“As various industry voices debate the nearing reality of FDA-regulated over-the-counter hearing devices, here is one personal perspective from one of Audigy’s many in-house experts.”
With passage of the 2017 FDA Reauthorization Act that includes creating a new class of FDA-regulated hearing devices, change is coming to the consumer market in the not-too-distant future. Are these devices — specifically for adults with self-perceived mild to moderate hearing loss — an inevitable bane for independent hearing care providers? Absolutely not! Here are four ways to embrace OTCs and win.
Make Your Voice Heard
Though they’re coming, the new category of OTC hearing devices isn’t here yet. The Food and Drug Administration hasn’t even released guidance or draft regulations on this new class of hearing technology, and that means you’ll still have a chance to provide valuable feedback — likely in 2020.
What kinds of comments would be helpful? That depends on which side of the coin you’re on:
- If you have concerns about OTCs, share them clearly and succinctly — ideally offering specifics about their potential impacts on patients and the profession.
- If you’re cautiously optimistic but see opportunities to further refine the regulations in the interest of patient-oriented care, share those suggestions, too.
The FDA has three years from the law’s summer 2017 enactment to issue its guidance, and the six-month comment period will likely follow that. So look for the federal agency to release the draft regulations along with commenting instructions — likely online — sometime between now and August 2020. Once comments are reviewed, the guidance either goes into effect or changes based on feedback.
Consider the Potential Windfall
If you see this disruption in our industry as a change that could help millions of people who’ve done nothing about amplification until now, that’s a positive. Making hearing care top of mind for people who hadn’t even considered it could mean a windfall for entrepreneurial hearing care experts ready to serve.
OTCs will invariably actuate some consumers who suspect a mild to moderate hearing problem. They will also enable many people to purchase devices they can afford and are willing to wear. And if these instruments do help them hear, that’s a win for the mission of our esteemed profession.
Maximize the Opportunity
Though much remains to be worked out — How will the FDA classify the products? What safety labeling will they have? Will the packaging advise consumers to seek an audiologist’s assistance? What will the manufacturing requirements be? — it’s important to consider whether and how you’re going to capture this new market in your practice, because people will need help.
Here are ways to maximize this opportunity for the benefit of your business and those you serve:
Offer OTCs In-House
FDA-regulated hearing aids will be available at area drugstores, so why not get in on the action? A strictly retail model in which someone could simply come in, buy an OTC without seeing anyone, and leave can help you fill a burgeoning niche. You’re still providing a service — giving consumers the ability to take action on their potential hearing loss. They may find after trying the device at home that it’s not their cup of tea, in which case they can return to seek professional help from you.
To demonstrate the OTCs, you could have a dedicated room with a TV and a loop system — or your waiting room may already be outfitted with these resources. The consumer can sit there for a few minutes, try the devices, and see what they think. It’s a service and flow opportunity easily accomplished without spending a lot of money helping potential patients test the OTC waters.
Create a Service Package
The consumer may buy the device, open it at home, and think, “I have no idea what to do with this. Where does it go? How does it work? What are domes, and which size do I need? How do I insert this device? Where does the battery go?” They’re going to need expert assistance — just as folks would for a traditional hearing aid. Whether an orientation, a fitting, or related help, these services can be provided, coded, and billed for OTC hearing aids. In addition, at least one major insurer has already stated it will cover mild to moderate OTC devices.
With the pending OTCs aimed at self-perceived mild to moderate hearing loss, it’s sort of a shot in the dark if the patient doesn’t know what’s considered in that range. They could have a more severe hearing loss than realized. Do they need a hearing test for greater accuracy? Do they want follow-up care? Now’s the time to consider how you’d want to provide and bill for such services.
I would encourage the testing be done before anything starts, so the patient’s expectations can be managed — and there’s a code for that. If you and the patient find that the OTC device is appropriate for the type of hearing loss at hand — and they want to move forward, including getting your help with the mechanics of it all — then you can proceed accordingly if they choose to engage a provider.
Leveraging OTC hearing devices requires a sense of perspective. Many consider them to be the “cheater glasses” of the audiology industry. Cheaters, however, haven’t hurt the optometry business at all. Some are also concerned that OTCs will devalue the profession. Instead, they can add value by helping you:
- Assist people who may otherwise not have taken action
- Create a relationship for other hearing aids that may be in the patient’s future
Will the new category of hearing devices deter certain consumers from perhaps purchasing a more appropriate device if they have more hearing loss than they suspect? It’s possible, but overall this industry evolution can mean better opportunities for consumers and providers. If you incorporate OTCs, a new category of patients will potentially come in, and now they’re loyal to your practice and will return for additional help along their better-hearing journey.