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Readers React: Survey Gauges Reactions to PCAST and NASEM Recommendations

Newitt, Valerie Neff

doi: 10.1097/01.HJ.0000521753.76085.88
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A well-circulated yet still jarring statistic—that only 15-30 percent of an estimated 30 million people over age 60 with hearing loss in the United States seek treatment—was an opening salvo in the President's Council of Science and Technology Advisers’ (PCAST) October 2015 report that called out the high cost of hearing aids and the lumbering pace of innovation within the hearing health care industry. Eight months later, the National Academies of Sciences, Engineering, and Medicine (NASEM) heaped more finger-pointing at the hearing health community in a report, suggesting that an overhaul of “key institutional, technological and regulatory” standards is necessary to “enable consumers to find and fully use the appropriate, affordable, and high quality services, technologies, and support they need.”

How do these reports, in concert with the bipartisan OTC Hearing Aid Act of 2017 now before Congress, sit with hearing health professionals? The Hearing Journal surveyed readers to gauge their knowledge of the reports, opinions on the contents, and expectations for the future of hearing health care providership. Survey methodology and results, revealed in the following pages, surface some interesting revelations.

Among them is the fact that while many survey respondents have heard of the reports, only 23 percent were “very familiar” with the PCAST report, and even fewer—15.1 percent—were “very familiar” with the NASEM report.

It is a reality that raised a red flag for audiologist Jackie L. Clark, PhD, clinical professor at the School of Behavioral & Brain Sciences, UT Dallas/Callier Center, and a member of The Hearing Journal's editorial board. “As president-elect of the American Academy of Audiology, I am concerned that we have any members who are not aware of the recommendations by PCAST, NSAM, FDA and FTC,” she commented. “…No doubt, we have found ourselves in a dramatically changing landscape that requires us to unfailingly engage in stellar best audiological practices and join arms while using our unified voices to advocate to consumers, policymakers, and the media about the immense value offered by audiologists.”

Upon reviewing survey results prior to publication, Fan-Gang Zeng, PhD, professor of otolaryngology and director of the Center for Hearing Research at the University of California, Irvine, as well as chairman of The Hearing Journal's editorial board, cautioned, “Most of our readers may have not realized how much the two reports and the pending bill will affect their business practice, but they need to.”

The Hearing Journal's survey educated and engaged readers by enumerating some of the clarifying statements of the two reports and giving respondents an opportunity to weigh in on them.

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PCAST calls for:

  • a more open market via FDA approval of OTC hearing aids without a requirement for professional consultation for mild-to-moderate hearing loss and,
  • FDA withdrawal of the 2013 draft guidance on PSAPS,
  • more consumer choice, hence audiologists and hearing aid specialists who perform diagnostic hearing tests and hearing aid fittings must provide patients with copies of their audiograms and programmable audio profiles usable by any other vendor and,
  • an FTC process by which patients may authorize hearing-aid vendors to obtain a copy of their hearing test results and programmable audio file from any audiologist or hearing aid specialist who performs such a test at no additional cost.

NASEM makes 12 recommendations to:

  • improve population-based information on hearing loss/hearing health care (support and conduct studies to better understand risks, co-morbidities, needs, impact of hearing loss and treatment, etc.),
  • develop/promote means to access/improve quality of hearing health care services (promote best practices and core competencies, implement mechanisms to ensure adherence and metrics to evaluate quality of care),
  • remove FDA's regulation for medical evaluation or waiver,
  • empower consumers/patients to use hearing health care (explain their rights to access their health care information),
  • improve access for underserved and vulnerable populations (via telehealth, outreach clinics, etc.; promote diversity and cultural competency in hearing health care workforce, etc.)
  • promote hearing health care in wellness and medical visits,
  • implement new FDA device category for OTC wearable hearing devices (with options for accessory tests for self-assessments for selection and fitting),
  • develop compatibility and interoperability of hearing technologies with communication systems, and implement an open platform approach that would allow any hearing health care provider (or potentially the consumer as technology evolves) to program device settings,
  • improve affordability of hearing health care (including transparent fee structures by providers, CMS reimbursements, etc.),
  • innovate models of hearing health care to improve access, quality, and affordability (exploiting, for example, community health workers, telehealth, mobile health, retail clinics, self-administered hearing health care, etc.),
  • improve public education on hearing health (provide public access to evidence-based information on hearing through websites, health fairs, social media, marketing, education campaigns, standardized terminology, and more), and,
  • promote actions across all sectors (individual, employer, private, community) to support and mange hearing health and effective communication.
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When asked for general agreements or disagreements on the reports’ recommendations, respondents’ emotions and responses were direct.

“I absolutely disagree with this concept,” said respondent Kenneth Henry, PhD, associate professor and clinical program director of the Department of Hearing, Speech, and Language Sciences at Gallaudet University, Washington, DC. “We all know that this is a price and access issue for services for the hearing impaired.”

During a post-survey interview, Henry said he'd just returned from an April visit to Capitol Hill where legislators told him the OTC Act, a bipartisan initiative, is certain to pass. “What permutations or modifications it will pass with and exactly what benefits it will provide to the consumer remains to be seen,” he commented. “Medicare recipients have long complained that hearing aids are a non-covered service and that the out-of-pocket costs are extraordinarily high. Legislators are well aware of the access issue of their Medicare constituents. My perception is that this is part of what is driving this whole model [of OTC access]. It is a way of being sure constituents get ‘something’ for their hearing that is affordable, yet it won't impact CMS—Medicare and Medicaid still won't have to pay for it.”

Zeng suggests, however, “future hearing aids will likely be divided into OTC and regulated medical devices, which would likely be reimbursed by Medicare and other insurance companies.” Until all of the details of the final act are worked out, suppositions vary.

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Asked if the OTC Act, along with PCAST's and NASEM's support of OTCs, will indeed result in greater access to hearing aid technology for a larger population of people, survey respondents generally affirmed that access will be expanded but at an unacceptable cost of poorer outcomes.

“Greater access by itself, can be a double-edged sword,” said one respondent, adding, “There are many potential pitfalls for the overall well-being of the consumer.” Another respondent agreed, “The medical attention of the patient is being disregarded by the passing of the OTC bill and the reports … Hearing aids are seen by both PCAST and NASEM as a retail and sales delivery model. Quite sad.”

Yet another respondent voiced a similar concern, saying, “Allowing greater access does not translate into patients understanding how to use and care for their instruments, the realistic expectations associated with particular instruments (OTCs) and their hearing impairments, nor does it ensure that the instruments are programmed properly for maximum benefit. I see a potential for patients believing—once again—that hearing aids will not work for them. It took decades for audiologists to educate the public, government, etc., to understand the complexity of programming each instrument to suit the unique needs of each person's hearing loss; I see these proposals as undoing a lot of that work.”

Henry, too, made clear his deeper concern under the models set forth in the PCAST and NASEM guidelines. “Essentially consumers must self-diagnose the level of their hearing loss,” he said. “But how are they going to know if they have hearing loss in one ear or both? Or assymetrical hearing loss? A common complaint I hear from people is, ‘I can hear OK, but I can't understand what is being said.’ What hearing loss level does that fall into? Moderate? Mild? How do consumers make that determination on their own?”

Henry and other respondents also question just how much meaningful access would increase, given a similar effort to make OTCs available in Japan that proved unsuccessful. According to a presentation on the FDA website, hearing aids are readily accessible in Japan. Because do-it-yourself OTCs and PSAPs are sold for hearing loss, “… essential professional service is often skipped.” Compared with European and U.S. models of hearing health care delivery, Japan has the “worst adoption rates and the worst satisfaction rates.” The presentation concludes: “Access does not equal adoption or good public health outcomes.”

Another respondent similarly remarked, “In China and South Korea where OTC hearing aids are unregulated, consumer satisfaction with these devices is low. OTC PSAPs may be a good entry point for individuals with mild hearing loss, however, there needs to be FDA guidelines in place to ensure that patients receive appropriate testing and counseling before choosing this option.”

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The survey also surfaced a general consensus among respondents that cost is a primary barrier that is pushing the OTC agenda forward. And while cost-cutting will open a financial gateway to consumers, some hearing health professionals are understandably concerned about its effect on their professional livelihood.

“Greed in more than one arena has led to these issues that we are facing. Today manufacturers are charging us [hearing aid service and sales providers] what we used to charge retail years ago, and that is forcing us to charge consumers more or make less money,” said respondent Sharon P. Mullen, HIS, of Hear Here Hearing Aid Sales & Service, New Prague, MN. “We have made a living doing this for over 20 years and it scares me, to be quite frank. I wonder how I am going to make a living.”

She continued, “I see that smartphones and such will definitely change the way hearing instruments are fit in the future and that younger generations will be using some form of Bluetooth speakers/head sets. I see that technology is changing, but I feel this is being rushed into without proper consideration of the effect it will have on our hearing loss population and hearing professionals. I do not feel that hearing professionals are being heard on these issues… This has been a high drama industry to work in at times. It was bound to come to a head. My disagreement with this is entirely coming from fear for my own survival.”

Another concerned reader agreed, “If we open the floodgates to low-cost options, how will the professionals, hearing instrument specialists, or audiologists even make a living? That hasn't even been looked at. So, now you will have low-cost options that honestly may or may not work, but you will have the lowest educated people fitting them because it will be a minimum wage job. How is that going to work? These two reports are not taking enough of the variables into account.”

Some respondents found fault with Big Box retailers whose undercutting prices make possible access to cheaper devices. But “access is one thing; efficacy is another,” reminded one respondent. “Buying an inappropriate aid over the counter, without guidance or support, may not provide any benefit.”

However, another participant, who agreed to a post-survey interview, offered a very different perspective on the supposedly dark shadow cast by retailers such as Sam's Clubs and Costco, both mentioned disparagingly by respondents.

David Harris, BC-HIS, BEd, practices with Costco Hearing Center in Spanish Fork, UT. “Many within our industry tend to look down upon Costco hearing centers, believing we provide an inferior product and service,” he said. “This is not true. Costco has set a national standard for our testing protocol that complies with the most stringent state requirements. We also have negotiated with manufacturers to provide premium-level products to our members at affordable prices… With the general price for a set of premium hearing aids ranging between $4,000 and $6,000, it's no wonder the movement and support for the recommendations of PCAST and NASEM have increased over the years.”

While he was strong in his defense of Costco, Harris, too, believes problems wrought by PCAST and NASEM recommendations would far outweigh the cost benefit they aim to achieve.

For example, “Most patients with mild to moderate hearing loss have specific frequencies that are deficient and can only be discovered through audiometric evaluation performed in a sound-controlled environment using ANSI-certified equipment,” said Harris. He also noted, “NASEM's report was focused on two types of individuals—older adults and transitioning young adults. Both of these demographics require professional guidance and training to accurately fit hearing devices to their hearing loss and lifestyles. If these individuals just were allowed to purchase broad-spectrum hearing devices without professional evaluation, fitting, and follow-up training/care, the majority of them will not be fit correctly over time. Furthermore, removing the need for medical evaluation or waiver could also expose these individuals to medical issues that could be discovered through professional screening/care. Although the medical issues that we find are rare, we still do find them—thus saving lives or improving health outcomes. I agree cost needs to come down, but not at the expense of service and care by licensed professionals.”

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The gist of Harris's latter concerns was repeated by many, if not most, survey respondents. But one participant, R.D. “Dan” Taylor, ACA, BC-HIS, in practice in Melbourne, FL. for 25 years and in the field for 35 years, elaborated on a very different perspective in a post-survey interview. Also founder/CEO of Mission Hearing, a certified not-for-profit organization, Taylor claimed he is considered “a real heretic” by some in his profession, given his support of more access at all levels.

“Our industry and profession have treated consumers as ignorant children, incapable of understanding their condition, or even acting in their own best interest, absent the intervention of one of our approved professionals in the process,” he said. “We have promulgated endless procedures, processes and surveys that we would force upon every consumer seeking help for a hearing loss.”

He continued, “Our profession has created, then conflated non-existent risks of grave consumer harm … all in an attempt to maintain our self-proclaimed superior judgments as to what is best for every person seeking hearing help, while attempting to continue to substitute our best interests for those of the consumers we would serve.”

Taylor believes the hearing health care community has maintained a delivery system that maximizes industry and professional profits by controlling and limiting “access above consumer choice, by refusing to allow consumers to add any value after their initial sale, or to even choose the level of professional involvement that they deem best for themselves.”

He staunchly supports open platform fittings and non-proprietary software, noting both are major factors in limiting access and driving up costs. “These would allow the industry to offer, and the consumer to purchase, a lower-cost, basic system that could then be upgraded as additional applications became available,” he said.

“The vast majority of my colleagues are caught on a raft of their own prejudices, floating down the river of denial. Our industry has controlled things for so long that they simply fail to see that that control is ending. Forces larger than our own industry are at work. Everything about the way we shop, buy things, and seek out professional care has evolved. Everything our industry is doing is to fight the natural changes brought on by the evolution of both our consumer and the equipment that we use to serve them… If my colleagues and their myriad of protocols and best practices so bandied about do, in fact, add so much value to the process, why aren't they willing to simply educate the consumer to this great value and compete for their hearing health care dollar in an open and free marketplace?” Taylor asked. “Very simply, hearing aid regulation and industry control over who can sell and dispense ear level sound processing gear is an idea whose time has come and gone.”



Taylor's comments were not typical, however. More representative were cautionary comments, such as these from Laurie Bornstein, MS, CCC/A. “Over-the-counter access to hearing aids will likely increase the number of consumers who receive a less-than-optimal, or even detrimental, approach to a hearing loss problem that may eventually increase cognitive decline. If it turns out to be true that untreated hearing loss contributes in any way to loss of cognitive function, then I would posit that inadequately treated hearing loss may have similar effects. It's my opinion that untreated/improperly treated hearing loss could turn out to be one of the major public health issues of the next couple decades. Hearing involves the brain in so many important ways that I believe it is not something to be toyed with. At the very least, more research needs to be done before the treatment of (even self-diagnosed ‘mild’) hearing loss should be allowed in the hands of the layman,” said Bornstein.

“There are good reasons that becoming an audiologist now requires a doctoral degree. It might behoove the FDA to listen more closely to the opinions of audiologists, who have significantly more knowledge in this matter than an average baby boomer who just thinks, ‘Everyone mumbles these days,’ or a hearing aid manufacturer who likely wants to be on the forefront when sales roll in… Audiologists are the ones to ask,” she insisted.

Editor's note: For a discussion on how hearing professionals can acclimate to PCAST and NASEM recommendations, read the supplementary article online:

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