Hearing loss is a significant public health concern. According to a new report from the National Academies of Sciences, Engineering, and Medicine, efforts should be made to provide adults with easier access to and more affordable options for hearing-related health care, especially for those in underserved and vulnerable populations.
The committee that carried out the study and wrote the report called for greater transparency and changes in hearing-related healthcare costs and expanded treatment options given the number of Americans who have hearing loss.
The report recommends that the U.S. Food and Drug Administration (FDA) remove the regulation requiring adults to either have a medical evaluation or sign an evaluation waiver to purchase a hearing aid. It also calls for the establishment of 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% to 33% 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 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 those costs: third-party payment for care is limited, and the majority of employers do not provide insurance for hearing-related issues. 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 healthcare," 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 healthcare 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 healthcare 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."
The committee weighed the 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-related care and the wide use of the medical evaluation waiver. It found no evidence that the evaluation or its waiver provide any clinically meaningful benefit. Furthermore, the committee feels people should be able to obtain their hearing 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.
Healthcare professionals should improve transparency in their fee structure by clearly itemizing the prices of technologies and related professional services to enable consumers to make 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 healthcare 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 healthcare professionals who have an agreement with a given manufacturer or distributor to sell that brand of hearing aid, and many hearing healthcare 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 healthcare professionals, which results in challenges for individuals who want to switch providers and for professionals who want to help patients.
The committee called for transparency of hearing aid programming, including the development and implementation of standards for hearing aid programming that allows healthcare professionals 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. More improved 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:
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.