The Over-the-Counter (OTC) Hearing Aid Act of 2017 requires the FDA to propose regulations to better govern OTC hearing aids for the treatment of adults with mild-to-moderate hearing impairment. The FDA missed its August 2020 deadline citing competing priorities during the COVID-19 pandemic. 

Stacy O’Brien, AuD

Stacy O’Brien, AuD, at Florida-based Atlantic Hearing Balance and Tinnitus Center has closely followed the OTC saga from her office in the Sunshine State. Instead of trying to anticipate the likely effects of the regulations, O’Brien chooses to emphasize patient care. It’s a strategy that she believes will serve all audiologists well regardless of how the regulations turn out.

Hearing Review sat down with O’Brien to learn more about the philosophy and to get an idea of how she views optimum patient care.

Hearing Review: How has the flow of patients been in recent months?

O’Brien: We’re busier than ever…There are a lot of open, shut, and open-again retail stores that work on commission only. They use no best practices. We revamped our patient pathway during a bit of the downtime in the second quarter 2020 and thankfully came out really strong.

Hearing Review: What is your prediction about OTC regulations related to the 2017 legislation that may be coming?

O’Brien: There have been [hearing care-related] items you can buy in Walmart and Walgreens for a long time. There is competition online. I receive so many emails from people asking me, “Is this good?” So the commoditization of hearing healthcare and hearing aids has always been there. I truly believe if we focus on the patient and patient care, it’s not going to be a problem.

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Hearing Review: How should audiologists be positioning themselves?

O’Brien: If you can diversify and help the whole ear, that’s going to help make you more of an asset to your community. For example, with tinnitus, you can get all the information, knowledge, and special certifications. Any kind of extra training that you can get, you can help more patients. Learn the balance [vestibular] side of it. We treat those patients as well. There’s wax removal, itchy ears—not just focusing on hearing aids. If you’re worried about the commoditization and OTC coming about, and yet all you “do” is hearing aids, then that might be a little more concerning. In our locations, we support the entire ear. 

Hearing Review: How do you deal with the perception that your non-OTC products are overly expensive?

O’Brien: Financing and money is unfortunately a big roadblock. It’s a difficult part of what we do. It’s probably the worst part about what we do. Money concerns will hold patients back from treatment. It will actually pull patients back from even coming in to get diagnostically tested. That’s a travesty, because they feel like they need something, but they don’t want to be talked into buying anything since they’ve heard nightmare stories of how they’re too expensive, don’t work, or end up in a drawer.

Hearing Review: And how do you respond to those concerns?

O’Brien: It goes back to patient care. When you follow best practices, that perception doesn’t occur. Financing is part of it. In our practice, we make sure that when a patient is ready to treat, that there are no financial roadblocks. The financing part of it is such a blessing. We have a lot of patients who use financing, and that is the only way that they can get the help that they need. I think it’s just a part of being patient-centered to have different [low-interest and no-interest] options.

I’m really passionate about making sure we have a way to help patients who can’t afford it. We started a foundation where we can give patients hearing care and devices if they qualify financially. I’m passionate about finding a way for every patient either through the foundation or financing.

Hearing Review: What are the problems that patients experience with OTC products?

O’Brien: The usual issue is that it’s amplifying everything. They only wear it in their own home for television, for example, and they’re not educated on how we hear. We hear at the level of the brain. It’s not just about putting something in the ear. We actually will recommend a Pocketalker or something like that to a family if a patient cannot adapt. If a patient comes into our office and has an OTC, typically they’re coming in because the OTC has not worked.

Usually, our patients are older with presbycusis, age-related hearing loss, noise exposure, and they’ve got the high frequency sloping loss. They report [the OTC device] amplifies everything and it’s not helping with understanding. Understanding comes from most of the higher frequencies. That’s where a lot of the important consonants are—the beginnings and endings of words—[whereas] they have better low frequency hearing. When they put these amplifiers in and they turn them up, they can’t get them loud enough to give them the understanding they need without blowing out, volume wise, the lower pitches. So, ultimately, we do a lot of education.

About the author: Greg Thompson is a freelance writer and a former editor of Physical Therapy Products and other publications. He is based in Loveland, Colo.