Events | April 2017 Hearing Review
The 2017 Elite Hearing Network Business Summit brought together approximately 1000 hearing care professionals and industry experts for three days of educational and networking opportunities, as well as several special events, at the Hard Rock Resort and Casino in Punta Cana, Dominican Republic. This year’s Summit theme was “Elevate Your Independence,” focusing on how independent hearing care professionals can succeed in an era of disruptive technology, distribution, and what may ultimately be a new regulatory environment. The conference seminars also included how to benefit from enhanced business intelligence (BI) and marketing strategies.
Overcoming Disruptive Forces
Like several of the national professional conferences in the past year, this year’s Summit looked at the ongoing potential legislative changes that could affect the future of hearing aid dispensing. However, as reported in several Hearing Review articles, Elite and its parent company, Amplifon, have played a leadership role in adding substantively to the discussions of influential organizations like the National Academy of Sciences (NAS) and the US Food and Drug Administration (FDA) about the value of professionally fit and serviced hearing aids. Thus, both Amplifon and Elite have unique insights into the unfolding proposed changes in hearing healthcare.
In his opening General Session address, Elite Hearing Network Senior Vice President Paul Harkness evoked the “Elevate Your Independence” theme, likening the current situation of being an independent hearing care practice owner to climbing a mountain; the journey can be painful and difficult, but also incredibly rewarding when you can overcome substantial obstacles together. “[Elite] is the only group that, both privately and publicly, is fighting on your behalf to protect your independence in these increasingly uncertain times,” said Harkness. “With regulatory changes, increasing competition, and new distribution concepts, it’s paramount that we adapt our strategies to serve. Make no mistake, there will be icy conditions, howling winds, unexpected storms, poor sleeping conditions, and even lags in energy—but we must find a way. We’ll be there every step of the journey to provide you what you need, when you need it…A solid foundation of support is critical for supporting your goals…because none of us are in this alone and none of us can do this on our own. The entire network will be there to fill up your canteen, secure your carabiner, replenish and pack up your supplies, and keep you moving upward. We can push you to continue when you’re tired; we can throw you a rope when you’re feeling unsure. We may indeed be independent, but together we are also united and strong. Together we can elevate our independence to achieve greatness.”
OTC: Where Is the Evidence?
One of the most prominent voices at the recent FDA and NAS conferences has been Heinz Ruch, executive VP of Amplifon Americas. At the Summit’s General Session, Ruch provided a timeline and review of the key landmarks in the over-the-counter (OTC) hearing device debate during the past two years, and offered his perspectives on them:
- October 2015: President’s Council of Advisors on Science and Technology (PCAST) report. PCAST made four recommendations, including the creation of a new hearing aid category that would essentially exempt personal sound amplification products (PSAPs) and similar devices from FDA regulations.
- April 2016: FDA Workshop “Streamlining Regulations for Good Manufacturing Practices (GMPs) for Hearing Aids.” This workshop asked if current Quality Standard Requirements (QSRs), as well as the required quality control and complaint processes, were acting as an undo barrier to entry for potential hearing innovators. Both Elite VP Training & Development Thomas Tedeschi and Ruch participated in the podium discussion of that meeting, affirming that the QSRs did not pose a substantial barrier to innovation in hearing care and were appropriate for protecting the consumer. It was at this point, says Ruch, that the FDA entered into a “talking mode” relative to considering an OTC device category.
- June 2016: National Academies of Sciences (NAS, formerly the Institutes of Medicine) report on “Accessible and Affordable Hearing Health Care for Adults” which made 12 recommendations, including the creation of an OTC device category with labeling stipulations and the abolishment of the “physician waiver” system that required medical clearance by a physician prior to purchasing a hearing aid or the signing of a waiver by the consumer.
- December 2016: NAS Dissemination Meeting “Conditions for Sale for Air-conduction Hearing Aids.” QualComm, Samsung, and Bose publicly backed changes to the current regulations, and Eric Mann of the FDA announced that the FDA will no longer enforce the hearing aid waiver system for adults that had been in place since 1977.
- April 2017: The Federal Trade Commission (FTC) will hold the workshop, “Now Hear This: Competition, Innovation, and Consumer Protection Issues in Hearing Health Care.”
In particular, Ruch in his testimony at these meetings has emphasized the need for regulation to rely on solid scientific evidence. With regard to the potential creation of a new OTC category, he points out that no evidence exists for making such a drastic change to the Hearing Aid Rule or for the adoption of a new, less restricted class of hearing devices for consumers.
“We have to take public safety and patient outcome results into account,” says Ruch, “because [OTC hearing aids] might backfire. The idea of increasing affordability and accessibility as envisioned by those who support OTC devices could result in a decrease in customer satisfaction, and a decrease in customer satisfaction will then probably trigger lower penetration rates—not higher penetration rates…A lot of pressure has been put on to FDA from different angles [to create an OTC category]. PCAST is a council coming directly from the President and the executive branch; then you have the scientific arm which is the National Academy of Sciences, although they really don’t have any real evidence [to support the notion that OTC would increase the adoption rate], but it still looks good in the eye of the consumer that there is [support] from the scientific body; and last, but not least, you have the legislative branch also putting pressure on the FDA.”
Ruch says that, because FDA appears to be deviating from its policies of 2004 and 2009—periods when it declined to change the Hearing Aid Rule based on available data—the Agency should again have data that would justify changing regulations on the distribution of hearing aids. “But the easiest way to [effect change for the OTC proponents] is if the [Warren-Grassley] bill passes in both the Senate and the House. Then the FDA’s position will be that they must act because they have to react to a Federal law…So, we keep bringing forward the arguments [regarding safety, outcomes, and the value of professional services] because we believe any such change in hearing healthcare should only be done from evidence-based knowledge by the FDA, which should be an evidence-based organization.”
At the June 2016 NAS meeting, when Ruch asked Committee Chair Dan Blazer, MD, what scientific evidence the Committee had that an OTC hearing device category would improve the market penetration of amplification or lead to more successful use by consumers, Dr Blazer admitted that NAS had no evidence, but, rather, saw it as a relatively low-risk move. “It’s probably worth saying,” said Dr Blazer at that meeting, “if we see this go through the FDA and this device category is approved, there definitely will need to be studies on the effectiveness of [OTC] devices…there needs to be more evidence, but we feel there needs to be a move forward to opening up options now” (see p 10 of the July 2016 Hearing Review).
Elevating professional care. Following Ruch at the Summit’s General Session was Jan Kihm, who specializes in consumer surveys and, with Harvey Abrams, PhD, was responsible for the consumer-based data in MarkeTrak 9 (MT9), (published in the June 2015 Hearing Review). More recently, Kihm and Amplifon VP of Training and Development Thomas Tedeschi, AuD, published a pilot study in the March 2017 Hearing Review about consumers’ use and satisfaction with OTC hearing aids compared with the current professional model. Kihm reviewed this study’s data which indicates that individuals supported by a hearing care professional experienced significantly better participant outcomes across all metrics, including daily usage of the hearing solution, how well each solution met expectations, overall satisfaction rates, the incidence of individuals who stopped using the hearing solutions before the end of the trial period due to dissatisfaction (ie, “instruments in the drawer”), and willingness to recommend—which is a strong indicator of patient outcome and also of perceived success.
Elevating teamwork. Thursday’s General Session was capped off with an inspiring speech from mountaineer and adventurer Alison Levine, who led the first all-women’s team to climb Mount Everest. Levine explained that most people don’t realize that climbing Everest entails an entire two-month series of back-and-forth ascents and descents from the base camp and numerous other camps before actually attempting to climb to the summit. She says this proves progress doesn’t always happen in one direction. “Backing up is not the same thing as backing down,” says Levine. She also described in heart-wrenching detail how, after a grueling two months, her team was only a few hundred meters from the peak when their climb was scuttled due to a sudden blizzard that could have proven deadly. Although Levine returned several years later and was able to get to the top of Mount Everest, her real message to Elite independents was about teamwork, tenacity, and the understanding that “Nobody gets to the top of the mountain by yourself…Be relentless in putting one step in front of the other.”
Educational Sessions and Events
Elite Hearing Network, which is a part of the Amplifon group (including Amplifon Hearing Healthcare and Miracle-Ear in the United States), was spun off from Sonus in 1998 and now encompasses about 1,500 offices. Besides a focus on the network’s offerings, the Business Summit also showcases Elite’s partners: some of the industry’s most prominent hearing aid manufacturers, special equipment suppliers, and service providers. These partners took the spotlight during a three-hour crowded expo and trade show on Friday evening, as well as a series of educational seminars that spanned the three-day event. Other special sessions included networking lunches and breakfasts, an Awards Banquet and Reception, and the Operation Sandcastle Fundraiser.
Coming in 2018. The 2018 Elite Hearing Network Business Summit will be held on February 14-18 at the Grand Coral Fiesta Americana in Cancun. For more information about the Elite Hearing Network, visit: www.elitehearingnetwork.com. —KES
Citation for this article: Strom KE. Elite 2017 Business Summit elevates independents in era of disruptive change. Hearing Review. 2017;24(4):36-38.