By Sarah Sydlowski, AuD, PhD
Cleveland Clinic is a non-profit academic medical center. Advertising on our site helps support our mission. We do not endorse non-Cleveland Clinic products or services. Policy
Hearing devices are in the midst of a huge change to their delivery model.
Up to this point, hearing aids have been regulated as Class I or II medical devices by the Food and Drug Administration and must be dispensed by a licensed hearing professional.
There are also devices called personal sound amplification products (PSAPs) that are not intended to be used for hearing loss and are not allowed to be marketed for hearing loss. Instead, they are usually marketed for “hearing enhancement.” PSAPs are readily available in drug stores and online and can be purchased without a prescription or a hearing evaluation.
A new type of hearing device
In 2017, the FDA Reauthorization Act was signed into law. It included a clause that requires the FDA to create a new category for hearing devices called over-the-counter hearing aids (OTC HAs), for people with self-perceived mild-to-moderate hearing loss. This new class of products will be able to be marketed for hearing loss but will be available without any kind of prescription or the involvement of a licensed professional. The regulations must be in place by 2020.
By that time, there will be hearing aids, PSAPs and OTC HAs on the market.
The FDA recently approved what will likely become one of the first OTC HAs. It’s a fully self-programmable hearing device (meaning the user can fit, program and control it without the assistance of a professional) developed by the electronics company Bose, who has not normally been a player in this market. The approval of this product was interesting because the FDA granted the company approval to market something that might have previously been considered a PSAP as a hearing aid. Right now, it is still subject to the constraints of traditional hearing aids (it must be dispensed by a licensed professional). But when the OTC HA classification goes into effect, it will in prime position to be one of the first OTC HAs to hit the market.
While some traditional hearing aids allow patients to make adjustments using their smartphones (like increasing or decreasing bass or treble), to completely program the device without the expertise of a professional is an entirely new approach to hearing devices. Empowering individuals to select and fit their own devices has the potential to improve access to hearing devices. But if the devices are used incorrectly, they may not only fail to help those with hearing loss but may even prevent those people from seeking the help that they need.
What an audiologist brings to the table
Traditional hearing aids are programmed by a licensed professional, such as an audiologist. The importance of this step can’t be overemphasized.
Most people look at hearing aids as a commodity – a product. They think about buying a device and putting it in their ear. For that reason, many people think hearing aids are all more or less the same, so they “shop around” and are highly influenced by cost. In reality, there isn’t much differentiation between hearing aid companies – there are many options that could be equally appropriate for any one person. But where there is the potential for huge differences is in how the device is programmed to adjust and improve the person’s hearing. If an inappropriate device is selected, or it isn’t programmed correctly, not only might the device not provide benefit, but it could actually be harmful.
Audiologists are doctoral-level professionals who have the expertise to correctly diagnose the type and degree of hearing loss and a person’s candidacy for hearing aids. An audiologist can also help people identify the right device, optimize the fit, program the device correctly, counsel on expectations and discuss other assistive listening devices.
You can recognize an audiologist by the degree designator AuD, PhD, or in some cases MA or MS. Some audiologists may additionally display the designators ABA certified, CISC or CCC-A. An audiologist will evaluate your hearing to determine if a hearing loss exists and can recommend the right device for you, including traditional hearing aids, OTC HAs or, in some cases, implantable hearing devices.
Outlook for over-the-counter hearing aids
Although OTC HAs may have a very appropriate purpose for people with mild hearing loss, working with a qualified audiologist will still be the most appropriate option for the majority of people with hearing loss.
Hearing loss is often progressive, and although it may begin as a mild loss, it may not stay that way. Also, there is very little scientific evidence that people can accurately identify the degree of hearing loss they have. So, although someone may think they have mild hearing loss, if it is actually greater than that, they may be at risk for under-fitting their hearing aid and not getting adequate gain or benefit from the device.
I frequently work with patients using hearing aids who are shocked to see their hearing capability increase 50 percent or more simply by having hearing aids that are appropriate and fit correctly. Often they have no idea that they could be hearing better and are surprised to find the benefit that can be achieved with thorough evaluation and knowledgeable fitting of a device.
In my opinion, that is the greatest concern with OTC HAs. I’m confident there will be adequate protections in place to prevent someone from over-amplifying their hearing (using too strong of a device and causing further hearing loss). But there is a not a good way to protect against people opting to use a less-than-adequate device. Unlike eyeglasses, where if they are fit correctly, you see clearly, with hearing it is much less straightforward. People don’t know what they can’t hear, which is why so many people end up waiting years to seek help in the first place as their hearing slowly declines.
There is good research showing that hearing loss is somehow related to cognitive decline. Whether that is because hearing loss causes people to withdraw from social interaction or because of other reasons, we don’t yet know. But we do know that not managing the hearing loss or not managing it appropriately can have negative consequences.
OTC HAs have the potential to be a great addition to the wide range of devices that we have to offer. I would rather see people with mild hearing loss using them than nothing at all. But they are not a replacement for the expertise of an audiologist. Hopefully OTC HAs will become a good entry point to hearing aids for people who may have waited too long before they were available. But I hope that people do not view them as a replacement for the high-quality care of a professional.
Based on the media spots I’ve seen so far, I fear that OTC HAs are being portrayed as equivalent to traditional hearing aids at a lower cost. While OTC HAs may have the ability to perform similarly to certain hearing aids (we don’t yet know if this is true), it completely discounts the expertise that goes into choosing the right device. This includes making sure it fits the ear appropriately, adjusting numerous settings to achieve optimum performance, and monitoring of outcomes and changes.
OTC HAs are one end of a spectrum of hearing devices and will be a great option for the right candidates. But, I advise always having your hearing checked by an audiologist before deciding to proceed with any device. Paying less for a device that can’t help you hear your best isn’t a bargain – it’s selling yourself short on living your best life.
Dr. Sydlowski is board certified in audiology with specialty certification in cochlear implants. She has served on the board of directors of the American Academy of Audiology and is a past president of the Ohio Academy of Audiology.