On Thursday, June 2, the Committee on Accessible and Affordable Hearing Health Care for Adults, a part of the National Academies of Sciences, Engineering, and Medicine (formerly known as the Institute of Medicine or IOM), released its final report containing the recommendations it believes will enable consumers with hearing loss to find and use more appropriate, affordable, and high-quality services, technologies, and support. The report, Hearing Health Care for Adults: Priorities for Improving Access and Affordability, contains 12 recommendations, many of which, if eventually made a reality, could profoundly change hearing healthcare in the United States. Notable for hearing care professionals are recommendations for:
- The revocation of the so-called “waiver system” which requires consumers first to see a physician or sign a waiver prior to obtaining a hearing aid;
- The establishment of an over-the-counter (OTC) class of hearing aids;
- The unbundling of costs for hearing aids and hearing healthcare services for greater price transparency;
- Greater “interoperability,” including hearing aids that don’t lock out programming capabilities for other providers or consumers;
- Portability of hearing-related records, including consumer knowledge about their rights to retain their audiograms and hearing aid programming data, and
- CMS to review of Medicare coverage for audiologic services, as well as the revisiting the Medicare coverage for hearing aids and related services currently excluded by the Social Security Act of 1965 (it would take Congress to amend the Act).
Dr Dan G. Blazer
The 1-hour meeting led by Committee Chair Dr Dan G. Blazer of the Duke University Medical School and Jennifer Walsh of the Office of News and Public Information, revealed what the Committee views as a pressing need for more cohesion between all entities involved in the hearing healthcare system and general healthcare, a greater depth of service and technology options for consumers with hearing loss, and more support for research and public information about hearing loss and its treatment.
The Committee’s final 12 recommendations, which are not listed in order of priority, are:
- Improve population-based information on hearing loss and hearing health care. All stakeholders, government and educational organizations and public health agencies 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.
- Develop and promote best practices and measures to assess and improve quality of hearing health care services. A concerted effort to align and promote best practices and core competencies across the continuum of hearing health care, and implement mechanisms to ensure widespread adherence should be undertaken by the Centers for Medicare & Medicaid Services (CMS), the National Institutes of Health (NIH), the Department of Defense (DoD), the Department of Veterans Affairs (VA), hearing care stakeholders and their professional organizations, advocacy groups, health insurance companies, and health systems. These organizations should also collaborate in research, development, and implementation of a set of quality metrics and measures to evaluate hearing healthcare services with the end goal of improving hearing- and communication-focused patient outcomes.
- Remove FDA’s regulation for medical evaluation or waiver of that evaluation prior to hearing aid purchase. The Food and Drug Administration (FDA) 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 medical conditions that could cause hearing loss through continued inclusion of that material in hearing aid user instructional brochures.
- Empower consumers and patients in their use of hearing health care. The Committee says there is a need for greater transparency and access rights by consumers to their hearing-related information, including audiograms and hearing aid programming history. Hearing health care professionals, professional associations, advocacy organizations, and relevant governmental 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 (HIPAA, 45 CFR Section 164.524).
- Improve access to hearing healthcare for underserved and vulnerable populations. Government and hearing care stakeholders should encourage more diversity in all sectors of the hearing healthcare workforce and strive to reach more underserved communities, including rural and underserved areas using mechanisms such as telehealth, outreach clinics, and community health workers. Additionally, the Committee recommended promotion of academic hearing-related programs, including incentives such as tuition assistance, to increase diversity in all sectors of the hearing health care workforce and to promote the training of cultural competency in the hearing healthcare workforce and incentivize practice in underserved communities.
- Promote hearing healthcare in wellness and medical visits for those with concerns about their hearing. Hearing health should be promoted in regular medical and wellness visits (including the Medicare Annual Wellness Visit). Specifically, doctors should use patient visits to assess and discuss potential hearing difficulties that could affect doctor-patient communication and overall patient well-being, encourage individuals and their family members and caregivers to discuss hearing concerns, raise awareness among older adults about age-related hearing loss, and encourage referral when appropriate. Development and dissemination of core competencies, curricula, and continuing education opportunities focused on hearing health care should be particularly directed at primary care providers. This could be coordinated through public health agencies, healthcare systems (including DoD and VA), healthcare professional schools and associations, advocacy organizations, healthcare providers, and individuals with hearing loss and their families.
- Implement a new FDA device category for over-the-counter (OTC) wearable hearing devices. The FDA should establish a new category of 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.
- Improve the compatibility and interoperability of hearing technologies with communications systems and the transparency of hearing aid programming. Standards should be developed that ensure hearing aids and OTC wearable hearing devices are compatible and interoperable with other technologies and communications systems. Public awareness and consumer-friendly information on the availability, connectivity, and use of hearing aids and hearing assistive technologies should also be enhanced. Similarly, standards should be developed for an open-platform approach for hearing aid programming that allows any hearing care professional (or, as evolving technology allows, the device owner) to program the device settings. Finally, there should also exist point-of-sale information about the programming features and programming portability of hearing aids in order to enable more informed purchasing decisions. These efforts could be spearheaded by the Federal Communications Commission (FCC), Federal Trade Commission (FTC), FDA, NIH, and other relevant federal agencies in coordination with the American National Standards Institute (ANSI) and other standards-setting organizations, manufacturers, as well as industry, professional, and consumer advocacy organizations.
- Improve affordability of hearing health care by actions across federal (including Medicare and Medicaid), state, and private sectors. Transparency in the fee structure of hearing care professionals should be achieved by clearly itemizing (unbundling) the prices of technologies and related professional services to enable consumers to make more informed decisions. CMS should evaluate options, including possible statutory or regulatory changes, to provide coverage so that treating hearing loss (eg, assessment, services, and technologies, including hearing aids) is affordable for Medicare beneficiaries. CMS should also examine pathways for enhancing access to assessment for and delivery of auditory rehabilitation services for Medicare beneficiaries, including reimbursement to audiologists for these services. Similarly, state Medicaid agencies should evaluate options for providing coverage for treating hearing loss (eg, assessment, services, and hearing aids and hearing assistive technologies as needed) for adult beneficiaries. Hearing care professionals and their professional organizations should be more active in turning to vocational rehabilitation agencies to raise public awareness about their services that enable adults to participate in the workforce, and they should collaborate with other programs in their respective state to raise this awareness. Employers, private health insurance plans, and Medicare Advantage plans should evaluate options for providing their beneficiaries with affordable hearing health care insurance coverage. All these actions should be addressed by CMS, other relevant federal agencies, state Medicaid agencies, health insurance companies, employers, and hearing healthcare providers, as well as vocational rehabilitation service agencies.
- Evaluate and implement innovative models of hearing healthcare to improve access, quality, and affordability. Funding needs to be obtained for studies and demonstration projects—including randomized controlled trials—to improve the evidence base for current and innovative payment and delivery models for treating hearing loss. This should be undertaken by CMS, the Patient-Centered Outcomes Research Institute, the Agency for Healthcare Research and Quality, the NIH, CDC, the Health Resources & Services Administration, DoD and VA, researchers, and healthcare systems.
- Improve publicly available information on hearing health. There should be a wide-based promotion of public information on hearing health and hearing-related technologies and services, as well as promotion of public awareness about hearing and hearing health care. In particular, this should be undertaken by NIH, the CDC, FDA, DoD and VA, the Administration for Community Living, state public health agencies, and other relevant government agencies, advocacy organizations, hearing healthcare professional associations, hearing technology manufacturers, hearing healthcare professionals, and media organizations.
- Promote individual, employer, private sector, and community-based actions to support and manage hearing health and effective communication. Action should be taken to support and manage hearing health and foster environments that maximize hearing and communication for all individuals.
Dr Blazer also highlighted three general findings that significantly shaped the above recommendations by the Committee:
- Hearing is vital to communication, health, function, and quality of life. Individuals need to be alert to their hearing health, as hearing loss can range from mild to profound and tends to increase with age, onset can be gradual, and each individual’s hearing needs are unique.
- Hearing healthcare involves a wide range of services and technologies with ever-expanding and evolving options; however, many people do not have access to these options or cannot afford them.
- Hearing loss is a public health and societal concern; engagement and action are needed across the spectrum of relevant stakeholders, including individuals and families, professionals, nonprofit organizations, industries, government, and the health care community.
Questions and answers. After the findings and recommendations were presented, questions were fielded by representatives from the Committee, including Dr Blazer, audiologist Nicole Marrone of the University of Arizona, Brenda Battat, an independent consultant and longtime consumer advocacy leader, researcher and physician Dr Frank R. Lin of Johns Hopkins University, and legal counsel Ellyn J. Flannery of Covington and Burling LLP.
The Committee’s recommendations are similar to the October 2015 recommendations in the “letter report” of the President’s Council of Advisors on Science and Technology (PCAST). When asked to compare the two reports, Dr Blazer explained that the Committee began its deliberations prior to any knowledge of the work of PCAST, and thus their report runs parallel to that of PCAST. “You will find there are many similarities,” said Blazer, “They are not identical…We felt that our report needed to be independent.” Flannery explained that the Committee’s report is, in some ways, more specific in its recommendations for an OTC class of wearable hearing device. “In particular, the report mentions that we see it different from a hearing aid—a separate category—in part to address the state law issues that could interfere with OTC [device] availability. And we have some very specific suggestions for FDA with regard to performance standards, labeling for the consumers, and also trying to tailor the requirements, such as good manufacturing practices, so as not to be overly burdensome [so] that manufacturers would want to participate in an OTC device category and that consumers would be able to have accessibility to it.”
Audiologist Alicia Spoor, representing the Academy of Doctors of Audiology (ADA), asked if the Committee had considered any recommendation for a hearing evaluation prior to the purchase of a device. Blazer first made it clear that, for hearing aids currently defined as medical devices by the FDA, the Committee did not make a distinction between working with audiologist or hearing aid specialist, and that was not part of the Committee’s considerations. In terms of the OTC devices themselves, he said “the fact that this is over-the-counter suggests there are individuals who would be using these who would not seek professional care. At the same, we did not suggest within the report that individuals who purchased the OTC devices would not be able to benefit from an audiologist or other person involved [in terms of] consultation regarding their hearing. The whole approach we took was one of opening up possibilities and opening up options. Some people may…be able to purchase an OTC device and that works fine for them for awhile. And we felt that option needs to be there. But there will be other individuals who need to be in consultation with a professional.”
“One of the sub-recommendations with regard to the OTC category was to have an option to include accessory tests for self-assessment of mild-to-moderate hearing loss for purposes of selecting an OTC hearing device,” added Marrone, an audiologist. Blazer emphasized that “there is no place in the report that would suggest that hearing healthcare professionals across the spectrum are less needed. We see the increased value of these individuals. And that’s one of the things that our report emphasizes in terms of making certain the public understands what value these professionals bring to individuals for hearing healthcare.”
Amplifon President Heinz Ruch asked what evidence the Committee used for determining the need for or efficacy of an OTC wearable category. Other recent findings and articles about divergent European hearing care systems suggest lower-quality non-professionally dispensed products in some countries, like Japan, may be having a negative impact on hearing health. “Obviously, we don’t have an evidence-based [conclusion]; this category doesn’t exist now, so we don’t have an evidence base for the category,” said Dr Blazer. “We had more than one charge with this Committee, and one was to look into possibilities for what could be done to improve, in a safe way, affordability and accessibility to hearing health technologies…It’s probably worth saying that, if we see this go through the FDA and this device category is approved, there definitely will need to be studies on the effectiveness of these [OTC] devices. There will also need to be, we think, more studies on the effectiveness and the barriers to the effectiveness of hearing aids. There is not as much data there as we need…Definitely, there needs to be more evidence, but we feel like there needs to be a move forward to opening up options now and not waiting for evidence for devices [not available yet]…”
Spoor also asked what next steps are planned for the report and its dissemination. “Our work is completed in terms of the report itself,” said Blazer. “Our Committee is disbanded and our charge doesn’t go beyond the report itself…We very much want to see this report get legs and move in many different directions. We are willing to brief various organizations [and] briefed the sponsors…We are going to be briefing the Hearing Loss Association of America in about 3 weeks at their annual convention. There are going to be many opportunities to get the word out in terms of the contents of the report and recommendations we’re making. We feel that, if CMS asks, or we can find a way to brief them [on the report] we will definitely find a way to do that. I think what’s important to recognize is that this has now…moved beyond the National Academies and has moved into the public. We’ve made our recommendations and really want to see the different actors that we’ve listed in this report to [address these issues]. Equally important, we feel these actors need to be [working] together in coordination. And so we’re hoping they’ll be talking with one another. They have much in common. They’re being challenged by the very same issues. The more they’re communicating with one another, the better we’re going to be.”
Karl Strom is editor in chief of The Hearing Review.
Are you talking about this quote?
“Obviously, we don’t have an evidence-based [conclusion]; this category doesn’t exist now, so we don’t have an evidence base for the category,” said Dr Blazer.
If so, it gave the impression that the lack of data was not important enough to keep them from recommending action (they didn’t recommend data collection). Curious.
It was my understanding that the FDA did testing and research on the effectiveness of a product prior to approving it, not after it is already on the market. In Dr. Blazer’s answer to Heinz Ruch, he suggests fast tracking FDA approval for these devices to get them out to the consumer ASAP. Mr. Ruch related recent studies of ineffectiveness of OTC devices and even negative impact on hearing healthcare in Europe and Japan, but that didn’t seem to deter Dr. Blazer from putting the cart before the horse.
I am so impressed by this report. What the industry needs is some courage to make more options available and try new things in the interest of the consumers.
To unbundle hearing aid costs would be paramount to what is occurring in the medical field, where Providers must “herd” people through their doors in order to be profitable. Unfortunately, most people advocating reduced pricing in hearing services have never know what it’s like to own a business, or deal with competition from large corporations bent on destroying good service to he hearing impaired. What we need is the same type of cost-cutting in the dental industry. Good luck with that.
While it is laudable that we need to reach out to every person that needs hearing help, the fact that the genesis for most hearing losses begins with ear infections. The sensorineural component of such infections manifests a few years later, starting a permanent trend in the irreversible progression of hearing loss. Therefore the ENT specialist must continue to remain first in the chain of events that could lead to a hearing aid fitting. The proposals listed above are ridiculous. Hearing loss, unlike reduced vision has the main element of cognition involved, and this is a serious concern as it is not age related as most of us would like to believe. The type of hearing aid circuits necessary to address cognition are far more expensive that the OTC’s.
I would like to investigate the motivation of the person who has made such ridiculous and uneducated proposals.
Jay Muhury.
While there are some studies that indicate ear infections can later influence hearing status, it’s generally accepted that noise exposure and the duration of that exposure are the primary culprits in sensorineural hearing loss. Having said that, I would agree there are plenty of good reasons a person complaining of hearing loss should first see a physician or ENT before getting a hearing aid. Although there are manufacturers developing hearing aids that have features which SHOULD lead to a reduction of cognitive load, more comfortable listening, etc, I think it’s also reasonable to state that the KEY factor in forestalling cognitive decline would be audition and speech intelligibility–keeping the brain active with speech information (again, we need more research here). So, it’s properly applied amplification that is the critical component. Finally, whether you agree with them or not, the Committee panel was made up of highly intelligent and knowledgeable medical, research, and hearing professionals; personally, I have no doubt that their motives and intentions were anything other than reporting what they think is best for the consumer.