By David H. Kirkwood
WASHINGTON, DC—As part of an ambitious, two-year study to identify ways to make hearing health care (HHC) for adults more accessible and affordable, a 13-member ad hoc committee of the Institute of Medicine (IOM) will hold a daylong open session on Monday, April 27.
IOM, the health arm of the National Academy of Sciences, is an independent, non-governmental, non-profit organization. It has no power to implement its recommendations. Rather, its stated aim is “to help those in government and the private sector make informed health decisions by providing evidence upon which they can rely.”
AGENDA FOR MEETING
During next week’s initial meeting of the Committee on Accessible and Affordable Hearing Health Care for Adults (the Committee), a dozen scheduled speakers, along with members of the public who choose to comment, will share their perspectives with the Committee on how to pursue its assigned task of reaching consensus on short- and long-term recommendations regarding accessible and affordable hearing care.
Three of the speakers will make presentations on the context of the study. They are Theresa Chisholm, PhD, chair of the Department of Communication Sciences & Disorders at the University of South Florida; Dianne Van Tasell, PhD, a prominent research audiologist who is senior scientist at Ear Machine LLC; and Meg Wallhagen, PhD, professor of gerontological nursing at the University of California, San Francisco and chairperson of the Hearing Loss Association of America (HLAA).
Representatives of seven of the organizations sponsoring the study will also offer their perspectives. Those sponsors are HLAA, the Department of Veterans Affairs, the National Institute on Deafness and other Communication Disorders (NIDCD), the Food and Drug Administration (FDA), the Department of Defense, the National Institute on Aging (NIA), and the Centers for Disease Control and Prevention.
The meeting, to be held at the Keck Center of the National Academies, at 500 5th St., NW, in Washington, will start at 10:30 am and conclude after a public comment period starting at 4:45 pm. IOM invites others who wish to comment on the subject to e-mail firstname.lastname@example.org or to visit the IOM web site.
SCOPE OF STUDY
The Institute of Medicine has laid out the scope of the Committee’s study, which will culminate in a consensus report due out by May 31, 2016. The IOM states:
“This study provides background on the importance of hearing to individual and societal health including issues such as isolation, social connectivity, well-being, and economic productivity.
“It will examine federal regulations for non-surgical hearing aid dispensing by asking if current regulations provide a clinically meaningful benefit to adults with hearing loss and what the required federal regulatory paradigm should be.
“The study will also address the affordability of non-surgical devices and services. It will look at how affordability can be improved, how current approaches can be used or modified to increase access, how new and innovative approaches (such as telehealth, mobile health, and team-based care) can be used to increase access and affordability, and will discuss challenges for select populations such as older adults and transitioning young adults.
“The committee will provide short- and long-term recommendations for solutions to these questions.”
While the IOM does not say so specifically, its statement suggests that the Committee will at least look at such controversial issues as the benefit (or lack thereof) of the required medical evaluation (unless waived by the consumer) before the purchase of a hearing aid; Medicare coverage of hearing aids; and, possibility, easing restrictions on the marketing of amplifying devices, often known as PSAPs (personal sound amplification products), that are not regulated by the FDA.
A PROTRACTED PROCESS
Next Monday’s meeting is the first gathering of the Committee on Accessible and Affordable Hearing Health Care for Adults. However, it is just one of several events along the way to the publication of a consensus report in May 2016.
The project got under way in January 2014 when IOM and the National Research Council held a workshop entitled Hearing Loss and Healthy Aging. What inspired them to tackle this topic?
Cathy Liverman and Sarah Domnitz, the study directors, noted that there had been “a lot of interest in the topic of topic of accessible and affordable health care, so this seemed like a god time to look at this issue.”
Among the 14 sponsors of the 2014 workshop were professional organizations (the American Academy of Audiology, the American Speech-Language-Hearing Association, the American Academy of Otolaryngology—Head and Neck Surgery, and the Academy of Doctors of Audiology); the Hearing Industries Association (HIA) and its trans-Atlantic counterpart, the European Hearing Instrument Manufacturers Association; three hearing care companies: Cochlear Americas, Med-El Corp., and HI HealthInnovations; HLAA; NIA; and NIDCD.
FEW ORIGINAL SPONSORS REMAIN
Of the original group of sponsors, only the last three listed above—HLAA, NIA, and NIDCD–are also sponsors of the April 27 meeting.
While it is not certain why the other 11 are not sponsoring the next meeting, the experience of one of them, HIA, suggests that IOM did not permit them to. HIA was a major sponsor of the 2014 workshop, paying $25,000, as did EHIMA, its sister organization. Other sponsors paid less.
Carole Rogin, president of the national trade association of manufacturers of hearing aids and related products, told this blog, “HIA was not contacted about this consensus study. When alerted to it, we asked IOM if we could name an industry expert to the panel. We were advised that no industry organizations would either serve on the panel or as sponsors, but that there would be a time in the process for industry to present to the panel. We were not given a rationale and I don’t want to speculate.”
Rogin added that Harvey Abrams, PhD, would represent HIA and the Better Hearing Institute (part of HIA) during the public comment period at the end of the April 27 meeting. She said that Abrams will “use the 3 minutes to outline the salient findings from MarkeTrak9 that relate to accessibility and affordability.”
This blog has learned that some professional organizations and industry companies and other organizations have complained that the hearing aid manufacturing sector and non-medical hearing care practitioners—which would appear to be especially well-positioned to play a key role in making hearing health care more accessible and affordable–have so little representation on the committee that will be writing the consensus report.
Asked about this criticism, Liverman and Domnitz noted that the IOM has strict rules regarding conflict of interest, which would preclude people from companies or others with a commercial interest in the findings of the Committee from serving on it. They also said that the Committee’s 13 members bring a wide range of expertise and independence to the study.
IOM COMMITTEE MEMBERS
The Committee on Accessible and Affordable Hearing Health Care for Adults that will be holding its first meeting on April 27 is chaired by Dan G. Blazer, MD, a professor of psychiatry emeritus and former dean of medical education at Duke University Medical Center and former president of the American Association of Geriatric Psychiatry. He is an expert on the epidemiology of late life psychiatric disorders, including depression, anxiety, and substance abuse.
The other members include two audiologists who work in academia: Nicole Marrone, PhD, the clinical chair in audiologic rehabilitation for adults at the University of Arizona, and Judy R. Dubno, PhD, a professor in the Department of Otolaryngology–Head and Neck Surgery at the Medical University of South Carolina in Charleston, whose research areas include how perception changes with age, hearing loss, hearing aids, and training.
Brenda Battat, whose 24 years at the Hearing Loss Association of America included 5 years as executive director, brings a consumer’s perspective to the Committee.
The committee includes three physicians: Frank R. Lin, MD, PhD, associate professor of otolaryngology, geriatric medicine, mental health, and epidemiology at the Johns Hopkins University School of Medicine and the Bloomberg School of Public Health, who is well known for his prolific research on hearing loss; William R. Hazzard, MD, professor of internal medicine at the Wake Forest School of Medicine and an authority on gerontology and geriatric medicine; and Debara L. Tucci, MD, MS, a professor of otolaryngology head and neck surgery, at Duke University, who worked as a clinical audiologist for 4 years before getting her medical degree.
Also on the committee are Karen J. Cruickshanks, PhD, an epidemiologist at the University of Wisconsin Medical School who has done research on the health problems of aging, including hearing loss; José A. Pagán, PhD, director of the Center for Health Innovation at the New York Academy of Medicine; independent consultant Richard Ellenson, CEO of the Cerebral Palsy International Research Foundation, and founder and CEO of two assistive technology companies; attorneys Barbara J. Evans, LLM, the director of the Center for Biotechnology and Law at the University of Houston Law Center and an expert in bioethics, and Ellen J. Flannery, co-chair of the law firm Covington & Burling LLP’s global food and drug law practice group; and Darrell J. Gaskin, PhD, deputy director of the Johns Hopkins Bloomberg School of Public Health and an expert in healthcare disparities, access to healthcare for vulnerable populations, and safety net hospitals.
The IOM Committee will hold two more information-gathering meetings, on June 30 and September 10, that will be open to the public . Liverman and Domnitz, the directors of this study, noted that there will be opportunities for public comment at those meetings as well as at the April 27 event. In addition, they said, “Written comments are welcome at any time. They can be submitted to email@example.com and will be added to the study’s public access file.”
When the committee’s consensus report finally emerges in May 2016, it will be up to Congress, government agencies, the private sector, and other interested parties to decide how to respond to its recommendations on accessible and affordable hearing care for adults.
Some IOM reports sink into obscurity, while others end up having a meaningful impact on health care. Liverman and Domnitz cited recent IOM reports on epilepsy, medical errors, and death and dying as among those that have proved influential.