the hearing aid industry.
The FDA’s ruling on OTC hearing aids has significant implications for the hearing healthcare industry. The regulation allows individuals with hearing impairment to purchase hearing aids without obtaining a prescription from an audiologist or other health care professional. Before this, consumers were required to visit a hearing professional to purchase prescription devices. The ruling aimed to increase the accessibility and affordability of hearing aids to the estimated 37.5 million Americans with hearing loss.
OTC hearing aids are regulated by the FDA and must meet certain standards in terms of effectiveness and safety. While they don’t offer the same level of customization and personalization as prescription hearing aids, they can still improve the quality of life for those with mild or moderate degrees of hearing loss. Nevertheless, it remains important to consult with a healthcare professional to establish whether an OTC hearing aid is suitable for your unique hearing needs.
The provisions to the historic rule
Congress has clarified that OTC hearing devices are only for adults, and the new rule creates labeling requirements warning against their use for those under 18.
To ensure that these medical devices are safe for consumers, the FDA has established a set of requirements that OTC hearing aids must meet before they can be sold to the public. These requirements regulate factors such as sound amplification, battery life and labeling instructions.
For example, the rule sets maximum output limits for OTC devices to ensure volume levels don’t damage users’ ears. The FDA’s rule also includes specifics on device design, including setting a maximum insertion depth to ensure that devices remain a safe distance from the user’s eardrums. In addition, OTC devices must have labels that inform potential consumers about the device’s intended use, benefits and potential risks.
What the OTC hearing aid rule means for consumers
The ruling on over-the-counter hearing aids represents a significant step in helping a long-standing public health problem — limited access to quality hearing devices — through a market-shaping strategy. The regulations opened up a new market for hearing aids, providing a clear pathway for major healthcare and tech companies to create innovative hearing aids that revolutionize the industry as a whole.
The demand for high-end OTC hearing aids will continue to grow, and this new law creates an exciting opportunity for tech companies to meet that demand.
We’ll discuss a few other fundamental changes and considerations that result from the ruling below.
You can obtain hearing aids without a prescription or hearing exam
Most insurance plans don’t cover the costs of hearing aids. As a result, many customers have long been paying out-of-pocket for their prescription hearing aids and exams. Because of the high cost of these devices, many Americans could not get the hearing health care they needed.
But now, for the first time, consumers can obtain hearing aids without needing a prescription or a hearing exam. This change could potentially impact individuals with hearing impairments by providing them with more affordable and accessible options. The National Council on Aging (NCOA) estimates that OTC hearing aids can save customers as much as $3,000 compared to prescription hearing aids.
People now have access to more affordable hearing aids
Those with hearing loss have historically underutilized hearing aids. The National Institute of Health (NIH) estimates that fewer than a third of adults who could benefit from hearing aids have ever used them.
In the past, those who needed hearing aids would have to pay for a specialist to receive the prescription and pay for the hearing aid itself, which was often quite costly due to the customization. The new ruling allows for more affordable options.
Hearing aid users must do their due diligence when shopping
Even though it’s much easier to get hearing devices now, make sure to look for devices that are FDA-approved OTC hearing aids. Doing the proper research before purchasing an OTC hearing aid can help you avoid counterfeit or low-quality products.
Potential customers and hearing aid users will need to conduct in-depth reviews and research into hearing aids and their overall ear health. Look for reviews online and ask for recommendations.
Then, consider the type of hearing loss you have. This will determine the level of amplification you need in a hearing aid. You should also think about your lifestyle and daily activities. Do you frequently attend loud events or need to communicate in noisy environments? Then you may require a different type of hearing aid than someone who primarily spends time in quiet settings.
Additionally, consider the different features you require. For instance, some OTC hearing aids offer more advanced features, such as noise reduction and speech enhancement.
OTC hearing aids vs. prescription hearing aids
Determining whether OTC or prescription hearing aids are better depends on your specific hearing situation, needs and budget.
OTC hearing aids are often less expensive than prescription devices but may not provide the same level of customization. Prescription hearing aids are customized to the individual’s specific hearing needs and are only available through a hearing health professional. Compared to OTC hearing aids, they can often provide a wider range of features than OTC devices — such as directional microphones, noise-canceling technology or sound amplification that adjusts automatically to different environments. Many newer models also boast extended battery life and durability. However, some of these features are available on certain OTC devices.
So, while OTC hearing aids are now easily accessible, prescription hearing aids may ultimately be the better choice for some users needing advanced features. For those with severe hearing loss, the best hearing aids are prescription hearing aids, while those with mild hearing problems can utilize either OTC or prescription hearing aids.
Where to buy OTC hearing aids
If you are in the market for OTC hearing aids, there are a few key places to start your search. First, they’re available at many big-box retailers, such as Walmart, Target or Costco. These stores often carry a range of affordable, FDA-approved hearing aids that may fit your needs.
Another option is to purchase hearing aids online from specialized hearing aid retailers and brands. These retailers offer a wide selection of options and typically have knowledgeable staff who can guide you through the purchasing process.
If you want to balance affordability and medical expertise, you can check out popular pharmacies, like Walgreens or CVS. These stores can typically give you a hearing consultation and assessment and offer several relatively affordable options for OTC hearing aids.
Does health insurance cover OTC hearing aids?
Insurance coverage for OTC hearing aids varies by provider and plan. While some plans offer some coverage, most insurers do not cover the costs of OTC or prescription hearing aids.
Unfortunately, Original Medicare doesn’t cover the cost of hearing aids or hearing exams, although certain Medicare Advantage policies may offer limited coverage.
As OTC hearing aids become more widely available, there is a growing need for insurance companies to reevaluate their coverage policies. You should carefully review your insurance plan and speak with your provider to determine if coverage is available for OTC hearing aids.
Find hearing aids that are right for you
As OTC hearing aids become increasingly available, more people have the opportunity to manage their hearing loss affordably. But not all OTC hearing aids are created equal, so you must research your options before purchasing to find the best devices for you.
Consider factors such as sound quality, amplification, comfort and battery life when searching for new OTC hearing aids. It may also be helpful to consult with a hearing healthcare professional who can guide you in making the best decision for your unique needs. Ultimately, the type of OTC or prescription device that will work best for you depends on your hearing needs and preferences.