Are Over-the-Counter Hearing Aids Currently Available and Are They Safe?

Americans may soon be able to buy over-the-counter (OTC) hearing aids without an exam or fitting by a hearing health care professional. These lower-priced OTC hearing aids won’t be much bigger than a true wireless earbud, and will be a lot less expensive than a prescription hearing aid. However, there is some confusion about the approval process and what is currently available OTC, as I will explain.

Hearing Aids are Costly and Can Be Challenging to Obtain

Traditional FDA-regulated hearing aids, available only by prescription, range in price from around $1,000 to over $14,000 per pair, and most insurance plans offer only partial coverage. Medicare doesn’t cover hearing aids at all. In fact, the original 1965 Medicare Act specifically excluded coverage of hearing aids — and this hasn’t changed.

It might not be so bad if all you had to buy was one pair of hearing aids that would last a lifetime, but hearing aids typically have an average lifespan of just five to six years, which means that a person diagnosed with hearing loss in their mid-50s can expect to purchase multiple pairs over their lifetime. This cost burden can be especially challenging for someone on a fixed income.

Hearing aids can also be challenging to obtain. To get FDA-regulated hearing aids, patients are currently required to see a licensed hearing professional and obtain a prescription prior to purchasing them. The initial testing and tuning of hearing aids may also require multiple trips to the audiologist, and the devices generally need to be rechecked at least annually (some audiologists recommend a recheck every six months, though that advice varies). Many people simply cannot manage to get to and from all these appointments with regularity.

Over the Counter (OTC) Hearing Aids Got FDA Approval in fall of 2021

The US Food and Drug Administration (FDA) formally proposed rules to establish the new OTC hearing aids category in October 2021. From there, stakeholders such as the American Academy of Audiology, advocates for people with hearing loss, and hearing-aid manufacturers had an opportunity to weigh in during an open comments period that lasted until January 2022. The FDA is now processing and weighing the recommendations expressed during that period. Sales of OTC hearing aids will officially begin by the end of this year. There is some confusion around this, as many people believe that OTC hearing aids are already available for sale. Here’s where the confusion lies:

  • The confusion lies in defining what exactly constitutes a hearing aid, as opposed to hearing-augmentation devices such as hearables and personal sound amplification products (PSAPs), which have been selling for years.
  • The major difference comes down to loudness and safety regulations: hearing aids can get louder, have more targeted frequency-range boosts, and must meet specific ANSI safety standards.
  • Hearables and PSAPs are generally limited to 20 dB of gain, and they boost broad ranges of sound instead of more specific frequencies—essentially, they’re quieter and clunkier.
  • Hearables frequently look more like earbuds, can connect to your devices via Bluetooth, and may include a self-administered hearing test.

Legally, anything that isn’t a hearing aid should not be used or marketed as one. According to the FDA, PSAPs “are intended for consumers with no hearing loss who want to make environmental sounds louder, such as for recreational activities like birdwatching or hunting.” The statement continues, “While the FDA regulates hearing aids as medical devices, such PSAPs are not medical devices.” The FDA doesn’t specifically mention “hearables” in its statement because that’s really more of a marketing term to describe PSAPs with additional connectivity or technology, but hearables fall under the same restrictions as PSAPs.

  • Some companies, such as Bose, sell their products only in states that allow devices designed in the same way as FDA-approved hearing aids to be sold as FDA-cleared hearing aids.
  • Companies such as Bose and Jabra have introduced OTC-ready hearing-aid devices with plans to expand availability as soon as the FDA’s rules are official. Others, such as hearing-aid company Phonak, are taking a wait-and-see approach, saying they are “evaluating all our options to determine if we will participate once OTC becomes law.”
  • Others work with telehealth doctors or allow customers to submit their doctor’s audiology report to purchase hearing-aid devices.
  • There are the less-scrupulous device makers, which exploit loopholes to sell PSAPs or hearables using the “hearing aid” term. Attorneys general from a few states — including Texas, as well as Georgia, Louisiana, Missouri, Ohio, North Carolina, and South Carolina — have released warnings urging people to use caution when buying these products.
  • Not all unregulated hearing devices are unsafe. According to Consumer Reports, although it is technically possible that hearing-augmentation devices used at full blast for long periods of time could cause further damage, it’s unlikely. However:
    • these devices will not amplify sound in a meaningful or useful way;
    • Because these devices may not come with support, patients might not receive any education regarding how to customize and acclimate to the new sounds;
    • This will frequently result in wasted money and, even worse, cause people to forgo the pursuit of medically guided help.

Lisa Vaughan, past president of the American Academy of Audiology, cautions that “an over-the-counter device will not be the solution for everyone. People who experience sudden hearing loss, or hearing loss in combination with newly onset symptoms such as chronic headaches, should be evaluated by a doctor to rule out other health conditions. In addition, OTC hearing aids should be used only by adults who are self-sufficient. Children, people with dementia, and people who are unable to communicate should only ever be fitted for a hearing aid by a medical professional.”

How Can You Protect Yourself Against Hearing Loss?

If you don’t have hearing loss, these are some ways to protect yourself:

  • Keep an eye on the volume at which you listen to music and movies, as well as the duration. The WHO recommends listening at no more than roughly 60% of mobile-device volume for no more than 60 minutes at a time.
  • Consider noise-cancelling or noise-isolating headphones if you ride the Metro or work in a noisy environment.
  • Track your listening habits similar to how you track your steps. Apple’s Noise Alert for Apple Watch and Headphone Notifications for iPhone, iPad, iPod Touch, and Apple Watch allows Apple users to track the combination of environmental exposure and headphone loudness in the Health App. When you reach your safe exposure limits, the app will ping you via notifications and, if you’re using compatible headphones or earbuds, well even reduce your volume accordingly.

Hearing Loss Can Lead to Dementia

In a recent study, Johns Hopkins followed 639 adults for almost 12 years and discovered that people with mild hearing loss had double the dementia risk; those with moderate hearing loss had triple the risk; and those with severe hearing impairment were 5 times more likely to develop dementia. Read more in my article on the subject.

Visit An Audiologist

Most hearing tests are conducted by an audiologist. You should make an appointment to visit an audiologist if you, or a loved one, suspect that you may have hearing loss. Common signs of hearing loss include needing the volume of the TV higher than other people around you, difficulty understanding speech, and trouble hearing people over the telephone. Ask yourself the following questions:

  • Do you often think that others do not speak clearly to you?
  • Does your family frequently complain about the volume level of your listening activities, such as the TV or music?
  • Do you sometime need to strain to hear conversations?
  • Do you have trouble hearing in noisy situations?
  • Do you say “what?” a lot during conversations, or ask people to repeat themselves?

Answering yes to any of the above questions means it is time to visit an audiologist.

Ask your General Practitioner

Some primary care physicians will offer a basic hearing screening when you go to your annual physical. There are two main ways that a primary physician can perform a very basic assessment your hearing — through a written questionnaire asking questions like those mentioned above, or through a whisper test. If your primary physician does not routinely conduct hearing screening, let your doctor know that you or a loved one suspect that you may have hearing loss. Your doctor made perform a screening or may refer you directly to an audiologist.

Planning for Your Future and Your Loved Ones

As you can see, getting your hearing tested and taking care of hearing loss is important.

It is also important to plan for your future and your loved ones, if you haven’t done so already.

At the Farr Law Firm, we help protect the family’s hard-earned assets while maintaining your loved one’s comfort, dignity, and quality of life by ensuring eligibility for critical government benefits such as Medicaid and Veterans Aid and Attendance. Please call us any time to make an appointment for an initial consultation.

Fairfax Elder Law: 703-691-1888
Fredericksburg Elder Law: 540-479-1435
Rockville Elder Law: 301-519-8041
DC Elder Law: 202-587-2797

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About Evan H Farr, CELA, CAP

Evan H. Farr is a 4-time Best-Selling author in the field of Elder Law and Estate Planning. In addition to being one of approximately 500 Certified Elder Law Attorneys in the Country, Evan is one of approximately 100 members of the Council of Advanced Practitioners of the National Academy of Elder Law Attorneys and is a Charter Member of the Academy of Special Needs Planners.