New Normals; New Confusions
Now more than ever, consumers are looking for products to arrive at their doorstep, including hearing aids. With new legislation rolling out this month, there is a lot of noise in the hearing aid marketplace, which obscures the key differences between these very different products.
This month, the FDA is scheduled to release a draft of regulations for Over-the-Counter hearing aids as part of the FDA Reauthorization Act. President Trump signed FDARA into law three years ago, which covers a range of new regulations. However, I am most interested in the new regulations for medical devices which allow the first development of FDA approved Over-the-Counter hearing aids—a pursuit to make hearing aid technology more affordable and accessible. Or so they say.
With the confusion surrounding this development, my aim is to reduce some of the noise and help you understand what is going on and how it may impact the world of hearing aids for the better, and possibly for the worse. In my estimation, 80% of the folks I see in my clinic with hearing loss are candidates for hearing aids. The hearing aid journey is already so daunting due to stigma, denial, and cost, that demystifying these distinctions is important if people are going to hear better.
OTC Hearing Aids: Something We’ve Never Seen (or heard) Before
Until now, hearing aid consumers were required to have medical authorization in order to purchase hearing aids—not to be confused with PSAPs, personal sound amplifying products, which only enhance sound and are no solution for hearing loss. PSAPs are considered Direct-to-Consumer products and are not regulated by the FDA. You can find PSAPs online or at pharmacies, Walmart and the like. Technically, this term—Direct-to-Consumer—defines any item a consumer purchases directly without the use of a middleman or a retailer. And, in the case of DTC hearing devices as of now, without the use of a physician or FDA approval.
The DTC hearing device marketplace is wildly unregulated. In fact, hearing aid manufacturers have made false claims that their DTC hearing devices are official OTC hearing aids. However, hearing aids are still considered restricted devices—products that must be distributed by a licensed professional. The FDA stated that any product claiming OTC hearing aid status is false because that category doesn’t exist yet. This was published in their letter to hearing aid manufacturers in July of 2018. Unfortunately, while the FDA is aware of this mislabeling, they haven’t enforced their own guidelines—this is cause for concern and confusion when OTC hearing aids become legitimate. Regardless, any DTC product claiming to address hearing loss as an OTC hearing aid is not to be trusted.
However, everything changes this month! Supposedly, the FDA will decide the criterion for products to be able to claim OTC hearing aid status on August 18th. Then there will be a time for the public to contribute comments. I suspect these official products will not hit the market until the end of this year, at the earliest. My hope is that the FDA will enforce their guidelines so that the DTC hearing aid market has a fighting chance to be considered a legitimate option for people.
FDARA also includes the authorization of self-fitting hearing aid technology, so that electronic companies—like Bose, Samsung and Apple—can create devices that sync with mobile apps, giving the consumer total control of their hearing aid . . . and their hearing loss. While Bose is authorized to market their hearing aid products, I doubt these tech companies will be able to release their new products soon. I’m really not sure how these products will relate to today’s standard hearing aid; I have no idea how much they will cost and what kinds of support their companies will offer. I predict we will see more existing hearing aid manufacturers creating OTC versions before these tech companies will—simply because of their familiarity with hearing aid production.
Perception vs. Reality
The new OTC category will aim to treat “perceived mild to moderate” hearing loss. In my clinic alone, many people falsely perceive their hearing loss, so I’m leery of this self-help approach. I’m especially concerned for people with actual severe hearing loss who decide to go the OTC route, and then abandon hearing aids altogether when their OTC hearing aids cannot treat their severe hearing loss. Also, OTC devices will come pre-programmed, which leaves a large margin for error. This will lead to dissatisfaction since consumers won’t have access to correct and adjust settings. Again, this will encourage the wrong perception of what hearing aids can offer a person with hearing loss.
Individual Issue; Collectively Solved
Your hearing loss could not be more individual, and while hearing aids work, they require the nuance of time, counseling, and professional expertise to fit your ear and your hearing need. Hearing aids succeed to the degree they are customized, from measure of loss to ear anatomy. A professional hearing aid servicer/provider will manage the feedback, noise, quiet, comfort, overall fit, earwax buildup, moisture, itching and guarantee that your hearing aid does the job it is supposed to do. On average, people wait 7 years to purchase hearing aids after realizing they could benefit from them. In that time, their hearing has declined, and their brain has actually formed new pathways for existing in the world, strengthening other senses while naturally weakening others. Therefore, it takes new hearing aid wearers time and counseling from a professional to establish a new normal. Frankly, this isn’t a process that most people could figure out on their own.
Untreated Hearing Loss is Mistreatment
It’s unlikely that OTC hearing aid usage will cause direct harm; I suspect people won’t wear them if and when they hurt or don’t help. While I certainly support responding to pain, I fear people who could really benefit will throw away the worth of hearing aids when they quit their OTC pair, prolonging untreated hearing loss.
Untreated hearing loss is a serious health condition, especially as people age, leading to cognitive decline, depression, and falls. While many insurance companies and Medicare fail to support the gravity of this health issue, hearing loss is the third most common chronic physical health condition—more chronic than diabetes and cancer. Treatment seems expensive, but unaddressed hearing loss poses an annual global cost of $750 billion. Nothing to sneer at!
Additionally, like other physically losses, untreated hearing loss perpetuates itself; it’s not stagnant. Therefore, the longer a person waits to treat their hearing loss, the worse their hearing loss becomes. Likewise, the longer a person waits to purchase hearing aids, the longer a person needs to acclimate to the treatment with the nuanced help of a professional.
The Value – Something You Can Hear
In conclusion, I understand that now more than ever, the convenience of having something shipped to your doorstep carries a new weight. It’s not merely convenience; it’s safety. And, I certainly won’t underestimate the need to prioritize, both for your health and your finances. However, hearing loss is a serious and individual issue that requires the specialized care and counseling of professionals—that can’t be boxed! Even so, we are galvanized to move with the new normal and have found great success with programming hearing aids remotely.
As the options grow with the regulation of OTC hearing aids, do your research, get a second or third opinion, and always consider the source. When we listen, we can hear, and the value of personalized treatment is something you will actually hear.