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National Academies of Sciences • Engineering • Medicine
Date: June 2, 2016
FOR IMMEDIATE RELEASE
Americans Need Easier Access, More Affordable Options for Hearing Health Care, Says New Report;
FDA Should Remove Regulation for Medical Evaluation to Purchase Hearing Aids and Create New Category of Over-the-Counter Hearing Devices
WASHINGTON – Hearing loss is a significant public health concern, and efforts should be made to provide adults with easier access to and more affordable options for hearing health care, especially for those in underserved and vulnerable populations, says a new report from the National Academies of Sciences, Engineering, and Medicine. The committee that carried out the study and wrote the report called for greater transparency and changes in the cost of hearing health care and expanded treatment options given the number of Americans who have hearing loss and the high cost of hearing health care. It recommended that the U.S. Food and Drug Administration remove the regulation requiring adults to have a medical evaluation or sign an evaluation waiver to purchase a hearing aid, as well as establish a new category of over-the-counter, wearable hearing devices – separate from hearing aids – that could assist adults with mild to moderate hearing loss. The report does not address surgical devices, such as cochlear implants, and related services.
An estimated 30 million Americans have hearing loss, but only about 14 percent to 33 percent of adults 50 years and older who might benefit from hearing aids use them. It has been reported that high costs, lack of insurance coverage, the stigma associated with wearing hearing aids, and limited awareness of available options are often barriers to accessing hearing health care – which includes services to diagnose and evaluate hearing loss, auditory rehabilitation, and hearing technologies. In addition, the average retail price for a pair of hearing aids in 2013 was $4,700, which reflected the cost of both the hearing aids and professional services. Individuals cover nearly all costs associated with hearing health care. Third-party payment for hearing health care is limited, and the majority of employers do not provide hearing health care insurance. Medicare Part B covers only diagnostic hearing tests, not other services or technologies, although some Medicare Advantage plans do.
“Hearing loss has been relegated to the sidelines of health care,” said committee chair Dan G. Blazer, J.P. Gibbons Professor of Psychiatry Emeritus at Duke University Medical Center in Durham, N.C. “For many people with hearing loss, trying to navigate the health care system to address their issues can be confusing and frustrating, and they can be left with no clear guidance on what will best fit their financial, health, social, and hearing needs. People who need hearing health care services and technologies should be at the center of their own care, with the option to make decisions about what is the most appropriate care for them.”
Weighing FDA’s requirement for a physician evaluation prior to obtaining hearing aids against the rareness of medical conditions that have hearing loss as a symptom, the incidence of hearing loss in adults, the widespread need for hearing health care, and the wide use of the medical evaluation waiver, the committee found no evidence that the evaluation or waiver of that evaluation provides any clinically meaningful benefit. The committee recommended removing this regulation to serve consumers’ best interests. Relatedly, people should be able to obtain their hearing health care records to enable them to be better informed about their health and change providers if they so choose.
Hearing technologies are rapidly changing, and lower cost technologies could potentially meet the demands of many adult consumers with mild to moderate hearing loss, the report says. Hearing aids – regulated by the FDA as Class 1 or Class 2 medical devices – are currently the primary set of devices used for the treatment of hearing loss, but people give numerous reasons for not using hearing aids, including their high cost, problems with fit and comfort, the stigma of looking old, and challenges with care and maintenance. Consumer electronic products termed “personal sound amplification products” are available and range in cost from less than $50 to more than $500 and may provide some or many of the technological features that hearing aids have. However, FDA guidelines note that these products cannot be marketed with the purpose of addressing hearing loss. Over-the-counter, wearable hearing devices could provide an additional easy-to-access and potentially less expensive option to meet the hearing needs of adults with mild or moderate hearing loss, and the committee recommended that FDA establish a new category of over-the-counter hearing devices.
Hearing health care professionals should improve transparency in their fee structure by clearly itemizing the prices of technologies and related professional services to enable consumers to make more informed decisions, the committee said. It recommended that the Centers for Medicare & Medicaid Services evaluate options, including possible statutory or regulatory changes, to provide coverage so that treating hearing loss is affordable for Medicare beneficiaries. Furthermore, employers, private health insurance plans, and Medicare Advantage plans should also evaluate options for providing their beneficiaries with affordable hearing health care insurance. In addition, CMS should examine pathways for enhancing access to assessment for and delivery of auditory rehabilitation services for Medicare beneficiaries, including reimbursement to audiologists for these services.
The committee found that the settings on many hearing aids can be adjusted only by hearing health care professionals who have an agreement with a given manufacturer or distributor to sell that brand of hearing aid, and many hearing health care professionals only sell one or a few different brands. As such, much of the direction of where to turn for help can be affected by hearing aid manufacturers and hearing health care professionals, which results in challenges for individuals who want to switch providers and for professionals who want to help patients seeking their assistance with a hearing device. The committee called for transparency of hearing aid programming, including the development and implementation of standards for hearing aid programming that allows any hearing health care professional to program device settings. It also recommended a requirement for point-of-sale information about hearing aids’ programming features and portability to be provided to consumers to enable them to make better informed purchasing decisions. Moreimproved compatibility and interoperability of hearing technologies with communications systems are also needed, because people with hearing loss frequently use hearing aids and hearing assistive technologies that couple with cell phones and a range of other communications systems.
The report also provides steps to take to support and manage hearing health and foster environments that maximize hearing and communication for everyone. People can reduce exposure to noise that is at high volume levels for extended periods of time and use hearing protection as appropriate; be aware of and recognize difficulties in hearing and communication and seek information and care through the range of available services and technologies; and when appropriate, seek out peer-support groups and other opportunities for those living with hearing loss. In addition, community-based organizations, advocacy organizations, employers, businesses, and government agencies should promote work and community environments that are conducive to effective communication and support individuals with hearing loss. Specifically, they should ensure compliance with the Americans with Disabilities Act and other related laws supporting those with disabilities and strive to exceed their minimum requirements as well as research and incorporate features into buildings and public spaces that improve hearing and communication.
The study was sponsored by the Centers for Disease Control and Prevention, U.S. Department of Defense, U.S. Department of Veterans Affairs, U.S. Food and Drug Administration, Hearing Loss Association of America, National Institute on Aging, and National Institute on Deafness and Other Communication Disorders. The National Academies of Sciences, Engineering, and Medicine are private, nonprofit institutions that provide independent, objective analysis and advice to the nation to solve complex problems and inform public policy decisions related to science, technology, and medicine. The Academies operate under an 1863 congressional charter to the National Academy of Sciences, signed by President Lincoln. For more information, visit http://national-academies.org. A roster follows.
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Action guide for individuals and families
Action guide for hearing health care providers
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THE NATIONAL ACADEMIES OF SCIENCES, ENGINEERING, AND MEDICINE
Health and Medicine Division
Board on Health Sciences Policy
Committee on Accessible and Affordable Hearing Health Care for Adults
Dan G. Blazer, M.D., M.P.H., Ph.D.* (chair)
J.P. Gibbons Professor of Psychiatry Emeritus
Duke University Medical Center
Brenda Battat, M.S.
Karen J. Cruickshanks, Ph.D.
Professor of Ophthalmology and Visual Sciences
Department of Population Health Sciences
School of Medicine and Public Health
University of Wisconsin
Jennifer E. DeVoe, M.D., D.Phil.*
Department of Family Medicine
Oregon Health & Science University
Judy R. Dubno, Ph.D.
Department of Otolaryngology
Medical University of South Carolina
Richard Ellenson, M.B.A.
Chief Executive Officer
Cerebral Palsy International Research Foundation
New York City
Barbara J. Evans, J.D., Ph.D.
George Butler Research Professor, and
Director, Center for Biotechnology and Law
University of Houston Law Center
Ellen J. Flannery, J.D.
Covington & Burling LLP
Darrell J. Gaskin, Ph.D.
Center for Health Disparities Solutions
Department of Health Policy and Management
Johns Hopkins Bloomberg School of Public Health
William R. Hazzard, M.D.*
Professor of Gerontology and Geriatric Medicine
J. Paul Sticht Center on Aging
Wake Forest School of Medicine
Frank R. Lin, M.D., Ph.D.
Associate Professor of Geriatric Medicine and of Otolaryngology
Johns Hopkins University School of Medicine
Bloomberg School of Public Health
Johns Hopkins Medical Institutions
Nicole Marrone, Ph.D., CCC-A
James S. & Dyan Pignatelli / Unisource Clinical Chair in Audiologic Rehabilitation for Adults
Department of Speech, Language, and Hearing Sciences
University of Arizona
José A. Pagán, Ph.D.
Center for Health Innovation
New York Academy of Medicine
New York City
Thomas Pippin, BC-HIS
Wisconsin Hearing Aids Inc.
Walnut Hill, Fla.
Katherine D. Seelman, Ph.D.
Associate Dean and Professor
School of Health and Rehabilitation Sciences
University of Pittsburgh
Debara L. Tucci, M.D., M.S., M.B. A.
Professor of Otolaryngology Head and Neck Surgery
Duke University Medical Center
David A. Zapala, Ph.D.
Associate Professor of Audiology
Department of Otolaryngology
Mayo Clinic Jacksonville
Sarah Domnitz, Ph.D.
Cathy T. Liverman, M.L.S.
*Member, National Academy of Medicine