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Special Report Part 2 — Consensus Among Industry Leaders on OTC: Audiologists Play Critical Role in Patient Satisfaction

doi: 10.1097/
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Editor's note: This article is the second in a special three-part series on the over-the-counter hearing devices guidelines and initiative. Part 1 provided perspectives from hearing health care professionals (June issue;; the series conclusion, to appear in the August issue, will present consumers’ perspectives.


The approval of the Over-the-Counter (OTC) Hearing Aid Act in 2017 ushered in the creation of a new OTC hearing aid category that, pending the guidelines to be developed by the Food and Drug Administration (FDA) by 2020, is anticipated to disrupt the playing field. For people with mild to moderate hearing loss, these OTC devices open a door to accessible and affordable hearing care. For hearing care professionals (HCPs), these open a door of opportunities that require meaningful and strategic preparation—as noted by the audiologists in our June issue roundtable. Where does this door lead for manufacturers of prescription hearing aids and for other key players in the hearing aid industry? These industry leaders confront this question as they gear up to navigate a future with OTCs: Aaron C. Jones, AuD, the director of Unitron's In-clinic Success; Steen Frentz Laursen, the vice president of group communications at GN Store Nord A/S; Steve Mahon, CEO and president of Sivantos U.S.; Gary Rosenblum, the president of Oticon, Inc.; Mary Anne Stangby, the senior vice president of Elite Hearing Network (part of Amplifon); and Misty Stern, the executive vice president of operations and marketing at Audigy.

From your company's standpoint, what is the role of audiologists in today's OTC hearing device movement? Can audiologists be excluded from OTC hearing aid dispensing all together?

Jones: The role of independent audiologists in today's OTC hearing device movement includes conducting hearing tests and providing access to low-cost amplification when appropriate. At Unitron, we believe hearing instruments and audiological services should be itemized in an unbundled model whenever possible. Details of the OTC Hearing Aid Act allow for the exclusion of audiologists from hearing aid dispensing because those devices may include features for self-assessment and self-adjustment. However, experience tells us that independent audiologists are likely to remain a critical part of the process. It is necessary for independent audiologists to make the value of their professional services clear by itemizing so consumers seek their care despite the availability of OTC hearing devices.

Laursen: Hearing loss is a medical condition that most often requires professional care. Historically, hearing aids without accompanying counseling and support have proven to be an unsatisfactory solution for the user.

Mahon: It all comes down to patient satisfaction. One study found that 61 percent of patients who wear hearing aids fitted by an HCP were satisfied with the results, while only 28 percent of those with OTC devices (and didn't consult an HCP) were satisfied. If more people are satisfied with their hearing aids, they're more likely to wear them and benefit from them.

Overall, we believe in the protocols that maximize patient outcomes, and it's clear that HCPs are essential to delivering successful results. So, can patients get hearing devices without an HCP? Yes. Should they? Well, the research suggests they're more likely to be dissatisfied without the guidance of an HCP.

Rosenblum: We believe that “Hearing Care is Health Care™.” The hearing health care (medical) model is the reason that patient satisfaction in the United States is above 80 percent. Audiologists and hearing instrument specialists are our partners who deliver medical solutions that address medical problems with medical devices, regardless of any movement now or in the future. The FDA's definition of OTC medical devices states these products can be acquired without the involvement of health care professionals, so of course audiologists will likely be excluded from some OTC hearing aid dispensing. However, we sincerely hope that audiologists and hearing instrument specialists will continue to play the important role of the hearing care expert and, based on the specific needs of the patient visiting their clinic, determine the appropriate device and settings needed. We will also continue to work with HCPs to help and encourage them to establish their vital role in the process.

Stangby: Our business model integrates scientific know-how, innovative technologies, and the human touch and expertise of HCPs to deliver a bespoke and personalized experience to every patient. Today, audiologists serve the majority (~65%) of individuals with disabling hearing loss. These individuals are highly satisfied with their device (83%) and their professional service (95%). For them, audiologists will continue to be the reference point in their hearing care journey.

However, only 10 percent of individuals with mild hearing loss has hearing aids. OTC devices aim to encourage this patient population to access hearing care earlier. While hearing solutions are already advertised and available online, this has not dramatically improved adoption. Stigma and attitude toward hearing aids remain key drivers for non-adoption. Only education and thoughtful guidance can change this perception. If OTC devices will encourage individuals with mild hearing losses to start their journey earlier, this presents an opportunity for audiologists.

Stern: We see the audiologist as the expert in comprehensive hearing health care. Furthermore, we see their role becoming even more important. As technology options become more varied and the decision-making process becomes more complex, our local communities will continue to seek answers to their most pressing questions, such as:

  • What can I learn from others’ experiences?
  • What does my primary care physician recommend?
  • What will work best for me in my everyday life?
  • How do I receive the most value for my investment in hearing care?
  • What should my family and I expect from my investment in hearing care and/or technology?

The audiologist has an opportunity to provide these answers through hands-on, high-value, personalized care and community awareness. A space that already feels cluttered will become even more saturated with new technology disruptors, and we have a responsibility to ensure that prospective and existing patients as well as physicians have the information they need to experience better hearing.

To ensure individuals receive optimal hearing assessment and treatment, how will you relay the message to consumers that audiology services should be a part of their overall hearing care?

Jones: We wholeheartedly believe in providing an exceptional end-to-end consumer experience, of which audiology services are a crucial part. We have a suite of technologies and programs designed to make the process of buying and using a hearing instrument feel easy and empowering that focuses on counseling, evidence-based technology recommendations and aftercare, all delivered with the assistance and expertise of an audiologist. Unitron offers audiologists marketing support and materials that relay this message to consumers.

Laursen: Again, hearing loss is a medical condition that requires the right care, and this needs to be addressed with the new OTC hearing aid dispensing.

Mahon: We've made a significant investment in lead generation through our partnerships with HearUSA,, and TruHearing, bridging the gap between consumers and the HCPs who can help them hear. Through our consumer-facing materials, we stress the importance of regular hearing tests and visits to an HCP for evaluation, diagnosis, and treatment. Also, with our HCP locator tool prominent on our website, we don't just talk about the importance of seeing an HCP; we actively encourage and make it easy for those who may have hearing loss to see a qualified professional for proper treatment.

Stangby: We strongly believe that HCPs and their services are a key component of a superior patient experience. Consumer education about hearing loss and the most appropriate hearing care solutions has been one of our company's priorities for years. Any educational effort in this area should inform the consumer about when it is recommended to seek professional advice. Campaigns to raise awareness of the importance of timely and appropriate hearing care are needed now and more so in the future. Finally, as a company, we also recognize the importance of prevention, and strongly support campaigns aimed at increasing awareness of noise-induced hearing loss and how to prevent it. For example, we support “Make Listening Safe,” an initiative launched by the World Health Organization (WHO) to “ensure that people of all ages can enjoy listening with full protection of their hearing.”

Stern: Audigy members have been focused on building their independent brands based on the value a hearing care team brings to the patient as opposed to the value that technology alone can provide when used without comprehensive fitting and follow-up support. Our members have access to a private brand that is focused on the role of the HCP in the diagnosis and treatment of hearing loss, versus focusing on technology alone as the solution. Technology is a key part of the equation; however, surveys have shown that the relationship between the provider and the patient is key to satisfaction and positive outcomes. These facts need to be covered in an integrated marketing approach that lean heavily into digital. From online reviews to YouTube videos to blog posts preemptively answering the most common questions people have about hearing loss and OTC hearing devices, those who invest in developing useful content will be well-positioned as the experts in our field. Audigy employs 40 marketing professionals who are entirely focused on building our members’ brands in their local markets. We'll continue to invest in these areas to ensure our members’ value proposition is based on personal connections and individual patient results versus products.

Rosenblum: Our company has a long history of proactively supporting the hearing health care (medical) model in our general communications and patient education materials. We have a great product, but the outstanding satisfaction patients achieve is directly related to the expertise of the hearing care practitioners who fit our products. Oticon maintains that the very best pathway to success for a person with hearing loss is to acquire excellent products, facilitated via a licensed HCP. We design our products with hearing care professionals in mind, as expertly-fit hearing aids allow users to access the full potential of hearing technology. We regularly communicate this in our advertising to consumers and in our messaging to our hearing care professional partners who treat patients every day.

How has the entry of OTC hearing devices affected your business model?

Jones: The entry of OTC hearing devices has led Unitron to accelerate its development of the FLEX ecosystem and the related business model. The FLEX ecosystem will continue to include tools that empower audiologists to highlight their expertise and tools that make running a hearing health care practice easier. In addition, we'll continue supporting audiology practices in ways that improve patient experience. By providing consultation on pricing, marketing, and change management, we are helping independent audiologists succeed in the rapidly changing competitive environment.

Laursen: This is too early to say, as it is still unclear how the FDA will regulate this area.

Mahon: While we're aware of the potential changes to the industry, since OTC hearing devices have yet to become available, it's still an open question as to how it will affect our business model. However, their entry and potential expansion will likely encourage more people to seek solutions for their hearing loss. We'll have to wait and see the regulatory recommendations for fitting such devices, but as research suggests, having an HCP involved in the process is crucial to long-term patient satisfaction.

Rosenblum: OTC hearing devices have not affected our business model at all. Oticon focuses on developing premium technology that delivers unprecedented patient success and satisfaction based on the expertise of hearing health care professionals. Oticon has no plans to sell an OTC product in the United States. Entering the OTC market is inconsistent with our vision of the best path forward for people with hearing loss. Our intention is to continue to support HCPs and the professional hearing health care pathway.

We know that our success is dependent on our ability to support the independent hearing care professional, not only with premium technology but also with the audiology and marketing support they need to reach and fit more patients. We are committed to promoting the importance of professional hearing care, and we reinforce that commitment by supplying our hearing solutions only to providers who fit and sell Oticon products to patients through face-to-face consultation, evaluation, and fitting.

Stangby: The FDA has two years to publish the final rule. The business implications of OTC devices will vary depending on the specific provisions included in this final regulation.

The OTC market could represent a positive innovation for consumers and audiologists alike if individuals with mild-to-moderate hearing loss will engage in our member practices earlier in their hearing health journey. OTC devices can also present an opportunity only if it allows for the balance of availability and affordability with safety and effectiveness. If these devices fail to promote such balance, they may be detrimental to both consumers and audiologists, as demonstrated by international experiences with OTC models that show low consumer satisfaction and adoption rates. We will support our member practices to understand the final FDA guidelines and evaluate their business implications.

Stern: As our industry continues to evolve, more practice owners, providers, and teams are looking for strategic guidance and opportunities to be part of a community of like-minded professionals with a shared vision of what's possible for the future of our profession. We've been building upon a solid foundation of collaboration with some of the industry's leading professionals since 2004. We will continue to utilize data to establish best practices around patient care, teamwork, and practice operations. We wholeheartedly believe in the work of our members, and their ability to help more people get a better quality of life inspires us every day.

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