If you've been searching for hearing solutions, you've probably come across a lot of options. One type of hearing device, called personal sound amplification products, or PSAPs, is generally a low-cost option. And yet another product has recently been making headlines: over-the-counter hearing aids, or OTC hearing aids. But what exactly are these types of hearing devices, and how do they differ from traditional hearing aids?
It’s likely that you’ve recently seen news coverage about a different class of products: over-the-counter hearing aids, or, in shorthand, OTC hearing aids or OTC HAs.
In August 2022, the United States Food and Drug Administration (FDA) issued a final rule to allow the purchase of these types of hearing aids directly from stores and retailers.
The action has been a long time coming. In 2017, Congress passed the FDA Reauthorization Act that required the FDA to create a category for OTC hearing aids. The act carried the provision that once regulations were in place, this type of hearing aid would be available to the public and could be marketed as a hearing loss solution.
The establishment of this new category gives consumers an entirely new option, but it’s still important to be aware of exactly what you’re getting with this type of hearing device, compared to PSAPs and regular hearing aids.
Each type of hearing device comes with its own benefits and drawbacks. By understanding the differences, you can better determine which might offer the support you need to navigate your hearing loss.
PSAPs are simple devices that amplify sounds for the wearer. These devices are not FDA regulated and are not considered to be medical devices, as they are designed to "increase environmental sounds for non-hearing impaired customers". In comparison, hearing aids are FDA-regulated medical devices specifically for people who have hearing loss, and they are customized to treat the wearer's specific hearing loss needs. OTC hearing aids are FDA-regulated as well, but they are not customized by a professional.
Most PSAPs amplify all sounds within a given radius, even those you don't want to hear. This can potentially be useful if the user has normal hearing, but needs some environmental sounds amplified when watching TV or listening to a speaker. However, when all sounds are amplified, distinguishing between sounds in a crowded or noisy environment can be vitually impossible; it can even create more barriers to hearing sounds clearly.
Hearing aids, on the other hand, use broadband technology and filters to selectively amplify the sounds the user needs to hear, while reducing background noise and feedback. This significantly minimizes any distracting noises to help increase speech understanding in busy environments.
OTC hearing aids are more finely tuned than PSAPs, and all models are required to have user-adjustable volume control, but they offer less customizable options for adjusting to different sound environments.
Most PSAPs only consist of a microphone, amplifier and receiver (mini-loudspeaker). In addition, they are only available in standard settings and are typically one size fits all. Hearing aids, however, are custom-programmed by a hearing care professional to suit your specific hearing loss and listening needs. Hearing aids are available with advanced features such as directional microphones, tinnitus control and streaming capabilities. They can also be custom-molded for a secure and ultra-comfortable fit.
Hearing aids are also made up of those three essential parts, but most models include additional technology that can be custom programmed by a hearing care professional to meet the wearer's specific hearing loss needs and lifestyle choices. This technology includes advanced features such as directional microphones, noise management, feedback cancellation, tinnitus controls, streaming capabilities and more. Customers also receive ongoing aftercare to ensure their hearing aids fit properly and that their hearing aid programs are turned correctly for optimal results.
With OTC hearing aids, there are shared characteristics of both, but what you get depends on where you make your purchase. Like PSAPs, they're not customizable and are meant for immediate wear without a full fitting or consultation. The amount of support you receive can differ. Miracle-Ear's OTC hearing aid, SimpleSound, can be purchased in store, giving buyers the opportunity to consult with a hearing care professional before taking their devices home.
Because they aren't medical devices, the greatest risk associated with PSAPs is that, despite the fact that they aren't intended to treat hearing loss, many people attempt to use them for that purpose.
Given the one-size-fits-all approach and lack of follow-up care, customers may end up using the devices incorrectly in ways that put their hearing at risk. The design of the ear inserts on PSAPs can push earwax deep into the ear canal, causing earaches and increased hearing loss. And without the support of a hearing care professional or the ability to calibrate sound, users might simply turn their PSAPs up louder, which can ultimately result in greater damage and hearing loss.
Before the FDA finalized its rule on OTC hearing aids, it took public comments, some of which led to changes to the final rule. Among them were revisions that addressed some of the problems with PSAPs, such as lowering the maximum sound output to reduce the resk of over-amplification, and limiting the insertion depth in the ear canal.
However, with both PSAPs and OTC hearing aids, buyers receive these devices without a full physical evaluation for a hearing care professional, meaning that conditions related to hearing loss can go unaddressed. Not only could that affect the effectiveness of their chosen solution, it could lead to further health complications in the future.
Purchasing hearing aids is an investment in both your hearing health and your overall wellbeing, and it requires careful consideration. When it comes to choosing the best type of hearing device for you, here's a good rule to follow: Proceed with caution when buying any product for a hearing loss - regardless of how it's classified - unless it is fitted by or offers support from a hearing care professional. This will ensure that the device is safe and that your specific needs are accounted for.