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Special Report: Part 1 Audiologists Get Real on Impact of OTC Devices

doi: 10.1097/01.HJ.0000538925.50302.88
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Editor's note: This article is the first in a special three-part series on the over-the-counter hearing devices guidelines and initiative. Presented in a roundtable, Q&A format, the series provides perspectives from hearing health care professionals, industry leaders (July issue), and consumers (August issue). Each article is accompanied by a podcast found on the “Videos & Podcast” tab at for additional commentary.

hearing aids, audiologists

After the approval of the Over-the-Counter (OTC) Hearing Aid Act in August 2017, an inevitable question hovered over audiologists across the United States: What's next? The bill, which called for the creation of an OTC hearing aid category for people with mild to moderate hearing loss, also required the Food and Drug Administration (FDA) to develop regulations on the technical specifications and labeling of OTC hearing aids (ASHA Leader. 2017;22(10):10). The FDA has three years since the bill's approval to propose a set of guidelines, invite public comments, then publish the final rules in the Federal Register.

And when it comes to the impact that OTC hearing devices may or may not have on audiology practices and hearing care, audiologists have a range of opinions, as evidenced by the views expressed to The Hearing Journal by the following individuals: Kim Cavitt, AuD, an adjunct lecturer and clinical placement coordinator at Northwestern University; Gyl Kasewurm, AuD, a practice owner based in Saint Joseph, MI; Nicholas S. Reed, AuD, an instructor of audiology at the Johns Hopkins School of Medicine in Baltimore, MD; and Christine Throm, AuD, a practice owner in Los Gatos, CA.

As the FDA develops guidelines for OTC hearing devices and the American Academy of Audiology publishes their own audiologist's guide, what, if anything, should audiologists be doing to prepare?

Cavitt: Audiologists should consistently provide evidence-based care and offer diagnostic and rehabilitative services not available over the counter or online. They should have pricing structures that accommodate patients who want to begin their communication journey on their terms, not ours, and structures with itemized aspects of care. Audiologists should have hearing aid delivery models that include disruptive technologies like OTC devices, personal sound amplification products (PSAPs), and assistive listening devices, and options in terms of how long-term hearing aid follow-up is delivered and valued.

Kasewurm: The study by Humes, et. al, supported the efficacy of using best practices to fit hearing aids (Am J Audiol. 2017 Mar 1;26(1):53). As such, it's important that we perform outcome measures and conduct speech-in-noise tests to ensure that outcomes are the best they can be. Pressing the “best fit” button and telling patients to “give it a try” were never good enough for patients, and today, more than ever, we have to make sure we are doing everything we can to provide patients with benefits, including assistive devices and rehabilitation programs. We need to inform consumers that we offer more than just hearing aids; that we are full-service providers for hearing health care services.

Reed: Right now, many people are in a holding pattern as we aren't positive how the FDA guidelines will affect the market. It will be a few years before the market settles even after the guidelines go into effect, so we're in an unnerving time. That said, I think it's time to prepare. Revamping practice models into an unbundled model based on a professional's time sharing his or her skills and service is key to being in a good, flexible position for when the market does begin to really change. It's important that we clarify the services and expertise of audiologists in maximizing patient benefits from PSAPs/OTC devices by separating those services from the sale of a device.

Throm: For too long the emphasis in audiology has been placed on the device. The value of diagnostics and counseling/aural rehabilitation has been undervalued. Our patients don't come to us with demands for a particular hearing aid. They want help with communicating more effectively with their loved ones on a daily basis. The first thing audiologists need to know is their hourly break-even rate. Gone are the days of only offering a bundled package to patients. If you know your worth per hour, then you can charge for your expertise—and it shouldn't matter what hearing aid someone brings through the door. Set up a game plan and know your target market. Do you really want to market to the bottom feeders? Elevate your standard of care.

Do you anticipate an increase in patient load, particularly of individuals who have purchased an OTC device and experienced problems? If so, how do you plan on managing this patient group?

Cavitt: I don't like the term “problems.” Instead, I think amplification awareness will greatly increase, and this may drive consumers to audiology practices for evaluation, fitting and orientation, adjustment or reprogramming, repairs, and upgrades.

Kasewurm: I do anticipate an increased patient load, which is a concern considering the shortage of health care providers. That is why having audiology assistants is essential to handling the increased demand and maintaining business profitability. Hearing health care professionals should spend most of their time diagnosing problems, achieving adequate solutions, and generating revenue. Minor time-consuming tasks that don't require the education and expertise of a professional need to be delegated to support personnel.

Reed: Audiology is likely to see a few waves of increased patient load. First, I think that this segment will begin to come through the practice doors: older adults who are interested in OTC devices but feel that they need guidance before making a purchase. In my opinion, these are people who have previously pursued hearing aid evaluations (i.e., help-seeking) but never actually purchased hearing aids for financial reasons. Second, I think audiology is likely to see an influx of people who have purchased OTC devices and used them for a while but are now looking for a boost and maximized benefits with the help of an audiology professional. Lastly, I think there will be an influx—several years down the road—of older adults who used OTC devices but are ready for the next level. Many from this group wouldn't have normally pursued hearing technology so early, but having accessible devices got them in the door much earlier. Again, the preparation for all these scenarios comes down to ensuring the flexibility of practice models to meet the demand.

Throm: Maybe we will see an initial increase in disgruntled OTC patients, but this should be our opportunity to educate and counsel. To manage this group, we will need to unbundle and charge for our services, second opinion, and expertise. Set up a protocol for real-ear measurements for people with OTCs. Consider doing free demos or trials, not free hearing tests or consultations. Let them experience the difference between the OTC and the “real” hearing aid.

How will you differentiate yourself and your practice from retail stores selling OTC hearing devices to promote the level and value of your services?

Cavitt: Through providing evidence-based services that consumers cannot receive through most OTC entities: comprehensive communication needs assessments, otoscope, cerumen removal, earmold impressions, fitting, orientation, verification, aural rehabilitation, and counseling.

Kasewurm: Our marketing strategy has always focused on providing the best hearing health care, and we have never used price ads. Our branding includes testimonials and reviews to emphasize the quality of our services and the high-level of satisfaction of our patients. Also, we welcome patients who want to be fitted with devices purchased or acquired from other sources for a fee, and we offer service plans to try to connect these patients to our practice. People are living longer and hearing loss is permanent, so we want to convert every patient to a lifetime customer.

Reed: There's no gimmick or simple trick that is going to make audiology stand out. I don't think this is an individual-level question but rather a question for the entire field. Moreover, I think we know the answer to this already. All audiologists must use evidence-based, best-practice techniques to verify and validate patients’ experiences to ensure value-added to the equation. Furthermore, we need to ensure we are holding ourselves accountable and pushing for 100 percent best-practice compliance across the field. Audiology has a real opportunity to steer hearing care, but it's not going to work if we're all working in silos.

Throm: Most of us just need to keep doing what we are doing. The de-valuing of hearing aids can offer added value to the professional. It's not all about the hearing aid! A good community-based marketing program will educate local communities on the importance of hearing health care, including counseling and aural rehabilitation, which will be more important than ever. However, our services are not free. OTCs may bring in a few earlier adopters of hearing aids but at a $300 or more price tag with minimal technology and poorer sound quality, these devices may not be bought by the same consumers the second time. I think this is the real concern: Will consumers equate OTC hearing devices as the end-all and be-all and give up if these don't work for them?

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