The Hearing Journal (HJ): The story of the year is that OTC hearing aids have officially become the law of the land. What do you and your members think about this significant change?
DiSarno: Some members are embracing this as a good thing, and others are looking at it more cautiously. A lot is going to depend on the quality of the devices and the ability of the consumer/patient to self-diagnose and choose a device on his or her own. It will be interesting to see as hearing aid companies sort of dip their toes in the OTC market. But as an organization, ASHA continues to strongly hold that because hearing loss is a medical condition that may be the result of an underlying illness or disease, the purchase of a device that is designed to address hearing loss should only be done after an audiological evaluation by a licensed and certified audiologist.
Windmill: In our membership, there's a real diversity of opinions, and a lot of that depends on where they are in their practice and their careers and how much their practice depends on amplification products as a part of their economic models. But there are still many people who are really unsure about what the impact will be. Nobody's giving them any real guidance, and of course, there's not much guidance to give at this point because we don't know when they're coming out, what they're going to look like, and how much they're going to cost. Until that happens, it's hard to give guidance.
In terms of impact, there are several other factors to consider. On a practical level, it's very easy to surmise the impact of OTCs on current dispensing practices. But if one reads investment reports from companies that closely examine our market, they're seeing a minimal impact on practices, if for no other reason than the aging population is expanding rapidly. They see expansion of the baby boomer market as offsetting any losses within audiology practices.
Morris: I think that OTCs could help many people if they are marketed the right way. Every audiologist should implement these options in their practice because I do feel like that the audiologists will play an integral part in the success of OTCs. In my previous practice, I had many patients who left my office wanting help, but I could not provide them with an option that was in their price range. This made me and the patients frustrated, and worse, this compelled the patients to figure something out on their own. If I could have provided them with a helpful solution that was within their budget (which I could monitor because they would get this from my office), we would've all been happy.
DiSarno: Another important factor that we all recognize as important but don't hear a lot about in the new OTC model is this: Does the FDA have plans of measuring the outcomes of the model? Is there going to be an 800 number for people to call when they are satisfied or dissatisfied? There needs to be a way to measure consumer satisfaction and outcomes that is built into the system. We'd love for the FDA to do some trial prior to having these devices out in the market.
Morris: Audiologists need to be a part of the conversation on what labeling/warnings and standards need to be put in place—and that is where we can make the greatest impact on the new law. Among audiologists, I believe the biggest hurdles include accepting change and having the willingness to think outside of the box to do what is best for patients.
HJ: So are you saying that OTCs may open up new markets and not directly compete against the traditional hearing aid industry?
Windmill: OTCs will tie into a new market, but I think the hearing aid market will naturally be expanding anyway and will offset any losses that we may feel with the OTC devices. With the baby boomer population now aging, the investment houses are predicting a growth in the hearing aid market of five to six percent year over year over the next five to six years, so it will just offset any potential losses from OTC devices. However, there likely will be downward pressure on the pricing structure of traditional amplification devices, including a greater necessity to provide pricing transparency. We are already seeing practices beginning the process of unbundling or itemizing their charges for amplification, but any pressure to lower prices may not occur until OTCs become a reality.
DiSarno: As mentioned, the number of individuals who need amplification is going to grow; however, the number of individuals who will need amplification and additional services will grow as well. Some consumers may be able to utilize these devices to a considerable degree of success, but we also know that there's a very large number of individuals whose hearing impairment has impacted more than just their ability to follow a conversation. There are also possible comorbidities, and the device alone will not satisfy these needs. So I don't see this as producing a significant impact on patient populations that will frequent audiology offices. I think it will have a small impact, and it may actually benefit a small number of individuals as an entry point—sort of testing the waters on what a small boost in amplification can do—and for those individuals who just need that. One thing we can assist our members with is to help them educate consumers about what the practice of audiology does and the rehab services that it can provide, noting that it isn't just about a device.
Windmill: Educating consumers and giving our members the tools to educate consumers are important components of what the organizations are trying to do. Another area that is also a challenge for us as an organization is to recognize that our responsibilities as audiologists are to manage hearing, communication difficulties, and other problems that people present with. We tend to think in fairly narrow terms of hearing loss with hearing aids. So another challenge that we have is also educating our members that they can utilize these new technologies in different ways. There may be certain state or local requirements in terms of taxes or advertising, but it's no different from dermatologists selling skin care products or dentists selling whitening products. The opportunity for audiologists to provide OTCs and PSAPs is there. In certain cases, it may be much better for patients to get their OTC product from an audiologist because they can couple it with other treatment options, have better settings and compliance, and get better outcomes.
Another challenge that we have as associations is helping members of licensing boards understand the boundaries between OTC and regulated devices. Part of the support is for organizations to work with licensing boards and related regulatory agencies so compliance guidelines are developed in response to OTC.
DiSarno: Some audiologists may be hesitant to work with patients who show up with a device that they did not provide. That is a challenge, but it can be overcome if audiologists realize what their purpose is: to work with people with hearing difficulties. Audiologists need to modify the way they practice, so they can provide services to a wide range of patients.
HJ: But how do you charge counseling services, for example, when a patient comes in with an OTC device? What's the new business model?
DiSarno: Audiologists can modify the way they do business by utilizing the services of assistants. To run their practices more efficiently, they do not have to be the ones to provide every single service to every single patient. Audiologists can see more patients and possibly make up for some of the difference that they would've seen by providing high-end instruments to each patient.
Windmill: We also have to consider alternative business models when considering the economics of hearing care. For example, patients are used to paying co-pays for office visits, but this is not something we have taken advantage of in audiology, particularly for the post-fitting follow-up visits. Patients could be charged with an office visit fee that is comparable with a co-pay. You're collecting a different fee under a different structure, but which can be beneficial to your bottom line in the long term. Sometimes it's not about just unbundling or itemizing the current pricing structure—it's a matter of doing business differently.
DiSarno: Also, we can get insurers to fully understand that hearing loss is a medical condition and that patients require assistance in paying for medical services. Third-party insurance and Medicare need to assist patients in the cost of hearing health care service. As associations, we need to continue to advocate for reimbursement for services.
Morris: A speaker at ADA's recent conference shared a related business model that she implemented several years ago as she saw the writing on the wall of what was to come. She runs an “OTC store,” which is a separate business from her audiology practice but located in front of it. She offers a wide range of products, and her retail store staff are trained and aware of the signs when consumers may need a referral to the audiology practice. The combination of products and services through this separate entity alongside the audiology practice has been very successful. We owe it to our patients to provide them with all alternatives that best fit their needs, and this model is a great way to offer this.
HJ: We've also seen research and technological advances in 2017. Which breakthrough or emerging trend has particularly caught your eyes and why?
Windmill: We're seeing a lot of initiatives to develop preventative systems, pharmacologic-based gene therapies, and hair-cell regeneration—these are the next level of possibilities. I do not see cures for hearing loss, but I see other treatment options that we can consider and understand. I also see a greater ability to measure the true types of problems that individuals have. Our ability to assess individuals continues to expand in different ways, such as in cognitive decline where we can measure the status and the treatment outcomes. These are in addition to the ongoing technological evolution.
DiSarno: Many of these exciting breakthroughs deal with prevention, and audiology is as much about prevention as it is about treatment.
Morris: And we will see much more creative and practical uses for hearing technology in the coming years.That is exciting to me. With more tech-savvy companies coming into the hearing market, I think this will be a win-win for patients and audiologists. It will allow more competition from more firms, and it's anticipated to lower the cost of hearing aids for millions of Americans. Again, if audiologists utilize this in their practice, along with their expert services, they will gain loyal patients, and patients will be assured with the best possible care.
HJ: Finally, in light of these emerging trends and regulatory changes, what is the greatest opportunity for audiologists as we head into 2018 and beyond?
Windmill: An important opportunity is a shift from considering hearing loss as an ear-related phenomenon to audition and communication that includes a greater understanding of ear and brain function. Twenty years ago, we had the “decade of the brain.” For audiology in the next decade, I think we're going to see the emergence of the role of the audiologist in managing not just ear dysfunction but also the associated brain function. This will involve pharmacology, aging factors, children with development issues that have an auditory component, and other areas as we understand more about the relationship between hearing and the brain.
DiSarno: What's becoming more evident is the importance of communication in patient treatment. The need has always been there, but I don't think the effort to get audiologists involved has been as important as it is now. The audiologist's role in patient-centered care needs to be tapped and utilized more.
Morris: The greatest opportunity for audiologists is to become the profession it was meant to be. We have this opportunity because, like it or not, the OTC legislation has put audiologists on the radar. More people know who we are and what we do in Washington, DC—and that is big. We have the opportunity to get behind the Audiology Patient Choice Act, which allows Medicare Part B patients to go directly to audiologists for the care they need and for audiologists to be reimbursed for Medicare-covered services that they are state-licensed to provide. This bill also includes audiologists in the list of Medicare-recognized limited-license physicians (i.e., optometrists, dentists) to help meet the need of the growing Medicare population. Finally, it aims to address the shortage of medical doctors by giving audiologists the autonomy to make clinical recommendations and practice at a full scope, as allowed by their states and prescribed by educational institutions.
Windmill: Part of our challenge is to consider how we can adapt today to a future that will include people who think differently—those who do not access our services today but will do so in the future. So a challenge for professional organizations and individual practices is to begin to anticipate what's going to happen and how to take advantage of service delivery options that might improve satisfaction, decrease cost, and enhance the economic viability of audiology practices.
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