AudiologyNOW! 2017 Dominated by OTC Discussions

Events | July 2017 Hearing Review

The American Academy of Audiology (AAA) held its 29^th Annual AudiologyNOW! Convention on April 5-8 in Indianapolis, Ind, attended by an estimated 3,300 audiologists and students, with a total attendance of 4,849 (about one-third of the attendees being exhibitors) and about 9% of all attendees hailing from outside the United States.

This year’s convention theme, “Connect, Reconnect, and Innovate in INDY!” reflected the Academy’s desire for its members to forge new relationships, strengthen existing ties, and engage in the learning opportunities afforded to them during the 4-day conference. The convention kicked off on Wednesday, April 5, with the Academy Research Conference which focused on the advancements in pediatric assessment and rehabilitation led by Ann-Marie Tharpe, PhD.

Numerous other special events included featured sessions and seminars, learning modules and labs, poster sessions, industry updates, student events, a 5K run/walk, morning coffee and yoga sessions, and the conference was capped off with a Friday evening of minor-league baseball at Victory Field to see the Indianapolis Indians battle the Toledo Mud Hens. This year’s AudiologyNOW! Program Chair was Rebekah Cunningham, PhD.

The exposition portion of the event featured over 160 companies, organizations, and universities. Beyond the omnipresent chatter about over-the-counter (OTC) and hearable devices, this year’s convention floor buzz centered on rechargeable hearing aid technology, teleaudiology and remote programming, and made-for-Android hearing aids—as well as the related subject of enhanced wireless connectivity. Virtually all major hearing aid manufacturers had some type of innovative feature, app, or new platform that embodied one or all three of these technology themes.

Talk of OTC Dominates Convention

Most AudiologyNOW! General Assembly meetings feature the Academy’s pursuit of numerous professional and legislative initiatives, such as open access to audiologists or accreditation issues. Although the Academy continues to work on these, talk about the proposed changes in hearing aid distribution and what impact the Over-the-Counter [OTC] Hearing Aid Act of 2017 might have on the future of US hearing aid dispensing relegated other issues to the back bench.

At the General Session, AAA President Ian Windmill, PhD, said the past 18 months have placed hearing healthcare squarely in the spotlight of Washington, DC, legislators like never before. The OTC Hearing Aid Act, introduced in March by Senators Elizabeth Warren (D-Mass) and Chuck Grassley (R-Iowa), would require the US Food and Drug Administration (FDA) to propose an OTC hearing aid category for adults with “perceived” mild-to-moderate hearing loss within 3 years of passage of the legislation, and finalize a rule within 180 days after the close of the comment period. The proposed legislation (which has since passed through committee) would also require the FDA to write regulations ensuring the devices meet standards for safety, consumer labeling, and manufacturing protections, providing consumers with the safe option of an FDA-regulated hearing aid at a lower cost. Importantly, the Act would supersede other state laws restricting OTC device distribution, and also provide for a study of the devices relative to consumer satisfaction after 3 years. Although AAA initially raised some concerns about items in the President’s Council of Advisors on Science and Technology (PCAST) report, it has taken a more neutral stance on the National Academies of Science, Engineering and Medicine’s (NASEM) recommendations—both of which advocate for an FDA-regulated OTC device classification.

“But it will be the FDA that decides whether to allow an OTC device for hearing care,” said Windmill. “The FDA’s focus is patient safety, and they’re going to evaluate and determine if OTC hearing devices can be used safely and any necessary rules that need to be in place to assure their safe use. As many of you know, the FDA recently stopped enforcing the need for a medical evaluation or a medical waiver prior to obtaining a hearing aid. I expect that soon they will propose new rules to allow direct-to-consumer (DTC) amplification and at the same time eliminate the medical evaluation waiver requirement.”

Windmill said the NASEM report included multiple recommendations and can be considered a blueprint for FDA clinical and policy changes necessary to improve access and reduce costs. NASEM’s recommendations also included the need to collect and report prospective population data on hearing loss and outcomes, to ensure adherence to established best practices, and to itemize the price of technologies and related services. “The truth is the audiological community has been beat up in the past years due to our lack of clarity about who we are and what we do,” said Windmill. “We tout our evidence-based profession but are inconsistent in following best practices; we point to our post-graduate education, but we have not differentiated ourselves from other providers; and we assert our value in the hearing care process in spite of paltry evidence to make such claims. Because of those declarations, we are being held to a higher standard, but our failure to meet these standards has resulted in greater scrutiny and reprimand. Conversely, we’ve also been handed the opportunity to be the solution for all these issues of access and affordability in hearing care. Because of this same education, our clinical standards, and our ability to generate the evidence, we are being challenged to make a difference in the delivery of hearing care in the United States. It is a challenge we gladly accept.”

More recently, the Federal Trade Commission (FTC) also held a public workshop examining the delivery of hearing care from their perspective as a consumer protection agency. Windmill said the FTC could be considering the impact of licensure laws on competition, or require the unbundling of products from service, or they could examine the relationship of practices with manufacturers. He says the Academy has been fully engaged in providing information and collaborating with Senators Grassley and Warren’s offices on their bill along with other professional and consumer organizations.

“So where does this leave us?” asked Windmill. “Well…we can be confident that ear-level technologies will continue to evolve. The ability to combine amplification, biometrics, music streaming, language translation, and audio curation is not a question of ‘if,’ but a question of ‘when.’ The era of hearables that provide amplification is upon us. And, like it or not, it’s probable that regulations allowing OTC devices will be issued. Whether these are categorized as hearing aids, or PSAPs, or something else is still to be seen. And what impact this decision will have on the various practices remains unknown. But, truthfully, if we realize what our profession provides—expertise and understanding in the areas of hearing and balance, the functional impact of hearing loss and vestibular disorders, the skill-set to develop treatment plans, the ability to monitor and change those treatment plans as necessary, and accomplish treatment through measured outcomes—the issue of OTC products should not cause us great concern. Our core mission is not about selling products; it is about providing care for persons with hearing loss and vestibular disorders that occasionally involve amplification products.”

Windmill cited a meeting facilitator who recently remarked that our field spends more time preserving the status quo than it does seeking new opportunities to grow the profession. Preserving current patients and revenue at the expense of a future expanding patient base, revenue streams, or demonstrated value is not in the profession’s best interests, says Windmill. “So, as we consider the challenge of making hearing care more accessible and affordable to the consumer, there is an imperative that we simultaneously consider expanding our scope of services for ourselves,” says Windmill. “We can begin by thinking beyond the pure-tone audiogram and our traditional use of products. For example, there is no reason why we can’t offer a full range of technologies in our practices, including PSAPs or OTC devices, along with traditional hearing aids. This would go a long way to proving our commitment to improving access and affordability by offering our patients low-cost alternatives to meet their communication needs, while still offering the audiology services that we know lead to better outcomes.”

AAA Incoming President Jackie Clark, PhD, in her comments to the General Assembly said, “Isn’t it time we light the light in our own professional home? Really, it isn’t about us versus them [politicians, regulators, other professions, Big Box, etc], it’s about us versus problems. We cannot change the gale-force winds that are threatening this ship, but we can adjust strategically and engage our shared rudder to guide us through these uncharted rough waters we find ourselves in.”

Hearing care in a global context. The keynote speaker at the General Session was Shelly Chadha, MBBS, PhD, Medical Officer for the World Health Organization (WHO) Program for Prevention of Deafness and Hearing Loss. Dr Chadha, an otolaryngologist, has decades of experience in community ear and hearing care, planning and policy development, served as a member of the National Program for Prevention and Control of Deafness in India, and helped develop the Sound Hearing 2030 initiative in the South East Asia region. She emphasized that the growing need for hearing care and a general lack of policies to address it pose a significant public health challenge. The WHO program aims to develop and strengthen hearing care activities in its member countries via comprehensive hearing care strategies in partnership with governments and nongovernmental organizations. WHO is partnering with all stakeholders— international organizations, national governments, ear and hearing care—to create a global movement promoting access to hearing care for all, says Chadra.

Honors and New Officers

The Academy honored seven distinguished audiologists and industry experts during the convention:

• Jane R. Madell, PhD: Marion Downs Award for Excellence in Pediatric Audiology;
• James (Jim) A. Henry, PhD: Jerger Career Award for Research in Audiology;
• James (Jim) F. Patrick, MSc, DEng, CPEng(Biomed): Samuel F. Lybarger Achievement in Industry;
• Amy M. Donahue, PhD: Career Award in Hearing;
• Jose Juan Barajas de Prat, MD, PhD: International Award in Hearing, and
• John Greer Clark, PhD: Distinguished Achievement Award.

Lisa Christensen, AuD, was announced as the new AAA President Elect, and Melissa Heche, AuD, Francis Kuk, PhD, and Former-president Brad Stach, PhD (2003-2004), were elected as the new members-at-large whose terms begin October 1.

Next year

The 2018 AAA AudiologyNOW! Convention will be held in Nashville, Tenn, on April 18-21. For more information, visit www.audiology.org.