What will the audiologic landscape look like once the reality of the Over-the-Counter (OTC) Hearing Aid Act of 2017 hits in 2020?
A task force of Sherlock Holmes, Charlie Chan, Steve McGarrett, and Andy Sipowicz would be hard-pressed to solve that mystery.
A major reason is because the U.S. Food and Drug Administration (FDA), which currently holds all the cards, is providing little to no clues on what parameters will be set.
“Unfortunately, we are unable to speculate on future proposed regulation,” affirmed FDA spokesperson Angela Stark. “We are also unable to speculate on a timeframe for the process to make hearing aids available over-the-counter.”
While the FDA has three years since the enactment of the act to prepare regulations for this new category, the agency has provided no hints on how other agencies like the CMA or VA would be affected. Meanwhile, Neil DiSarno, PhD, the chief staff officer of the American Speech-Language-Hearing Association (ASHA), is guarded in his optimism that concerns of the audiology community will be met.
“Although the FDA continues to solicit input regarding specifications of the devices that would fit in this OTC category, there is considerable expectation that under FDA guidelines, the devices would be safe,” he said. “Until we see the final specifications, concerns continue to exist regarding safe levels of gain and output of these devices.”
Earlier this year, The Hearing Journal conducted a readership survey on the expected impact of OTC hearing aids. It served as a follow-up to our 2017 survey http://bit.ly/2I68zUO that gauged the knowledge and opinion of our readers on the OTC Hearing Aid Act as well as the PCAST and NASEM reports that were instrumental in shaping the provisions of the Act. The 2018 survey reveals that while audiologists are bracing for impact, they are trying to be as proactive as possible under the peculiar circumstances of hanging in suspended animation. Unlike some professions—such as journalism, where the change from print to the Internet was like a blindside hit on the quarterback—audiologists know change is coming.
While 27.2 percent of the respondents to the reader survey expect no difference on their patient intake due to OTC hearing aids and 10.1 percent expect a major impact, 62.7 percent expect a minor impact.
A highlight from this year's survey, the overall results of which were more or less in line with our 2017 survey results http://bit.ly/2I68zUO, is that 81.5 percent believe that audiologists should take “some sort of action,” with 70.4 percent pointing to promoting other services.
“The opportunities presented because of the introduction of OTC devices allow audiologists to take a fresh look at the services they offer or could offer, and the methods in which they offer services,” added DiSarno. “Although there are likely to be some negative impact on those who may have chosen an inappropriate device, or those who are unable to adjust to or adjust the device, there certainly can be some positive outcomes for audiologists.”
Having audiology assistants is one example that DiSarno cited. “From a market analysis, we have found that those audiologists who use assistants have reported increased productivity and greater patient satisfaction.”
THE GUIDING LIGHT
In an attempt to clear up the muddied picture, Ian Windmill, PhD, the clinical director of the Division of Audiology at Cincinnati Children's Hospital Medical Center, played a key role in developing the American Association of Audiologists (AAA) guide to help prepare audiology professionals for the future.
Windmill explained that “the genesis” of the Audiologists’ Guide was “the necessity to provide the audiology community with a resource that summarized the history and current standing of the statutory and regulatory requirements for OTC devices, as well as compare and contrast OTC devices with other forms of amplification technology.”
Questions submitted to the AAA leadership revealed obvious and realistic ground-level concerns about the impact of OTCs. “We decided to pull together the information, as was current at the beginning of 2018, into a single reference document that could inform and educate the audiology community,” Windmill said. “The Academy had committed significant resources to engaging Congress about the OTC bill, and subsequently to engage with the FDA about the process and possible outcomes.”
These resources, he said, included subject matter experts in the area of technology for the treatment of hearing loss, and individuals with experience in regulatory processes. These experts were also tasked with developing the OTC guide for audiologists.
All these variables, and what they could entail upon the full implementation of the OTC Hearing Aid Act of 2017—which was part of a larger FDA funding bill—combined to “trigger” the development of the AAA Guide, which also addressed hearables and personal sound amplification products (PSAPs) already on the market.
“The dilemma for the Academy, and for the audiology community as a whole, is that there is no such thing as an OTC hearing aid today,” he said. “As such, any attempt to specifically define OTC hearing aids, determine possible distribution channels, identify manufacturers or price points, or consider the impact on the existing hearing aid market, was speculative at best.”
PAST IS PROLOGUE
Opinions within the audiology community varied about the impact of OTC devices on audiology practices, varying from “doom-and-gloom” to significant opportunity. The Audiologists Guide did not attempt to speculate as to the possible impact, only to put OTC into current context.
While it is best to have trained professionals treat those with hearing challenges, factors such as hearing loss not being considered a disability and the cost of hearing devices have led to a sobering statistic—an estimated five out of six people do not acquire devices because of the cost—that equates to wobbly legs that the audiology community itself cannot afford to stand on.
This was the genesis behind the OTC Hearing Aid Act of 2017, which achieved a true rarity by gaining support from both sides of the aisle in a bitterly divided Washington, DC.
The measure aimed at making hearing devices more affordable was part of a larger bill—the FDA Reauthorization Act of 2017—that challenged the FDA to theoretically begin working in the best interests of U.S. citizens. Also covered under this larger umbrella were the likes of the Right to Try Act (ability for terminally ill patients to use experimental drugs) and hastening the use of generic drugs.
On July 24, 2018, the FDA issued a letter http://bit.ly/2KiTi3s reaffirming the deadline (Aug. 18, 2020), the period for public comment, and the 180-day window for the FDA to publish final regulations, and asking manufacturers to “be mindful” of state law requirements.
The historical model of treatment for hearing loss has been hearing aids, according to Windmill, adding that “amplification, whether embedded within a hearing aid or some other type of device, will continue to be an important treatment modality.”
He advised a new perspective is to “reframe the thought process away from hearing aids” and more towards “amplification,” which then affords the opportunity to broaden the types and forms of technology available to people with hearing loss or perceived communication difficulties, and therefore serve more individuals.
“This also requires the recognition that selling products such as PSAPs, hearables, or even OTCs when they become available, can be a benefit,” he said. “In the dermatology world, physicians sell skin care products ‘over-the-counter’ with the expressed intent of improving outcomes. Persons purchasing skin care products in an office can be guided to the correct product, can be provided specific instructions that can improve compliance, and can combine products with other treatment options. The same could be said for hearing care products. The opportunity to expand technologies to improve outcomes can be a differentiating factor for practices.”
In The Hearing Journal reader survey, increases in patient volume—91.2 percent in small group practice, 83.7 percent in large group practices, and 74.5 percent in private practices—are expected from survey respondents, citing anticipated OTC problems as a major reason.
“Hospitals with larger numbers of audiology staff may have the opportunity to offer programs for persons with impaired hearing who may not be ready to be fit with, or be able to afford high-end devices,” said DiSarno. “These programs could introduce patients to amplification with OTC devices and offer rehabilitation to address their communication deficits. Once these patients become familiar with your practice and your services, they would be expected to remain patients when devices other than OTC are necessary. Again, the use of assistants may allow small group practices to offer similar programs.”
Windmill believes it could be more nuanced, going beyond large practice vs. small practice vs. private practice.
“There will be differential impacts on services provided within practice settings such as the VA hospital system, pediatric facilities, private practices, and ENT-based practices,” he said. “Some speculate that the more a practice is reliant on hearing aid sales, the greater the potential impact. This makes sense from the perspective that OTCs are believed to compete within the amplification marketplace, and not with practices with diverse revenue streams—cochlear implant, vestibular, pediatric, etc. Moreover, those practices where compensation is tied to productivity—such as private practice—may be more inclined to believe that OTCs, PSAPs, and hearables will have a greater impact than those practices where the audiologists are salaried, such as pediatric hospitals.”
Whether audiology professionals come from a place of “doom-and-gloom” or see a chance to make hay, Windmill advises both to remain flexible.
“The impact of OTCs on any audiologic practice is difficult to predict so a wait-and-see approach is understandable,” he noted. “When the timeline for roll-out of OTCs is factored into the equation, the wait-and-see approach is even more understandable. The FDA has indicated they will take the full three years before the proposed regulations are published. Then the review and comment period will occur prior to any final rules being published, which will extend the introduction of OTC devices even further. Distribution channels, informing the public, and impactful uptake of OTC devices will also take time, once again pushing out the time frame for understanding the true impact. We are likely looking at four to five years before we can understand the impact on hearing care broadly and audiology practices specifically. So it probably is wise to not overreact at this point in time.”
A key element, an X-factor, during the intervening years is the development of amplification technology that will—or will not—occur.
Said Windmill: “The OTC legislation has provided the opportunity for those practices that provide adult amplification services to consider additional ways to enhance services. In some respects, it has identified a price-point—and a service-point—that could be integrated into practices to broaden the number and/or type of patient served. Patients who cannot afford traditional amplification technologies could be served with in-office technologies—hearables, PSAPs, and in the future, OTCs—that may meet their needs. Consideration could also be given to providing technologies that might counteract communication difficulties for persons with normal pure-tone audiograms.”
This bring us back to the wait-and-see approach, explained Windmill, who added that “the true impact of OTC devices may be difficult to tease out of the overall evolution of amplification technology and environmental forces.”
In a scenario strewn with its share of unknowns, there is a certainty while the audiology community waits this one out.
“Over the next five years, there will be a continued growth in the population over 65 as the baby boomers continue to age,” said Windmill. “This factor alone may counteract any negative impact by OTC devices. So, the bottom line is that practices could be considering opportunities to enhance their services, but not due to the introduction of OTC devices.”
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