For the past 5 years, the US Food and Drug Administration (FDA) has not required patients to sign physician waivers prior to being tested and fitted for hearing aids. The ruling remains a positive for the industry, but it’s also true that those “red flags” that motivated the waivers in the first place did not go away.

A hearing evaluation from a licensed dispensing professional is a much safer route than buying an online hearing device that doesn’t include a look at the “whole person,” and indeed almost all states still require professionals to screen for the red flags—even if the FDA does not require it. While no one wants to scare consumers about hearing loss, including red flags on the practice website and reminding consumers that hearing loss is a chronic medical condition that affects physical and mental health, it is certainly warranted.

Daniel Ostergren, AuD

With that in mind, Hearing Review sat down with Daniel Ostergren, AuD, Audiology Group of Northern Colorado, Fort Collins, Colo, to get an idea of the impact of the FDA’s declaration five years ago. Dr Ostergren—a third-generation medical professional—believes the FDA made the right decision, and he chooses to emphasize “comprehensive care” to make sure he sees the full patient picture. If hearing loss turns out to be a symptom of a major health problem, he quickly refers the patient to a physician.

Hearing Review: How do you view the FDA’s declaration roughly 5 years ago?

Ostergren: It’s great that patients have direct access, but any change affects a lot of other variables. It’s one thing for audiologists to be checking for red flags, but you must have a multi-tiered approach. Everybody needs to be aware of reporting changes if something doesn’t feel right. We need more hands on deck than just the audiologist.

Hearing Review: How do you define comprehensive hearing care?

Ostergren: We start from an assumption that hearing care is healthcare. When you’re dealing with hearing devices and technology, you’re also in a consumer model. Our practice chooses hearing healthcare, meaning we don’t just sell hearing aids. It’s health care. It does involve a lot of case history work, and that may not appear directly related to hearing. Our report goes to physicians and demonstrates that we are teaming with colleagues to advocate for this individual’s healthcare. Those practices that are more of a commodity model may not do that as aggressively.

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Hearing Review: What are some red flags for other sicknesses/ailments?

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Ostergren: First, there may be variations in gait. How is somebody walking? I used to tell my grad students that the hearing evaluation starts before the person gets in the room. If I look down the hall and see a patient coming, I start to get some first impressions. Gait is an easy one. Posture, speech patterns, little things. How is the person standing, walking, and talking? Most of us know when something feels off with gait, posture, and speech. In our practice, we know most of our folks pretty well over time, and we can see changes happening. 

Hearing Review: Can you share a specific example?

Ostergren: We had an adult male and I watched him checking out. In his wallet he had written cards that had phrases on them. The phrases were things like “University of Texas” and that was where he had worked. He had started realizing he was sort of forgetting things, so he had written them down. His wallet was thick with stuff like that, and it wasn’t when he’d visited in the past. His wife came in on a separate day, and I asked how he was doing. She said she was not sure. I told her what I noticed. This was only 18 months ago, and now he doesn’t know who she is and is in assisted care. 

When I was in pediatrics, I had a child who had multiple disabilities and was non-verbal. His hearing with conditioned play was reliable, and I knew what his aided results should be. He came in and something wasn’t right. He looked great, but I could not get the results I expected. The hearing aids were great. I checked tympanometry and other health concerns. He had nothing. After many other tests, I referred him to an ENT doc, and about 10 days later I got a call from the physician. He said, “You need to know that this kid had a pretty significant brainstem tumor, and they were able to get a good bit, but not all of it.” He was saying “good call.” So, it’s that small voice inside of you that says something isn’t right, and we have to figure it out. If you over-refer, what’s the problem? Obviously, you don’t want to load the system, but don’t hesitate. If you think something is not right, you probably should pursue it.

Hearing Review: How do financing options fit into your view of comprehensive care?

Ostergren: I want to be in partnership with patients who are in charge of their hearing health care. I don’t want a third party involved. As a result, we went to 100% direct pay. That’s great but not everybody has that kind of cash. To help with that, we offer financing.

More than half of our patients in 2020 leased their hearing aids. As I see patients moving toward the end of their lease, I may discuss financing options with them, which could include a low interest or no-interest loan. I like people to know what’s out there. The main thing is for patients to know and value their hearing. When it’s important to them, they will partner with you.

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.