Hearing aids have been in the news recently, due to the long-awaited finalization of the FDA’s regulations concerning over-the-counter hearing aids. We’ve been seeing a lot of misconceptions in the way this change has been talked about, though, so this post will cover what you really need to know! It will also cover Earlux’s position on the new product offerings, and how we intend to handle the changes.

What Actually Happened?

In August, the U.S. Food and Drug Administration (FDA) finalized regulations creating a new category of over-the-counter hearing aids. This was the long-awaited outcome of legislation that was passed in 2017; the Over-The-Counter Hearing Aid Act of 2017 was originally supposed to take effect in 2020, but with the Covid-19 pandemic the FDA was rather busy and had to push back the creation of these regulations. Now, in 2022, the regulations have been finalized and will take effect in mid-October. 

Contrary to some coverage we’ve seen, this rule does not remove the role of the audiologist or make available the current, high-quality, prescription hearing aids you may be familiar with. Prescription hearing aids will still be available only by prescription, and the process for obtaining them is not affected by the new rules. Instead, the rule creates a new category of hearing aids, which will meet certain requirements set out by the FDA, and which will be available without the traditional process. They will be different devices, and they will be appropriate for a certain subset of people with hearing loss, but they won’t be for everyone. They are a supplement to the current way of getting hearing help, not a replacement.

What’s available right now?

Another misconception is that there aren’t already hearing devices available over-the-counter. There are, and there have been for many years. Because the FDA didn’t regulate these devices, they weren’t legally permitted to be marketed as “hearing aids,” and they were often seen to carry strange warnings suggesting that they were for the enhancement of normal hearing, not the treatment of hearing loss. These devices were known as Personal Sound Amplification Products, or PSAPs. You can go to drugstores or online retailers right now and find them at price points ranging from about $15 up to several hundred dollars, and the quality varies wildly and can’t be predicted by the price. 

For people who absolutely cannot afford prescription hearing aids, these devices can be a lifesaver. Something is almost always better than nothing, and some of these devices aren’t even that terrible. However, most of them amplify all sounds indiscriminately, leading people to complain that everything is now too loud but still unclear. There is no guarantee of any sort of quality because they’re unregulated, and – more disturbingly – there’s also no guarantee of safety. Some of these devices could further damage your hearing by putting out an unsafe level of sound; for example, all prescription hearing aids have output limiters built into them so that if a fire engine passes next to you with its siren blaring, the hearing aids will not amplify that siren to dangerous levels, but PSAPs often don’t have such limiters and may make that siren so loud that it does instantaneous, irreversible damage to your hearing. 

Prescription hearing aids, of course, have also been available for decades. These are the high-quality but pricey devices that you get from specialty clinics. You start by going in for a comprehensive hearing test, followed by a consultation with a professional to determine which devices best meet your needs. When you purchase prescription hearing aids, they will be precision fit to your exact hearing profile by your audiologist or hearing instrument specialist, and they will almost always come with unlimited follow-up care so that they can be fine-tuned as much as needed to get them just right for you. PSAPs come with no professional care at all, don’t require a hearing test, and may or may not be a reasonable fit for your hearing loss.

What will be available when the new rules take effect?

As we previously stated, the new rules will NOT make prescription hearing aids available over the counter. They will, however, allow certain PSAPs to be marketed as hearing aids if the PSAP meets the new FDA guidelines for quality and safety. Some PSAPs will therefore simply change their branding and become “hearing aids.” Other products will be entirely new. Because the legislation creating this category was passed five years ago and was in the works for a number of years before passing, companies wanting to get into the OTC hearing aid game have had a long time to develop their products. Presumably, some of these devices will be released just as soon as the rules take effect in October. 

Any device marketed as a “hearing aid” under the new regulations is meant only for adult users (18+) with “perceived mild to moderate hearing loss” and no medical symptoms such as sudden hearing loss, one ear that is better or worse than the other, pain or drainage in the ear, dizziness, tinnitus (ringing/buzzing), or a history of ear or head trauma. We would also argue that someone looking to purchase OTC hearing aids should also be reasonably tech savvy, with good manual dexterity and close-range eyesight in order to troubleshoot their own hearing aids, considering the lack of professional support. 

What’s the difference between PSAPs, OTC hearing aids, and prescription hearing aids?

The below table summarizes the main differences between the three categories:

PSAPOTC Hearing AidsRX Hearing Aids
Over the Counter?YesYesNo
Available Online?YesYesYes, through virtual clinics or with contracted local support
Requires Hearing Test?NoNoYes
Professional Fit?NoNoYes
Comes with Service/Support?NoMinimal Yes
Appropriate for Severe Hearing Loss?NoNoYes
Appropriate for Mild to Moderate Hearing Loss?NoYesYes
Regulated for Safety?NoYesYes
Appropriate For Minors?NoNoYes

Other differences, such as the specifics of features such as Bluetooth, rechargeability, or telecoils, depend on the exact model of the device and cannot be generalized to the category. When you’re being fitted for a prescription hearing aid, your hearing care professional can help guide you to the hearing aid that best suits your needs. With PSAPs and OTC devices, you’ll need to do your own research if these features are important to you.

Generally speaking, we would summarize the three products this way:

  • PSAPs are unregulated over-the-counter products that just make everything louder. Legally speaking, they aren’t even appropriate for people with hearing loss!
  • OTC hearing aids are FDA-regulated products of somewhat higher quality that are designed to help hearing loss, but may or may not be appropriate for your hearing needs.
  • Prescription hearing aids are the gold standard, will be precision-fit to your hearing loss, and come with professional support. However, they are the most expensive option.
  • An analogy: PSAPs are hand-held magnifying glasses. OTC hearing aids are drugstore reading glasses. And prescription hearing aids are quality prescription bifocals or trifocals from your optometrist.

Which category is right for you?

We’re just going to dismiss PSAPs out of hand. They are not designed as a treatment for hearing loss, and most of them do not help (especially since the ones that meet the new guidelines will be rebranding themselves as OTC hearing aids, leaving only the worst ones behind). But the choice between OTC hearing aids and prescription hearing aids is a legitimate decision; you wouldn’t have read this far if you didn’t want hearing help, and the landscape was already confusing even before the new rules were finalized. 

Prescription hearing aids are expensive. We at Earlux are able to offer competitive pricing because our remote/virtual service model reduces our overhead, and we pass that savings on to our clients. However, we won’t deny that hearing aids are still a significant investment! Millions of Americans have untreated hearing loss because that investment is just too much for them, and/or because they don’t feel that their problem is great enough to be worth the cost. The hope is that over-the-counter hearing aids will help to fill this need and help the people who aren’t currently being helped by prescription hearing aids.

OTC hearing aids will be available to adults (18+) with “perceived mild to moderate hearing loss.” The key word here is perceived. Mild to moderate is actually a technical term, specifically meaning the ability to just barely detect sounds between 25 and 55 decibels. Most folks have no idea what 25 to 55 decibels sounds like, and their hearing problems have crept up on them so gradually that they don’t really notice how much they’re missing until their friends and family start to complain. There are quite a few studies proving that people are pretty bad at self-diagnosing their degree of hearing loss. Our position, therefore, is that even if you’re intending to purchase OTC hearing aids instead of a prescription, you still need a hearing test. At a minimum, you can take our online screening here. If your results indicate a mild hearing loss, you may be a good candidate for OTC hearing aids. If your results say your loss is “significant,” you will probably be better served by prescription aids.

You may be best served by OTC hearing aids if you fit this description:

  • You are 18 or older
  • You have no medical history or red-flag symptoms as discussed earlier
  • You struggle to understand what people are saying in noisy environments or if they’re speaking from far away, but you do fine in one-on-one conversations
  • Your online hearing test indicates a mild hearing loss
  • You’re reasonably tech-savvy and can manipulate small parts without trouble
  • Budget is a concern for you, and you’re willing to accept lower quality and forgo professional care in exchange for a lower price
  • You know you’ll need good hearing aids one day, but don’t feel ready just yet

You may be best served by prescription hearing aids if this is you:

  • Your hearing loss is worse in one ear, you have tinnitus or dizziness that has never been evaluated, or you believe your hearing loss to have been caused by anything other than normal aging (disease, trauma, medication, etc.)
  • Your online hearing test indicates significant hearing loss; if your online test indicates mild or moderate hearing loss, you may also do best with prescription hearing aids, but significant loss rules out using OTC devices.
  • You have a hard time hearing in small group conversations, one on one interactions, or you have to use closed captioning on your TV. Noisy environments are so hard that you feel like giving up. (These are indications that your hearing loss is more severe than what OTC hearing aids are designed for!)
  • You value the involvement of a hearing care professional who can answer questions, physically inspect your ears, and counsel you as you adapt to using hearing aids, and who will be available if you have concerns going forward
  • You spend a lot of time in complex listening environments and the ability of the hearing aids to filter out background noise is important to you
  • Sound quality is important to you; after all, you’ll be wearing these all day, so you want them to sound good!

What Earlux offers

Earlux is a virtual hearing health company offering high-quality prescription hearing aids with full service from licensed, experienced audiologists. We strive to meet the gold standard of audiologic care via a virtual (telehealth) model that allows us to bring the clinic to you, rather than the other way around. We believe that both the care and the quality of the product are important to achieving the best outcomes for our patients.

That being said, our raison d’etre is helping people hear. We believe that in a world where options abound and where many of those options don’t serve people well, our mission is to provide people with the options that will best serve them. And not all people are best served by prescription hearing aids. Our position, therefore, is that the advent of over-the-counter hearing aids is a good thing rather than a threat. OTC aids will allow a greater proportion of the hearing-impaired population to be served compared to prescription alone, and they will also provide a glide path for those who will need prescription aids but who aren’t quite there yet, much as drugstore reading glasses can help people who don’t yet need bifocals. 

Earlux is therefore planning to offer over-the-counter hearing aids in addition to prescription hearing aids. We are closely watching upcoming product releases so that we can add products that meet our high standards to our existing product line. At the present time, we are pleased to offer the Jabra Enhance Plus, an earbud-style OTC aid from a trusted manufacturer which meets our standards of excellence. This device doesn’t require a fitting appointment with our audiologist, nor does it include audiologic care or follow-up: you order it, you set it up, and fit it yourself, and you’re all set. In the future, we plan to add more such products. And we will continue to offer high-quality prescription hearing aids with full professional service included. 

Interested? Start with our online hearing screening Here. Questions? Call 1-833-4-EARLUX. We’d love to help you hear better!