Hearing connects us to others via communication and gives us an awareness of our surrounding environment, even warning us of potential dangers, as signaled by a siren or alarm. However, the sense of hearing is often taken for granted and hearing loss (HL) viewed as an unfortunate but benign side effect of aging. Despite this common perception, HL is far from benign. Research has revealed independent associations between HL and depression, isolation, decreased functional capacity, changes in social relationships, and altered cognitive capacity (Lin et al., 2013; Mener, Betz, Genther, Chen, & Lin, 2013; Mick, Kawachi, & Lin, 2014; Strawbridge, Wallhagen, Shema, & Kaplan, 2000). Importantly, HL also has a negative impact on patient–provider communication and is associated with misunderstandings in the clinical setting (Blustein, Weinstein, & Chodosh, 2018; Stevens, Dubno, Wallhagen, & Tucci, 2018).
HL is an underappreciated health problem, affecting 38 million Americans. Further, its prevalence increases significantly with age such that HL affects approximately 25% of individuals 65 and older, 50% of individuals 75 and older, and upwards of 80% of those older than 80 (Institute of Medicine and National Research Council, 2014; Lin, Niparko, & Ferrucci, 2011; National Academies of Sciences, Engineering, and Medicine [NASEM], 2016). Notably, based on current aging and population trends, it is estimated that by 2060 more than 73 million adults older than 20 will have HL (Goman, Reed, & Lin, 2017). Given the high prevalence of HL and associated negative health outcomes, HL should be considered a significant public health concern (NASEM, 2016).
Despite the negative effects that HL has on multiple domains, less than 20% to 25% of individuals who might benefit from amplification devices and/or hearing aids own them (Chien & Lin, 2012). There are a number of reasons for this, including perceived stigma from use of hearing aids, lack of screening in primary care, and the fact that HL comes on so slowly that individuals may be unaware of the degree of their loss and what they are missing (Wallhagen, 2009; Wallhagen & Pettengill, 2008). Other key contributing factors are poor affordability and accessibility under the current delivery care model coupled with lack of insurance coverage for hearing care, including hearing aids (NASEM, 2016).
Hearing aids are often referred to as the third most expensive purchase for an older adult, after a home and car. This ranking is due to their high cost, averaging $4,700 per set (NASEM, 2016). Moreover, hearing aids are generally an out-of-pocket purchase because there is minimal private insurance coverage, no Medicare coverage, and varied Medicaid coverage across states (Arnold, Hyer, & Chisolm, 2017; NASEM, 2016). In addition, under longstanding current law, only a licensed person, usually an audiologist or hearing aid dispenser, may dispense hearing aids. However, Medicare recipients must first obtain a referral from a physician for a hearing test and a medical waiver for hearing aids.
This cumbersome system and policies that feature the lack of coverage of hearing aids and hearing care are beginning to change. One of the most notable changes is the recent passage of a bill that charges the U.S. Food and Drug Administration (FDA) with creating a new category of over-the-counter (OTC) hearing aids (Cassel, Penhoet, & Saunders, 2016; Warren & Grassley, 2017; Willink, Schoen, & Davis, 2017). The purposes of the current article are to: (a) briefly review how history and policies, especially Medicare and Medicaid, but also those defining the practice of audiology and dispensing of hearing aids, affect insurance coverage for hearing care; (b) review how a combination of forces brought the need for accessible and affordable hearing care to national attention and resulted in the OTC Act; and (c) discuss the implications of the OTC Act for nurses and nursing practice.
Policies Determining Hearing Care Coverage
The historical evolution of hearing care places its current state in context. Hearing care is a relatively young field. Analog hearing aid technology did not emerge until the 1930s, and the current standard of digital technology did not arrive in earnest until the 21st century. Large numbers of Veterans from World War II returned with noise-induced HL, creating demand for a medical center–based hearing care system, from which audiology was born. At the time, in the private health care sector, few state laws existed regulating hearing care. The field's professional society, the American Speech Language Hearing Association, deemed it unethical to prescribe and dispense hearing aids, introducing regulations to separate HL diagnostics and sale of hearing aids (Mueller, Bentler, & Ricketts, 2013). These regulations led to the creation of a model in which health system–based audiologists diagnosed HL and private dispensers sold the hearing aids; thus, much of the early hearing research was in diagnostics and not hearing aid customization or aural rehabilitation (i.e., counseling and training related to communication and hearing aid use). This separation likely contributed to the perception that hearing care consisted of only a hearing aid rather than including the range of services comprising aural rehabilitation. This perception is reinforced today by a common bundled model of care in which services are included in the cost of the hearing aid purchase. In 1978, a Supreme Court decision that a professional society's code of ethics could not prohibit competition essentially put an end to this separation. Over time, hearing care has moved from a solely diagnostic field to an incorporated diagnostics and aural rehabilitation field (Lowder, Paarlberg, & Harding, n.d.; NASEM, 2016).
Another important policy affecting hearing care is the signing of Medicare and Medicaid into law by President Johnson as Title XVIII and Title XIX of the Social Security Act in 1965. This enactment was the culmination of a long process that involved much debate about coverage and compromises, partly due to the opposition of organized medicine at the time. As designed, Medicare coverage focused on hospital-related expenses (Medicare Part A) with additional coverage (Medicare Part B) for some out-of-hospital expenses, such as physician visits, not covered by Medicare Part A (Anderson, 2018; Social Security Administration, 2015).
Given the politics at the time and the intended focus of Medicare, the final legislation included a specific statutory exclusionary clause related to hearing health care. Section 1862(a)(1)(A) outlines that no payment may be made under Part A or B for hearing aids or the examination for hearing aids. However, a clause exists for Part B coverage of a diagnostic hearing test administered by an audiologist. Notably, this section also prohibits payments for routine eye and dental care (Willink et al., 2017). Coverage for services that fall under this statutory exclusionary clause for diagnostic testing can be covered only if they are considered “reasonable and necessary for diagnosis or treatment” according to Medicare regulations (Sec. 1861 of the Social Security Act). This means that an individual can obtain a hearing test if he/she is referred by a physician for diagnostic purposes. Unfortunately, for those diagnosed with HL, Medicare will not cover the cost of hearing aids or additional services such as fitting or aural rehabilitation. Key to this policy is that Medicare does not view hearing aids as a medical necessity (McNeal, 2016). Most insurance policies follow Medicare's lead and also exclude coverage of hearing aids and hearing services.
Unlike Medicare, Medicaid does not exclude coverage for hearing aids or hearing services, but they are not federally mandated defined benefits. Rather, coverage is state-specific (Arnold et al., 2017). Most states focus on hearing care for Medicaid-eligible children rather than adults. Only 28 states offer some coverage of hearing aids for adults older than 21 under Medicaid and policies differ greatly in eligibility criteria. Moreover, many state Medicaid policies allow for only one hearing aid rather than two. Importantly, all states that cover hearing aids focus on the device rather than the complementary services, such as aural rehabilitation, to maximize benefit.
As noted above, the multi-step process of diagnosis and prescription may be a further barrier to hearing aid uptake. Under state laws, hearing aids must be dispensed by a licensed individual. Under current FDA Federal Regulation Sec. 801.421:
a hearing aid dispenser shall not sell a hearing aid unless the prospective user has presented to the hearing aid dispenser a written statement signed by a licensed physician that states that the patient's HL has been medically evaluated and the patient may be considered a candidate for a hearing aid. The medical evaluation must have taken place within the preceding 6 months.
This regulation ensures no medical pathology requiring treatment is present. However, this regulation combined with the Medicare requirement for a physician referral limits direct access to hearing care and contributes to a system where multiple visits with multiple providers are required to obtain hearing aids. Notably, in December 2016, the FDA announced it would no longer enforce this policy; however, the requirement remains in place in regulatory documents, which has created some confusion among practicing audiologists (Warren & Grassley, 2017).
The combination of the history of hearing care and related policies created a somewhat complicated and cumbersome care delivery model that requires patients to navigate multiple providers and visits. Further, because the focus of current care is on the hearing aid itself, usual care does not include those services that maximize hearing capacity. Finally, the individual is burdened with the associated costs. These circumstances compromise the health and well-being of older adults with HL.
Coalition Building to Change Policy
Given the prevalence and impact of HL, one might believe that policy change to remove barriers to accessible and affordable hearing care should be straightforward. However, unsuccessful attempts to change Medicare coverage date back to the late 1970s when Senator Claude Pepper introduced several bills designed to cover the cost of hearing aids (Joyner, 2018). Further proposed legislative attempts over the years to either cover hearing aids or improve access never emerged from committee. At the time of the current article, the Audiology Patient Choice Act (S2573), which aims to improve direct access to care, would give audiologists limited-license physician status within Medicare. This bill was assigned to the Senate Committee on Finance in March 2018. As this legislation suggests, forces for change began to coalesce in recent years.
For years, personal sound amplification products (PSAPs) that amplify sound have existed as unregulated devices available for direct consumer purchase. These devices range in cost from $19.99 to $400 but are not FDA approved and cannot be marketed as hearing aids or devices for HL (Reed, Betz, Lin, & Mamo, 2017). Although not promoted for this purpose, survey data suggest individuals with HL adopt PSAPs to treat their HL in lieu of traditional hearing care (Kochkin, 2010). Traditionally, these devices were of poor quality; however, in recent years, select PSAPs have proven more technologically capable and compare well to hearing aids on basic listening tasks (Reed, Betz, Kendig, Korczak, & Lin, 2017). The emergence of these more technologically advanced devices began to challenge hearing aid manufacturers and pressure the hearing care system to consider new models of care.
On another front, data supporting the association of HL with numerous negative health outcomes have grown significantly. This cumulative body of research was part of the catalyst for multiple scientific bodies to turn their attention to HL. In 2009, the National Institute on Deafness and Other Communication Disorders/National Institutes of Health sponsored a working group focusing on accessible and affordable hearing health care (Donahue, Dubno, & Beck, 2010). An outgrowth of this effort was the call for research to develop, improve, and lower the cost of hearing aids. This effort ultimately led to the establishment of the Committee on Accessible and Affordable Hearing Healthcare in 2015 under the auspices of the NASEM, formerly the Institute of Medicine. In June 2016, the NASEM committee published its comprehensive consensus study, which made 10 major recommendations, including the call to further study the impact of HL across multiple conditions, educate practitioners and others, integrate hearing screening into primary care, and meet the needs of underserved populations. Importantly, the report acknowledged the advanced PSAPs available and recommended consideration of an FDA–approved class of OTC wearable hearing devices for mild to moderate HL (NASEM, 2016).
Almost serendipitously at the 2015 White House Conference on Aging, technology in the context of age-related mild to moderate HL was investigated as part of a larger focus on technology for older adults. In October 2015, The President's Council of Advisors on Science and Technology (PCAST; 2015) published a report in a letter to the President that included multiple recommendations to improve access to hearing care, including the creation of a distinct category of “basic” hearing aids that could be purchased OTC.
Media interest heightened with the combination of an increasingly technologically advanced PSAP market, HL research focused on negative health outcomes, and attention from major scientific and policy parties. This combination increased public awareness of the issues surrounding hearing care. In addition, as the population aged, more older adults with HL became aware of their lack of options and the fact that Medicare did not support HL treatment. In addition, consumer groups, such as the Hearing Loss Association of America and AARP®, were emboldened and stepped up their efforts to advocate for hearing health care services.
These NASEM and PCAST reports received a great deal of attention from industry, the public, and Congress. Subsequently, in March 2017, Senator Warren, along with Senator Grassley, introduced Senate Bill 670, titled “Over-the-Counter Hearing Aid Act of 2017.” The bill amended Section 520 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j) to incorporate a category of OTC hearing aids for individuals with mild to moderate HL and mandated that facilitating regulations be developed in no more than 3 years (Warren & Grassley, 2017). The bill passed and was subsequently incorporated into H.R. 2430, the FDA Reauthorization Act of 2017, which was signed into law by the President on August 18, 2017. The FDA has until 2020 to prepare the standards and regulatory process for OTC hearing aids.
Although this new legislation does not address insurance coverage, the purpose of these OTC hearing aids is to alter and complement the current model of access. OTC hearing aids will provide enhanced accessibility while also easing entrance into the hearing aid market for new companies. Market forces should contribute to lower costs and increased awareness as manufacturers are challenged to compete and market their products. Further, this legislation may also help alter the practice of audiologists by allowing them to focus more on aural rehabilitation, assisting individuals with developing enhanced communication strategies and more effectively handling their HL overall, as the sale of hearing aids for many individuals will be separated from the provision of services.
Implications of the OTC Legislation for Nurses and Nursing Practice
Changing policy involves far more than developing a policy statement or bill, even if the policy addresses an obvious need. Instead, policy changes with the coalescence of multiple forces. Importantly, the NASEM report, with its extensive analysis, brought the issue of HL to the fore as a public health issue. HL is a vital issue for nurses who care for older adults, as many older adults have some degree of HL. As advocates, nurses can play a critical role in promoting appropriate care and access for individuals with HL who need traditional hearing aids. Although OTC hearing aids may enhance access, health care professionals should continue to advocate for insurance coverage for hearing aids to completely remove cost as a barrier and improve services to maximize the benefit of hearing aids. Despite the fact that, dating back over 40 years, proposals for Medicare to cover hearing aids have failed due to concerns about the cost, advocates propose that hearing care provided by Medicare could be preventive in nature (i.e., reducing social isolation) and reduce long-term costs (Willink et al., 2017). More data are accumulating that support the cost-effectiveness of coverage to health care, but these data have been difficult to obtain and slow to produce. Concurrently, research exploring how hearing aid use impacts health outcomes, such as cognitive decline and other negative health effects, could alter Medicare's stance on the medical necessity of hearing aids.
As frontline providers, nurses will play a key role in shaping the immediate future of hearing care, especially in the framework of OTC hearing aids. The Table provides a checklist for addressing hearing loss in the health care system. Nurses can contribute by screening for HL in all health care settings using simple methods such as asking questions related to difficulty hearing combined with either a standardized finger rub or whisper test (Strawbridge & Wallhagen, 2017). Upon screening, nurses are in a key position to help older adults navigate the new hearing care model. As noted above, OTC hearing aids will target individuals with mild and moderate HL. Further, comfort with technology and health literacy may be required to self-fit a device. Nurses are well-suited to help individuals discern whether this new category of hearing aid is appropriate for their HL and whether they would be comfortable using an OTC device or whether traditional services are a better route.
Addressing Hearing Loss in the Health Care System Checklist
Screening has implications beyond identification and advising on next steps. HL has direct implications for patient–provider communication in the clinical setting. Poor communication and misunderstandings related to hearing impairment are associated with poor treatment adherence and can result in negative health outcomes (Zolnierek & DiMatteo, 2009). The Table outlines technological and communication strategies that nurses can use to help overcome HL in the health care setting. Moreover, nurses should take a lead role in championing the awareness of HL among all providers and staff to improve patient–provider communication.
We are entering a new era for hearing care. The importance of hearing to general as well as cognitive health is finally being acknowledged, and models of care are being challenged in ways that will allow a broader array of individuals with HL to obtain services. These changes bring important opportunities for nurses to understand the importance of hearing alone and also advance new models of care to enhance the quality and safety of care received by older adults and their families.
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Addressing Hearing Loss in the Health Care System Checklist
| Handheld amplification||Simple handheld devices, such as the PocketTalker® or SuperEar®, allow users to use standard headphones and easily amplify sound to their desire with the volume control to improve communication.|
| Amplified and caption telephones||These telephones are specially designed for individuals with hearing loss (HL) and provide increased amplification and captioned conversation.|
| Remove background noise||Reduce background noise by turning down the television or radio and closing the door to noisy areas to improve communication. If the noise cannot be removed, try going somewhere away from the noise for communication.|
| Improve room lighting||This is a balancing act. Proper lighting helps individuals with HL visualize the speaker to aid in lip reading but overwhelming lighting (e.g., a window reflection) can be distracting.|
| Use sound absorbent materials||Carpet, drapes, and even acoustic foam placed on the walls can improve the reverberant (i.e., echo) qualities of a room.|
| Ensure attention||Start conversation and communication when both parties are attentive and ready. Consider body position, ideally seated at the same level for optimal eye contact.|
| Face-to-face communication||Ensuring that the listener can see your face to leverage lip reading skills is important. This also ensures sound is being directed at the listener rather than in another direction.|
| Do not cover mouth area||Many individuals consciously and subconsciously lip read to help follow conversation.|
| Speak slow and low||HL is a clarity issue rather than a volume issue. Slowing down and using a slightly lower tone can help listeners with HL follow the conversation.|
| Do not shout||Shouting does not help and often further distorts information.|
| Give context to conversation||Place the conversation in some kind of context to help the listener decipher difficult to hear words.|
| Rephrase rather than repeat||Rephrase remarks to help the listener gain new context about the conversation and use words that are easier to hear. Repetition can create a frustrating negative feedback loop.|