On Tuesday, April 18, the US Federal Trade Commission (FTC) held the workshop, “Now Hear This” which looked at the myriad issues surrounding technology and competition in hearing aid distribution, as well as how over-the-counter hearing aids might impact customer satisfaction, the use of amplification products, consumer safety, and professional care. The meeting has hosted by the FTC at the Constitution Center in Washington, DC, and was also available via webcast.
The “Now Hear This” workshop morning session was kicked off with opening remarks on the widespread incidence of hearing loss and importance of hearing healthcare by Tara Isa Koslov, JD, and Maureen Ohlhausen, JD, the acting director and acting chair of the FTC, respectively. John Eichwald, MA, of the Centers for Disease Control & Prevention (CDC) also provided an overview of a recent CDC study that shows 1 out of 4 US adults who report excellent-to-good hearing already have hearing damage (see April 2017 Hearing Review, p 42).
The afternoon session was kicked off by Eric Mann, MD, PhD, clinical deputy director of the Division of Ophthalmic & ENT Devices at the US Food & Drug Administration (FDA). Dr Mann provided a historical overview of the FDA’s medical device classification system, and also provided background on the recent decision to no longer enforce the requirement that individuals 18 and older receive a medical evaluation or sign a waiver prior to purchasing a hearing aid.
The rest of the meeting was divided into four panels that looked at topics being carefully considered by the FDA and FTC:
1) Innovations in Hearing Technology. Panel: Stavros Basseas, PhD, Sound World Solutions; Brent Edwards, PhD, Earlens Corporation; Jani A. Johnson, AuD, PhD, University of Memphis; Jan Metzdorff, Sonova US; Dianne Van Tasell, PhD, Bose Corporation; moderated by Karen Goldman, PhD., JD, and Daniel Wood, PhD, FTC.
2) Innovations in Hearing Health Delivery. Panel: Rupa Balachandran, PhD, University of the Pacific; Lucille Beck, PhD, Department of Veteran Affairs; Kim Cavitt, AuD, Audiology Resources Inc; Scott Davis, MBA, Sivantos, Inc. (formerly Siemens); Gary Swearingen, JD, Costco. Moderated by Daniel J. Gilman, JD, PhD, and David Schmidt, PhD, FTC.
3) The Costs and Benefits of Hearing Health Care Regulations. Panel: Bill Belt, Consumer Technology Association (CTA); Richard L. Cleland, JD, FTC; Rick Giles, ACA, BC-HIS, International Hearing Society; Frank Lin, MD, PhD, Johns Hopkins University; Ian Windmill, PhD, Cincinnati Children’s Hospital Medical Center and American Academy of Audiology. Moderated by Ellen Connelly, JD, and David Schmidt, PhD, FTC.
4) Informing Consumer Choice in Hearing Health Care. Panel: Stephanie Czuhajewski, Academy of Doctors of Audiology; Barbara Kelley, Hearing Loss Association of America; K.R. Liu, Doppler Labs; Lisa McGiffert, Consumers Union; Carole Rogin, MA, Hearing Industries Association and Better Hearing Institute. Moderated by: Gerald Stein, JD, and Daniel Wood, PhD, FTC.
Most panelists from the hearing industry emphasized the technological progress made in hearing aids, and how FDA regulatory requirements were not an impediment to innovation. However, while most of the presenters from the consumer electronics industry generally acknowledged the innovations in hearing aids, many also pointed out that the distinction between hearing aids and personal sound amplification products (PSAPs) and hearables is largely regulatory, not technological.
Hearing loss is an exceptionally complex disability in which customization and individualized treatment drives costs, noted most of the panelists. The proposed OTC classification will address cost and represents a potentially exciting opportunity to address the healthcare needs for a larger population of people, particularly for those who are only seeking solutions for specific listening situations. However, of greater concern is how OTC hearing aids would impact overall patient satisfaction and quality of care, as well as long-term consumer use of quality amplification products. Further, with the wide variety of technological solutions now just coming to the market—from self-screening and remote programming apps to teleaudiology—it’s impossible to predict what effects an OTC category (regulated or not) would have on consumers.
An outlier in the discussions was Bill Belt of the CTA. He implied that the current ANSI standards for hearing aids are inferior to minimal performance standards that CTA had developed for PSAP manufacturers, and current hearing aids would not pass these standards. He said that consumers don’t know or care about standards, and endorsed the idea that FDA should rely on the CTA voluntary standard and allow the organization to develop a logo akin to a “Good Housekeeping Seal of Approval.”
Another pivotal issue is what level of hearing impairment (ie, mild, mild-to-moderate, or mild-to-severe) an OTC device category might encompass. Several panelists noted the audiogram provides only a snapshot of peripheral hearing ability, and sheds little if any light on hearing in noise, cognitive function, etc. Research like that of Anu Sharma and panelist Frank Lin are yielding intriguing connections between hearing loss, cognition, cortical reorganization, co-morbidities, and quality of life.
State regulations and licensure also play a significant role in hearing healthcare, noted several presenters. There remains a patchwork of rules governing licensure requirements and fees, return policies, insurance, and other issues, adding complexity to hearing care. While government has done an admirable job in making sure children are covered by insurance, Medicare Part B does not provide for the aural rehabilitation that is a vital part of adult hearing care services. Although cost and accessibility remain large factors in the utilization of amplification, many panelists pointed out that the issues of stigma, lack of insurance coverage, and the inability to assess one’s own hearing disability still loom large.
The unbundling of pricing for hearing aid devices and hearing aid services was another topic of discussion. As HLAA’s Barbara Kelley pointed out, most consumers don’t understand it, nor do first-time users always recognize the service component as a fixed cost in the professional dispensing model. It was pointed out by her and other panelists that, while some consumers like and benefit from bundled pricing, others would prefer to pay only for those services they need and use. K.R. Lui of Doppler Labs, who is a younger person who has a hearing loss, also said that the hearing industry tends to concentrate their marketing and features on senior adults and their needs, not on people under age 39, further exacerbating the stigma issue.
Up next. The National Academies of Sciences, Engineering, and Medicine (NASEM) will hold its “Hearing Health Care Report Dissemination Meeting” on June 9. For details, visit: https://goo.gl/lAL4Mt