The loss of hearing—be it gradual or acute, mild or severe, present since birth or acquired in older age—can have significant effects on one’s communication abilities, quality of life, social participation, and health. Despite this, many people with hearing loss do not seek or receive hearing health care. The reasons are numerous, complex, and often interconnected. For some, hearing health care is not affordable. For others, the appropriate services are difficult to access, or individuals do not know how or where to access them. Others may not want to deal with the stigma that they and society may associate with needing hearing health care and obtaining that care. Still others do not recognize they need hearing health care, as hearing loss is an invisible health condition that often worsens gradually over time. Finally, others do not believe that anything can be done to help them or they feel that the perceived benefit or value of intervention will not be significant enough to overcome the perceived barriers to access.
In the United States, an estimated 30 million individuals (12.7 percent of Americans ages 12 years or older) have hearing loss. Globally, hearing loss has been identified as the fifth leading cause of years lived with disability. Age-related hearing loss is of increasing public health concern as the older adult population grows. The prevalence of hearing loss rises steeply with age, from approximately 3 percent among adults 20 to 29 years of age to an estimated 45 percent among the 70- to 74-year age group and more than 80 percent in the 85-years-and-older age group. The unmet need for hearing health care is high. Estimates of hearing aid use are that 67 to 86 percent of adults who may benefit from hearing aids do not use them.
This study focuses on improving the accessibility and affordability of hearing health care for adults of all ages. This report uses the term “hearing health care” to encompass the range of services (e.g., diagnosis and evaluation, auditory rehabilitation) and hearing technologies (hearing aids and hearing assistive technologies) relevant to hearing loss. Hearing health care is viewed through the social-ecological model that emphasizes the multiple levels of support and action needed throughout society to promote hearing and communication and reduce hearing loss and its effects. The report does not address surgical devices such as cochlear implants.
To address the statement of task, the National Academies of Sciences, Engineering, and Medicine appointed a 17-member committee with expertise in hearing health care services, audiology, otology, hearing loss advocacy, primary care, geriatrics, health economics, technology policy and law, and epidemiology. The study was sponsored by (alphabetically) the Centers for Disease Control and Prevention, the Department of Defense, the Department of Veterans Affairs, the Food and Drug Administration, the Hearing Loss Association of America, the National Institute on Aging, and the National Institute on Deafness and Other Communication Disorders.
In examining the complex issues around hearing loss in adults and hearing health care, the committee developed a set of principles that helped shape its work:
Hearing loss may develop at any time during the life course. The onset can be sudden or gradual, and it can affect one or both ears. Hearing loss can result from a variety of causes (e.g., trauma, infection, genetic syndromes, aging, excessive noise exposure), and the pathological changes can occur in one or more regions of the auditory system. Although some hearing loss can be temporary or treatable using medical or surgical methods, most hearing loss in adults is permanent and managed as a chronic condition. Presbycusis, or age-related hearing loss, has been documented in many mammalian species and is characterized in humans by increased hearing thresholds, impaired processing of higher-level sounds (including reduced
frequency and temporal resolution), and difficulty understanding speech, especially in noisy or complex listening environments.
Much remains to be learned about the extent and impact of hearing loss, particularly from a population perspective. The effects of hearing loss on communication and, as a consequence, social interactions and functional abilities have serious public health implications for adults of all ages. Among older adults—a growing demographic in the United States and globally—hearing loss is a common, chronic disability that escalates especially in those over 80 years of age. A link between hearing ability and cognitive function and dementia has long been recognized but has only recently begun to be systematically studied. Cross-sectional studies have examined the association of hearing loss with falls, declines in physical functioning, and hospitalization, but population-based longitudinal studies are lacking. The potential economic impacts of hearing loss, including reduced income and increases in unemployment or underemployment, have been modeled, but population-based longitudinal data are needed.
Goal 1: Improve Population-Based Information on Hearing Loss and Hearing Health Care
Recommendation 1: The National Institutes of Health, the Centers for Disease Control and Prevention, the Patient-Centered Outcomes Research Institute, the Department of Defense, the Department of Veterans Affairs, state public health agencies, and other relevant government agencies, as well as nonprofit organizations, hearing health care professional associations, academic institutions, and researchers, should strengthen efforts to collect, analyze, and disseminate prospective population-based data on hearing loss in adults and the effects of hearing loss and its treatment on patient outcomes.
Specifically,
advanced biostatistics, and health services and health economics research methods.
Although it is widely recognized that hearing aids and hearing assistive technologies can be key components to improving hearing and communication abilities, the critical role that hearing-related services can play in hearing health care is often overlooked. These services include the systematic and comprehensive assessment of an individual’s hearing and communication difficulties (e.g., at home, in the workplace, participating in the community), the diagnosis of underlying medical conditions, evaluation of the individual’s hearing loss and treatment needs, auditory rehabilitation, and counseling and other services that help the individual to maximize his or her hearing and communication abilities.
Navigating the hearing health care system can be confusing. Entry into the hearing health care system can occur through multiple pathways (audiologists, hearing instrument specialists, otolaryngologists, primary care providers, self service, and others). Consumers can be left with no clear guidance on what will best fit their financial, health, social, and hearing needs. When consumers are left to traverse this complex system, they can find the process and outcomes to be frustrating and unsatisfactory. For the most part, little is known about the relative effectiveness or quality of these services. Guidelines, standards, and metrics must be regularly reviewed and updated to ensure that the most recent evidence is translated into best practices for hearing health care professionals and is disseminated to people with hearing loss and their families.
Goal 2: Develop and Promote Measures to Assess and Improve Quality of Hearing Health Care Services
Recommendation 2: The Centers for Medicare & Medicaid Services, the National Institutes of Health, the Department of Defense, the Department of Veterans Affairs, other relevant federal agencies, hearing health care professional associations and providers, advocacy organizations, health care quality improvement organizations, health insurance companies, and health systems should collaborate to
Although the hearing health care system is intended to help individuals maximize their hearing and communication abilities, manage their health and well-being, and find ways to compensate for their hearing loss through the use of services and technologies, many individuals report dissatisfaction with the U.S. hearing health care system. Multiple barriers prevent the system from being person centered and person directed. Instead, much of the direction lies in the hands of hearing aid manufacturers and hearing health care professionals, which results in challenges for individuals who want to switch providers, and in challenges for professionals trying to help individuals who seek their assistance with a hearing device that can only be programmed by certain providers. Individuals 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. In examining the Food and Drug Administration’s (FDA’s) requirements for physician evaluation prior to obtaining hearing aids, the committee finds no evidence that the required medical evaluation or waiver of that evaluation provides any clinically meaningful benefit. In weighing the rareness of the medical conditions, the incidence of hearing loss in adults, the widespread need for hearing health care, and the wide use of the medical waiver, the committee recommends removing this regulation to serve consumers’ best interests. Relatedly, individuals should be able to obtain their hearing health care records, including audiogram and hearing aid programming history, from their hearing health care professional to enable them to be better informed about their health and change providers if they so choose.
Goal 3: Remove FDA Regulation for Medical Evaluation or Waiver to Purchase a Hearing Aid
Recommendation 3: The Food and Drug Administration should remove the regulation that an adult seeking hearing aids be required to first have a medical evaluation or sign a waiver of that evaluation and should ensure consumers receive information about the medical conditions that could cause hearing loss through continued inclusion of that information in hearing aid user instructional brochures.
Goal 4: Empower Consumers and Patients in Their Use of Hearing Health Care
Recommendation 4: Hearing health care professionals, professional associations, advocacy organizations, and relevant government agencies such as the Office for Civil Rights at the Department of Health and Human Services should ensure patients are aware of, and understand how to exercise, their rights of access to information about themselves
under the Health Insurance Portability and Accountability Act Privacy Rule (45 C.F.R. Section 164.524), including their audiograms and hearing aid programming history.
Similar to many other sectors of the U.S. health care system, hearing health care does not reach all who need it. Residents of rural and low-income urban areas are at a particular disadvantage in accessing care. Furthermore, the minimal diversity in the hearing health care workforce does not mirror the wide diversity in the population of adults this workforce serves. With the high incidence of hearing loss in the adult population and the low utilization of the hearing health care system, efforts should be made to provide easier access for all, especially those for whom socioeconomic barriers exist.
Goal 5: Improve Access to Hearing Health Care for Underserved and Vulnerable Populations
Recommendation 5: The Health Resources & Services Administration, state health departments, advocacy organizations, and hearing health care professional schools and associations should
Effective communication is key both for emotional well-being and for participating in making decisions about one’s own health care plan. Hearing is often overlooked in adult medical and wellness visits because of the large number of other health conditions and concerns that must be assessed or, in the case of older adults, because of the assumption that hearing loss is typical and cannot be helped. However, increasing evidence shows that hearing is important for health, and the potential for miscommunication with health care providers due to hearing loss demonstrates the importance of paying attention to hearing ability during medical and wellness visits. Furthermore, health care providers should be aware of the importance of hearing and the need to emphasize, rather than dismiss, hearing concerns during health care visits.
Goal 6: Promote Hearing Health Care in Wellness and Medical Visits
Recommendation 6: Public health agencies (including the Centers for Disease Control and Prevention and state health departments), health care systems (including those of the Department of Defense and the Department of Veterans Affairs), health care professional schools and associations, advocacy organizations, health care providers, and individuals and their families should promote hearing health in regular medical and wellness visits (including the Medicare Annual Wellness Visit).
Specifically,
The hearing technology landscape is ever-evolving and encompasses a wide range of products from traditional hearing aids regulated as medical devices to consumer-technology products and hearing assistive technologies. The broad spectrum of types and severity of hearing loss necessitates a wide range of technologies to meet each individual’s needs while also meeting requirements for safety and interoperability with other technologies (e.g., cell phones, televisions, and emergency alert systems).
Hearing aids, currently the primary set of devices used for the treatment of hearing loss, are regulated by FDA as Class I or Class II medical devices. In the United States, as in many countries, hearing aid use is low compared to the high prevalence of hearing loss. Estimates of hearing aid use are that 67 to 86 percent of adults who might benefit from hearing aids do not use them. Among the numerous reasons given by individuals for not using hearing aids are the high cost; a lack of effectiveness; challenges with fit, comfort, and use; side effects such as rashes or itching; stigma; challenges with care and maintenance (e.g., changing batteries); and not recognizing that there is a need for hearing assistance.
FDA has established regulations for hearing aids, including quality system regulation requirements, mandatory labeling, and pre-purchase medi-
cal evaluation (or a documented waiver). These regulations, along with a number of state regulations, have largely restricted the availability of hearing aids to being mainly dispensed through medical, audiology, or hearing instrument specialist venues. To date, proposals for over-the-counter (OTC) or direct-to-consumer hearing aids have not been approved. Consumer technology products, including personal sound amplification products (PSAPs), have been developed. PSAPs are not considered medical devices, and FDA guidance documents specify that PSAPs cannot be marketed in the United States as products intended for improving hearing loss.
The committee identified the need for FDA to create a category of OTC wearable hearing devices intended for use by individuals with mild or moderate hearing loss. These devices would need to meet specific safety and quality standards and labeling specifications. This regulatory approach would be similar to FDA’s regulatory approach of creating separate device classification regulations for prescription eyeglasses and reading glasses (a parallel drawn here specifically to the regulatory approach and not the performance of the devices). A category of OTC wearable hearing devices could provide an additional, easy-to-access option with the potential for lower cost to meet the hearing needs of adults with mild or moderate hearing loss.
Individuals with hearing loss frequently use hearing aids with telecoils or other hearing assistive technologies that couple with cell phones and a range of other communications systems. Efforts are needed to standardize the interfaces and connection of hearing aids, hearing assistive technologies, and OTC wearable hearing devices with other types of technologies and communications systems.
Goal 7: Implement a New FDA Device Category for Over-the-Counter Wearable Hearing Devices
Recommendation 7: The Food and Drug Administration (FDA) should establish a new category of over-the-counter (OTC) wearable hearing devices. This device classification would be separate from “hearing aids.” OTC wearable hearing devices would be defined as wearable, OTC devices that can assist adults with mild to moderate hearing loss.
These devices would
and preempt potential future state laws and regulations seeking to limit OTC access;
To further clarify the types of hearing technologies and their oversight and regulation:
Currently, the settings on many hearing aids can only be adjusted by hearing health care professionals who have an agreement with a given manufacturer or distributor to sell that brand of hearing aid. Furthermore, many hearing health care professionals only sell one or a few different brands of hearing aids. A consumer who purchases a hearing aid from one hearing health care professional may find that the manufacturer or distributor has restricted access for adjusting the settings, and thus, the consumer may have to seek all additional programming services from the same distributor that originally sold him or her the product. An open platform approach would provide consumers with greater portability in their hearing health care including increasing the options for choosing their hearing health care professional. Consumers should be notified prior to the point of sale regarding the portability of hearing aid programming.
Greater public awareness and user-friendly instructions about the availability, portability, connectivity, and use of hearing aids and hearing assistive technologies, as well as comparable details on product features, are needed to enable informed decision making.
Goal 8: Improve the Compatibility and Interoperability of Hearing Technologies with Communications Systems and the Transparency of Hearing Aid Programming
Recommendation 8: The Federal Communications Commission, the Federal Trade Commission, the Food and Drug Administration, the National Institutes of Health, and other relevant federal agencies; the American National Standards Institute and other standards-setting organizations; manufacturers; and industry, professional, and consumer advocacy organizations should
ity of hearing aids in order to enable more informed purchasing decisions.
For many people cost can be a key factor in making health care decisions; for some people cost can be the driving factor, including determining whether to forego the care entirely. The cost of hearing health care includes the cost of services and technologies, and these costs may be incurred multiple times over a period of many years in order to maintain and replace hearing aids and other technologies, to continue to monitor hearing status, and to retain the benefit from auditory rehabilitation and other services. The average retail price for a pair of hearing aids in 2013 was $4,700 (bundled price including the costs of services).
In the hearing health care system that serves adults, nearly all costs are covered by the individual. Third-party payment for hearing health care is limited and many employers do not offer hearing health care insurance options. Currently Medicare Part B covers only diagnostic hearing tests; it does not cover other services or technologies, although some Medicare Advantage plans do. Only some state Medicaid programs offer hearing health care benefits, and several of those that do offer it have strict limitations on eligibility. Vocational rehabilitation programs offer a tremendous benefit for those with hearing loss who are seeking employment, but many individuals are not even aware that this program exists. Furthermore, young adults who have had hearing loss since childhood can face unique financial challenges in transitioning from programs that provided them with hearing aids and services as children and youth to receiving limited, if any, benefits as adults. Given the high numbers of Americans who have hearing loss and the high cost of hearing health care, changes to the cost of hearing health care are needed.
Goal 9: Improve Affordability of Hearing Health Care
Recommendation 9: The Centers for Medicare & Medicaid Services (CMS), other relevant federal agencies, state Medicaid agencies, health insurance companies, employers, hearing health care providers, and vocational rehabilitation service agencies should improve hearing health care affordability for consumers by taking the following actions:
There are many unknowns in the hearing health care system. The comparative effectiveness of different care delivery models, the health and economic benefits of identifying and treating adult hearing loss early, and the potential for new technologies to disrupt and improve care are just a few of the areas where more research and evaluation are needed. An understanding of these issues will be necessary to continue making strides forward in improving accessibility to and affordability of hearing health care for all.
Goal 10: Evaluate and Implement Innovative Models of Hearing Health Care to Improve Access, Quality, and Affordability
Recommendation 10: The Centers for Medicare & Medicaid Services, the Patient-Centered Outcomes Research Institute, the Agency for Healthcare Research and Quality, the National Institutes of Health, the Centers for Disease Control and Prevention, the Health Resources & Services Administration, the Department of Defense, the Department of Veterans Affairs, researchers, and health care systems should prioritize and fund demonstration projects and studies, including randomized controlled trials, to improve the evidence base for current and innovative payment and delivery models for treating hearing loss.
Specifically,
Hearing plays a vital role in how individuals experience, interact with, and relate to the people and environment around them. Hearing is sometimes referred to as the “social sense” because of its function in developing and maintaining intimate relationships and social connections with family, friends, coworkers, and acquaintances. Supporting individuals with hearing loss requires adaptable solutions that span society—not just solutions within the context of a medical model that revolves around delivery of care and services in a health care setting. These solutions should reduce stigma and negative media perceptions and ensure that consumers understand their hearing test results and have the information they need to compare devices and products and to determine pathways to accessing hearing health care services.
People with hearing loss can experience a variety of challenges in terms of employment and the workplace, including obstacles related to finding employment, career development, promotion and career advancement, equitable compensation, and the balance between job demands and a sense of control and confidence in managing work-related situations. The Americans with Disabilities Act and related laws have provisions that improve access to hearing assistance in some settings, but it is not always adequate, and technology in public venues is not always functional.
For people with hearing loss, the acoustics of the places where they live, work, learn, and socialize, the availability of hearing aids and hearing assistive technologies, and the ability to connect to other communications-enhancing systems may mean the difference between participating in and engaging with their community and feeling isolated. Raising public awareness of hearing health and of the range of options to facilitate communication is key and will require the collaboration of many groups. In addition, individuals, family members, employers, and communities can take actions to maximize hearing and facilitate communication for the benefit of all.
Goal 11: Improve Publicly Available Information on Hearing Health
Recommendation 11: The National Institutes of Health, the Centers for Disease Control and Prevention, the Food and Drug Administration, the Department of Defense, the Department of Veterans Affairs, the Administration for Community Living, state public health agencies, other relevant government agencies, advocacy organizations, hearing health care professional associations, hearing technology manufacturers, hearing health care professionals, and media organizations should improve public information on hearing health and hearing-related technologies and services and promote public awareness about hearing and hearing health care.
Specifically,
Goal 12: Promote Individual, Employer, Private-Sector, and Community-Based Actions to Support and Manage Hearing Health and Effective Communication
Recommendation 12: Individuals, families, community-based organizations, advocacy organizations, employers, private-sector businesses, and government agencies (local, state, federal) should take actions to support and manage hearing health and foster environments that maximize hearing and communication for all individuals.
With the positive changes in patient engagement and empowerment occurring throughout the health care system and with the rapid pace of evolution in technology, it is an opportune time to explore and implement changes in the way hearing itself is viewed and the way hearing health care as a whole is delivered, valued, and evaluated. With the benefit of key institutional, technological, and regulatory changes to improve access and affordability, hearing health care is poised to undergo advances that will help individuals with hearing loss and their families find and fully utilize the appropriate, affordable, and high-quality services, technologies, and support they need. Fully developing the array of options for adults of all ages and with all levels of hearing loss (mild, moderate, severe, and pro-
found) requires that hearing loss be recognized as a public health concern that demands multidisciplinary and collaborative efforts by all stakeholders working together with the common goal to improve hearing and communication abilities for individuals and across the population (see Box S-1).