The U.S. Food and Drug Administration’s draft guidelines for over-the-counter hearing devices are expected in early 2022. But this harbinger of an industry sea change needn’t be cause for alarm. In fact, as an independent hearing care practice, you’re in a unique position to lay out a strategy that capably navigates the coming OTC disruption.
How We Got Here
The President’s Council of Advisors on Science and Technology and the National Academies of Science, Engineering, and Medicine independently released reports indicating that prevalence of hearing loss in the U.S. is high but treatment prevalence is low. They asserted the causes included:
- Cost-prohibitive pricing
- A service-delivery model that doesn’t allow for timely product acquisition
Each group recommended the FDA implement a new device category for over-the-counter wearable hearing devices for self-perceived mild to moderate hearing loss. Soon after, the bipartisan FDA Reauthorization Act of 2017 was passed, and the agency was tasked with making this recommendation a reality.
What You Can Do
When the FDA releases the guidelines, they will be an open public draft. The guidelines will cover everything from service delivery and consumer safety to electroacoustic measurements. Read the document, and send the FDA your feedback. OTCs can’t be stopped — that ship has sailed — but you can offer your helpful feedback as a hearing care professional.
Review the guidelines from the perspective of your patients’ safety and your medical integrity. Think about the electroacoustics. These devices will end up in the hands of patients, who will effectively be self-fitting their hearing aids. Weighing in from that viewpoint may help shape an even more measured, informed, and deliberate set of regulations.
Once FDA officials have considered and incorporated feedback, the updated guidelines will be released, at which point the agency will start testing and approving devices. This is also the point where you can get a firsthand look at the devices to understand their strengths and limitations, should someone come in with one and seek out your help.
What the Model Might Be
The General Case
We can’t know for sure what the model will be, but we do have indications of what a general protocol might look like. The user will either take an online hearing assessment, or the OTC hearing aid will, in effect, conduct a hearing assessment in the user’s ear. In either case, a profile of the person’s listening ability will be generated, which can then be turned into a prescriptive formula for them to follow.
As for custom products, one model is already in place in the world of personal sound amplification products. PSAPs — which aren’t FDA-regulated — are for those with normal hearing who want to accentuate certain environmental sounds, as during bird-watching, for example.
At least one PSAP currently on the market operates much like a hearing aid, and the consumer’s programming capabilities present much like an audiologist’s. When the customer takes an online test, the results are reviewed by the PSAP company’s in-house audiologist. If the results warrant, they might recommend the customer pursue a custom device from someone the company contracts with.
Most audiology practices bill only for time. What we have forgotten is that those in other professions — such as some in the legal community and folks in other medical fields — charge for both time and complexity. What would that look like for hearing care?
Let’s classify the PSAPs presently on the market as class 1, class 2, and class 3, where the first class is the easiest. When someone comes into your practice with a PSAP, you charge a time value and, if applicable, a complexity value. The more parameters, the greater the skill set needed to fit the device —hence the appropriately greater cost for classes 2 and 3.
Some states don’t allow audiology assistants. In those states that do, assistants may be prohibited from handling OTCs and PSAPs. If they are allowed to handle such products, you could add schedule blocks for those staff members to help users of class 1 or 2 devices, freeing you to work only on devices of greater complexity. You’d still check in with each patient to build rapport and review the assistant’s work.
How OTCs Will Impact the Market
Different Needs for Different People
The hearing-device market is like any other, so we will see an impact. Every market includes a product or service for individuals who want a quick and inexpensive option they can obtain on their own. But there’s also a category of service that comes at a more premium price for those willing to invest — because they know it will improve their quality of life.
When brakes on a car start making odd noises, for instance, a consumer might take the DIY repair route. Many, however, haven’t the time, inclination, or know-how to tackle such a task. Most would likely prefer to pay an expert who’s going to provide quality service, ensure the brake pads are installed safely, and stand by their work.
That’s exactly where many of our independent practitioners are in the market. It’s a matter of conveying to prospects that the hearing aid itself is not going to be the silver bullet. Rather, it’s the expertise in programming that device, it’s delivering a quality patient experience, and it’s engaging with the patient to ensure they’re successful on the journey to better hearing.
Patient Loyalty Starts Now
As mentioned, we will see an impact: Some individuals who might otherwise pursue a traditional device are going to go down the OTC path. To what extent is merely a guess at this stage. It’s a reasonable bet, however, that adding some schedule blocks devoted to services for OTC and PSAP customers may expand your revenue stream.
You might even start now — with PSAP wearers. Though intended for people with normal hearing, PSAPs are also being worn by those with hearing loss. Serving this audience allows you to capture some of that revenue. It also provides an opportunity to show a new client base the benefit of quality care and service.
If you’re an Audigy member, stay tuned. We’ll be closely reviewing the draft FDA regulations once they’re out and offering recommendations on best practices. With OTCs slated to be one of the biggest disruptors in today’s industry, preparation will be key.
Do you need support reaching your practice’s goals in a changing market? You deserve a partner that helps you stay ahead of the curve and thrive. You deserve the best.