The U.S. Food and Drug Administration (FDA) finally took the next big step toward expanding treatment options for hearing loss in October 2021. It proposed rules establishing a new category of over-the-counter (OTC) hearing aids that you can purchase without a prescription.
This FDA push toward making OTC hearing aids more accessible is a solution to the widespread issue of access in the U.S.
In its press release, the FDA notes that approximately 37.5 million American adults report trouble hearing. Yet only about 20% of people who could benefit from hearing aids are currently using the medical devices.
It’s hard to say exactly why the percentage of hearing aid use remains so low. But some experts attribute it to lack of access to an audiologist or hearing aid dispenser. Because the FDA currently regulates hearing aids as prescription medical devices, they have to be prescribed by a hearing professional.
Others believe the costs of the devices prevent many Americans from affording them.
OTC hearing aid availability could help address both of those concerns. Consumers will be able to purchase the hearing aids at retail and online outlets. However, while the Over-the-Counter Hearing Aid Act could help millions of people achieve better hearing, some experts still have concerns.
Here’s what you’ll learn:
- Are OTC Hearing Aids Currently Available?
- Am I a Good Candidate for Over-the-Counter Hearing Aids?
- Concerns With OTC Hearing Aids
- Final Thoughts: What Over-the-Counter-Hearing Aids Could Mean for You
We know some reading this may be confused. A quick search on Amazon will reveal dozens of products marketed as hearing aids or that use similar terms. But most OTC devices for hearing on the market right now aren’t FDA-approved and may not offer much help.
Technically, these devices are personal sound amplification products (PSAP) – not hearing aids – and can only amplify sound by about 20dB without picking up on specific frequencies.
Since PSAPs don’t differentiate between frequencies, they can make certain noises unbearable, and do little to help with difficult listening situations like competing speech. Background noise and the target sounds aren’t picked up differently by PSAPs.
That means many of those items actually do little to help with hearing loss.
Over-the-counter hearing aids were first seriously brought up with the FDA Reauthorization Act of 2017. The act aimed to address many drugs and devices for consumers, but hearing aids were largely ignored until October 2021.
It wasn’t until then that the FDA followed President Biden’s July 2021 Executive Order and announced its proposal to bring the OTC Hearing Aid Act forward. The FDA now has a timetable set up to help make over-the-counter hearing aids a reality.
Companies like Bose already have products ready to launch as FDA-cleared once rules are established. Those brands will likely work toward FDA approval as soon as they can.
So true OTC hearing aids – those that have the potential to make life-changing improvements for people suffering from hearing loss – aren’t available yet, but this new hearing aid category should be approved shortly. And many big brand companies have already shown an interest in the OTC hearing aid market.
It’s important to remember that while OTC hearing aids should be available soon, it doesn’t mean they’ll be the right hearing loss solution for everyone.
In anticipation of the OTC Hearing Aid Act passing, experts have conducted studies to determine how successful the new products might be in helping Americans with hearing loss. Most experts agree that OTC hearing aids will work best for people who:
- Have previous experience with traditional hearing aids
- Are between the age of 18-60 (some older adults may be successful, but they may need assistance at first)
- Are able to use smart devices — many OTC models are tested with apps or Bluetooth connectivity
- Have mild to moderate hearing loss
Children with hearing loss, adults with severe hearing loss, and anyone with compromised cognitive ability (especially patients with dementia or health issues that affect brain function) will still need to see an audiology professional to have hearing aids fitted. An audiologist will ensure the best treatment outcomes for these groups.
Because the final rules of the OTC Hearing Aid Act aren’t available yet, options like required hearing tests or recommended follow-up treatment with an audiologist haven’t been determined.
While the introduction of over-the-counter hearing aids will hopefully increase usage and lower costs, the devices will still likely bring challenges for users. The Hearing Loss Association of America (HLAA) filed comments to the FDA on its recent proposed rule.
Here are some of the major concerns that doctors, hearing loss organizations, and other professionals have expressed about OTC hearing aids:
- Fit: One of the biggest concerns audiologists have is proper fitting. If hearing aids don’t sit well in the ear, users may incorrectly assume the devices don’t work well and quit using them.
- Consumer protection: As we mentioned earlier, many of the devices being tested so far require pairing with a smartphone or similar device. Some organizations are pushing for clear labeling, so consumers know if they’ll need a phone to set up their hearing aids.
- Quality control: While many hearing aid manufacturers have shown interest in the OTC market, so have many electronics manufacturers with little to no experience in hearing aids. It will be important to help consumers find which brands are FDA-approved and actually help with their degree of hearing loss.
- Missing underlying health problems: Hearing loss is associated with several acute and chronic health conditions, including concussion, diabetes, and heart disease. Because consumers won’t receive a thorough assessment by a hearing health care provider before purchasing OTC hearing aids, it’s possible that more serious health issues could go undiagnosed.You should still see a doctor before getting fitted for a hearing device if you experience:
- Sudden hearing loss
- Severe hearing problems
- Hearing loss in only one ear
You should also consult a health care professional if you’re under 18.
- Optimal use: OTC hearing aids may not need to be fitted by an audiologist, but they aren’t as simple of a solution as something like reading glasses.Your brain will still need to adjust to the new sounds OTC hearing aids provide, and that can be difficult without assistance. LACE Auditory Training can help you get the most out of your hearing aids. But if you’re still struggling, it’s important to speak to an audiologist.
As the FDA moves toward opening the market for OTC hearing aids, it could mean big changes in how hearing loss is treated in America. It’s even possible the devices will be available before the end of 2022.
Over-the-counter hearing aids could mean fewer doctor visits and less expensive devices. But they could also lead to patients not knowing how to fit the devices properly and larger health issues being misdiagnosed.
Whether or not you use or plan to get a listening device, you can include LACE in your hearing health routine to improve your listening comprehension. Training your brain to focus on what you’re listening to can help, even when the sounds are difficult to hear.