Future States for Hearing Care

Abstract

Evolutionary changes occur across health care, including within the hearing care delivery system. At times, the change is driven by external forces and thus elicits a reactive response. In contrast, developing a vision of a future state, and subsequently the strategies to achieve that vision, is a proactive and a preferred process. Using the reactive versus proactive framework, a future state built around the emergence of genetics as both an assessment tool and a treatment option is presented. In addition, a broad, consumer-centric vision for access to affordable and contemporary hearing care is presented that would result in an expanded and positive future state for hearing care services.

THE PAST IS PROLOGUE

The evolution of hearing care is often considered in the context of contemporary assessment paradigms or improved outcomes with hearing aids or implantable devices. Indeed, there have been significant advancements in both areas. Otoacoustic emissions have become more integrated into clinical protocols and frequency-specific electrophysiologic measures have become the norm for hearing assessment in the pediatric population. Digital technology has improved the accuracy, speed, and potential of tests used to assess the auditory system as evidenced by immittance testing and wide-band reflectance. Knowledge regarding the function of the auditory system has expanded, leading to greater understanding of the origins and consequences of hearing loss. And the advent of genomics has expanded the assessment of hearing to include possible genetic origins of hearing loss.

This evolution of the technology and techniques for hearing assessment has led to improvement in the diagnosis of auditory system status. In turn, this has led to improved clinical decision making with respect to treatment opportunities. Despite persistent concerns with the acceptance and utilization of hearing aids, the devices themselves have progressed from simple sound amplifiers to noise filtering systems to smart phone connected devices, and to ear-level motion sensors that can detect falls. Implantable devices have become a primary treatment option for a certain subset of the population with hearing loss, and the sound-processing algorithms used in the devices continue to improve, leading to better and better outcomes. Brainstem implants are being investigated for their potential as a treatment option for persons with neural agenesis or loss.

The evolution of hearing care also can be considered within an economic, political, or educational framework. Consider the recognition of hearing care services by third-party payers. This recognition has allowed newborn infant screening to occur on a widespread basis, as the follow-up audiological services are accepted as services that are appropriate and payable. Medicare payments for audiologic services have evolved from the days of not paying for audiologic assessments if the only outcome was a recommendation for a hearing aid to payment for those same services even if a recommendation for a hearing aid is the only outcome. Politically, licensure laws have been put into place that negated the requirement for certification, provided a means to protect the consumer from fraudulent practices, and assured continued education for practitioners. Lobbying at the national level led to recognition of audiologists by the Federal Employees Health Benefit Plan. The Food and Drug Administration (FDA) routinely contacts professional organizations in audiology for input on hearing care–related issues, a recognition of the evolution of contributions of the profession to health care. In the educational realm, advances in teaching, learning, curricula, and academic degree structure have all been part of the evolution of hearing care.

REACTIVE VERSUS PROACTIVE

In the world of neuroscience, the concept of bottom-up processing suggests using the real-time sensory input to construct perceptions, whereas top-down processing suggests using context and general knowledge to understand sensory perceptions. There is a somewhat analogous perspective in the world of evolutionary change in hearing care, particularly when it comes to professions. In the case of bottom-up processing, the analogy is to be reactive to externally driven evolutionary events and determine if and how the event fits in with some future vision. Conversely, the top-down processing analogy is to develop a vision and then to be proactive in developing strategies to achieve that vision.

Within the hearing care realm, the “over-the-counter” (OTC) hearing aid legislation that was included in the FDA Reauthorization Act, and signed into law by President Donald Trump in 2017, is an example of a reactive response to change. The law directed the FDA to create regulations for a hearing aid that could be sold to the consumer without the need for professional assistance. The so-called OTC hearing aid legislation, when first introduced, set off a flurry of reactive activity on the part of state and national professional organizations, consumers and consumer organizations, device manufacturers, third-party payers, and individual hearing care providers. The discussions at that time revealed a myriad of perspectives regarding the impact of OTC devices. There were those who felt that increased access and lower price points for OTC devices would be a benefit for consumers and a death knell for hearing care practices. Others thought that OTC devices would have little impact on existing practices and that the provision of hearing care would remain status quo. Still others saw an opportunity to expand practice offerings by included OTC devices as part of a broader treatment program. In all these cases, the introduction of the legislation triggered reactive responses (bottom-up) from various stakeholders.

Now consider the Affordable Care Act (ACA), signed into law in 2010 by President Barack Obama. The proactive goals of the ACA were to expand access to health care for more persons and develop innovative medical delivery mechanisms to lower costs. ¹ Often referred to as “Obamacare,” this law significantly changed the landscape of health care by increasing the number of persons eligible for health insurance through Medicaid, developing insurance marketplace exchanges for persons with higher incomes but no employer-based insurance coverage; addressed issues such as the denial of coverage for preexisting conditions; and rearranged the basis for payments from federal health care payers by shifting from fee-for-service payments to value-based payments. This legislation began with a proactive vision, that is, health security for all, and then progressed to develop the strategies and tactics that led to passage and implementation of the ACA.

The reactive/bottom-up or proactive/top-down analogies are not mutually exclusive in the world of government affairs. In fact, both operate simultaneously. In the case of the ACA, each of the various stakeholders (e.g., hospitals, providers, insurance companies, and consumers) engaged in intensive reactive activity, each trying to position themselves to minimize any negative impacts in the law and maximize any benefits that might be realized. For example, third-party payers were concerned over increased expenses due to the elimination of the preexisting condition clause. Hospitals had to understand the impact on service delivery that might occur with elimination of the monies that provide support for care for the uninsured, and providers had to consider the financial threat associated with the requirement for implementing the use of electronic health records within practices. With the passage of the ACA, federal agencies such as the Department of Health and Human Services (DHHS) and the Centers for Medicare and Medicaid Services (CMS) began developing the rules and regulations for implementation of the law. Again, by necessity, stakeholders had to be engaged with the process, if only to protect their interests, as the rules and regulations were promulgated. So, while the ACA itself was a proactive event, it triggered reactive events for stakeholders.

Legislation is the act of a congressional body. Regulations stem from government agencies charged with implementing legislation. In the case of access to OTC hearing aids, the U.S. Congress passed the legislation that directed the FDA to develop regulations that govern the practice of OTC devices. The multitude of government and nongovernment agencies, plus the diversity of stakeholders, means changes to the healthcare system, including audiologic care, occur frequently and often. The OTC hearing aid and Affordable Care Act legislation, state licensure laws, FDA oversight of medical devices such as cochlear implants, and third party and Medicare payment methodologies for audiologic services, to name a few, are examples of the myriad of the ever-evolving laws, rules, and regulations that impact hearing care. Some of these changes are initiated by primary stakeholders such as professional communities. Others occur at the request of industry who desire approval of new audiologic technologies. Still others occur out of the desire to protect the consumer from unethical practices.

Legislative change can occur at the local, state, or federal level, and regulatory change can occur within hundreds of government agencies across the United States. For example, CMS published a proposed rule in 2021 that updated the clinical labor pricing for audiologists by 77%. (This index is used to establish the RVU value for CPT codes.) Another example is the FDA relaxing enforcement of the rule requiring a signed medical waiver prior to the purchase of a hearing aid. Beyond the legislative and regulatory arenas, rule changes also can occur within industries such as third-party payers, or even at the level of an individual employer. For example, a follow-up audiological evaluation for determining the benefit of a hearing aid may not be paid by an insurance company, but the identical assessment as a follow-up to cochlear implantation may be covered by insurance.

When considering any legislative, regulatory, or rule changes, it is important to be mindful of the diversity of stakeholders that may be involved and/or driving change. The stakeholders in the hearing care realm include audiologists, otolaryngologists, hearing instrument dispensers, consumers (patients), professional societies, gene therapy companies and medical device manufacturers, state and federal health agencies, and third-party payers. Depending on the issue, stakeholders also may include other medical or allied health professions, hospitals or health networks, academic programs or universities, or agencies that fund research.

Monitoring the healthcare landscape and the actions of various stakeholders is a necessary function of any profession to be able to react to developments from external sources, particularly when those actions directly impact providers or patients. However, being proactive , establishing an internal vision for a future state, provides the opportunity to create desired outcomes.

POSSIBLE FUTURE STATES

Understanding the past, and the evolutionary changes that have occurred over that time, provides a starting point for considering possible future evolutionary developments. Predicting future evolutionary change, particularly beyond the short term, is speculative at best. However, as Nobel Prize winner Dennis Gabor noted in 1963: “The future cannot be predicted, but futures can be invented.” ² Rather than attempting to predict a future state, particularly those driven by external forces, it is better to consider areas in which the audiology profession could drive change in hearing care. Stated as a question, what future state can be invented for the audiology profession? Certainly, there could be many perspectives on what the future might hold, or, more correctly, what future could be invented. Table 1 provides examples of possible future states for hearing care that could serve as a basis for proactive actions.

Table 1. Examples of Domains, Elements, and Future States for Hearing Care.

Domain	Element	Future state
Clinical	Genomics as a diagnostic tool	Audiologists directly refer for genetic testing, when necessary and appropriate, as part of the diagnostic assessment
	Radiologic imaging as a diagnostic tool	Audiologists directly refer for imaging studies, when appropriate and necessary, as part of the diagnostic assessment
	Functional measurement of the auditory system	Audiologists utilize evolving electrophysiologic and functional imaging measures to assess auditory and vestibular system function
	Automated assessment of the auditory system status	Assessment of auditory function, either during diagnostic or treatment phases, can be accomplished using technologies that improve efficiency, accuracy, and timeliness
	Pharmacologic and gene therapy as treatments for hearing loss	Audiologists determine candidacy for emerging treatments and, when necessary and appropriate, administer those treatments
	Frequency of audiologic assessments	The frequency by which individuals, with and without hearing loss, should have audiologic assessments is established across the lifespan
	Artificial intelligence to support treatment technologies	Devices can respond to individual needs and changing environmental soundscapes to restore auditory performance
Professional	Licensure laws; state compact	State licensing laws should be consistent from state to state to allow consistent understanding of scope of practice. State compacts should be enacted to allow efficient delivery of services across state lines
	Increased recognition by Medicare (CMS) and other third-party payers	Improved payment for audiologic services across the scope of practice and in advance of expanded services
	Standardized educational outcomes	Standardization of academic programming to ensure consistent knowledge, skills, and competencies of graduates
	Increase the number of audiologists	The number of audiologists in the United States is doubled over the next 10 years
Administrative	Telehealth	The use of telehealth expands, consistent with state licensing laws, such that 30% of all audiology encounters is via telehealth. Assessment and treatment paradigms are developed that utilize telehealth
	Consumerism in hearing care	The voice of the consumer is embedded in the creation of hearing care paradigms for the future
	Social determinants of health and health equity	The audiology profession utilizes social determinants of health to improve access and efficiency of care and increases access to services in geographic locations that are currently underrepresented
	Value-based care	A model process for providing value-based care, including expected outcomes, is created and utilized by the audiology community
	Data and outcomes	National benchmark data are developed that provides demonstrative positive outcomes for hearing care services, including the outcomes with hearing aids

Notes: Some of the factors are related to the capabilities of the individual, while others are related to technological or methodological evolutionary advances, or to evolution in the profession.

The table is intended to provide examples of future states, not a comprehensive or exhaustive list of possibilities.

By way of example, the Element titled “Frequency of audiologic assessments” suggests a future state where there is a common and evidence-based derived standard for the frequency by which the public should have audiologic assessments. Creating this future state would provide greater standardization of care, is useful for scheduling follow-up care, and can be used as the cornerstone for educating the public on the importance and timing of hearing assessments. This future state would, by necessity, require engagement across stakeholders, government and nongovernmental organizations, professional associations, and legislative and/or regulatory bodies.

A second example is the Element titled “Increase the number of audiologists” which suggests a future that expands service providers to meet the needs of a growing population. In 2013, Windmill and Freeman predicted a shortage of audiologists, particularly given the expanding population of those older than 60 years. ³ The future state associated with this element is a doubling of the number of audiologists. This future state would require that academic programs expand in size (including a reconsideration of the experiential aspect of education), that efforts be made to publicize audiology as a career option, that employers and practices expand purposely, and that salaries and compensation increase to levels that are attractive to prospective students.

This is by no means a complete list of possibilities, but rather is presented to provide perspective as to the type of proactive actions that could occur across clinical, professional, and administrative domains. Many of these factors will continue to evolve even without a proactive approach, and subsequently impact hearing care. The question becomes which factors require an intentional, proactive approach, and which can be left to a reactive approach? While each of these factors deserves consideration for creating a future state, the remainder of this article will focus on two topics where a proactive approach is advocated. The first is the matter of genetics in the delivery of hearing services and the role for audiology in this delivery paradigm. The second is an aspirational, consumer/patient centric goal that overarches many of the factors in Table 1 —the construct of improving access to hearing care for all persons.

GENETICS AND HEARING CARE

A recent conference organized around developments in the area of inner ear disorders therapeutics provides evidence that genetic and pharmacologic treatments for hearing loss will soon be emerging: Inner Ear Disorders Therapeutics Summit. ⁴ The mapping of the human genome, in combination with emerging genetic treatments for inner ear disorders, suggests an alternative clinical pathway for patients with hearing loss in the future. The traditional path of identification of sensorineural hearing loss, leading most commonly to treatment with amplification systems, would have to be reconsidered. If underlying genetic origins of the loss become amenable to treatment, particularly if the anatomical and physiologic substrates of hearing could be even partially restored, then consideration of genetic evaluations as part of the diagnostic workup would have to be included. Moreover, alternative treatment pathways that consider gene therapies as an option also would have to be identified.

This begs the question as to the role of audiology within this future state. Table 1 identifies two factors related to a future state for audiology where genetics play an important role. First is the concept that audiologists can refer for genetic testing, when necessary or appropriate, as part of the diagnostic assessment and that the results of this testing are incorporated into the clinical decision process. The second concept is that audiologists determine candidacy for emerging genetic and pharmacologic treatments and, when necessary and appropriate, administer those treatments. Combined, these factors suggest a future state for audiology practice that includes the determination as to which patients might need genetic testing, be able to refer directly for the tests without the need to go through a physician, integrate the results of the genetic panel into the development of a treatment plan, and then, in certain circumstances, administer that treatment. Currently, genetic testing is not a substantial part of the diagnostic process for persons identified with hearing loss, except perhaps within the pediatric population. Even with this population, patients must be referred to their primary care physician and/or otolaryngologist for referral for genetic testing. Adopting the position that some treatments might be provided by audiologists will provide the opportunity to identify clinical pathways that are cost-effective and appropriate.

A proactive approach to these factors would lead to the development of strategies and tactics to achieve the described future state for audiology in the area of genetics. This is quite a complex undertaking that would include at least the following elements:

• Developing an understanding of the benefits and challenges to patients and practitioners regarding the impact of embracing the dual goals of referral and treatment.

• Supporting research to identify which populations should be referred for genetic testing and how to determine specific genetic panels to be assessed. (This element will continue to evolve over time due to advancements in genetic testing.)

• Identifying and promoting the clinical and financial benefits associated with direct referral from audiologists to geneticists.

• Identifying the appropriate patient care pathways associated with various genetic conditions.

• Determining typical and best outcomes for treatments and identifying sequencing of treatments.

• Determining the treatment options associated with each genotype and phenotype and determining which treatments may be available to audiologic practice.

• Understanding the cost–benefit relationships between current and emerging treatments, including the cost on quality of life, vocational opportunities, educational achievement, and socioeconomic impact. Currently, existing gene therapies for retinal disease ($425,000) or spinal muscular atrophy(>$2 M) can be expensive. ⁵

• Creating partnerships with relevant stakeholders to broaden support for the initiatives, including those companies developing genetic (and pharmaceutical) treatments, consumer organizations, and third-party payers.

• Establishing the educational parameters for teaching genomics, including a comprehensive understanding of the genetic origins of hearing loss, genetic testing, integration of test results, and treatment processes for specific genotypes and phenotypes in the curricula of academic programs.

• Identifying the educational requirements for existing practitioners to gain competence in these areas and determining a means to measure that competence.

• Reviewing potential legal and regulatory obstacles to achieving the goals, and then developing strategies to mitigate the barriers.

• Lobbying the multitude of third-party payers to permit the direct referral of patients and for payment of those services.

• Changing Medicare and Medicaid regulations to permit referral and/or treatment of patients with possible genetic components to their hearing loss, and for payment for those services.

As can be seen, the development of a proactive strategy to achieve the goals associated with audiology's role in genetics would involve professional organizations, researchers, relevant stakeholders, academic programs, federal and state agencies, and individual practitioners. Anticipation of the timing and breadth of changes would have to be considered and specific actions proposed that could be initiated in the correct sequence and in a timely manner. As gene therapies (and pharmacologic treatments) for hearing loss are imminent, a proactive approach provides the opportunity for leadership in clinical care.

A BROADER PERSPECTIVE FOR THE FUTURE

The World Health Organization defines health policy as: “… [health] goals at the international, national, or local level and specifies the decisions, plans and actions to be undertaken to achieve these goals. An explicit health policy can achieve several things: it clarifies the values on which a policy is based; it defines a vision for the future, which in turn helps to establish objectives and the priorities among them; and it facilitates setting targets and milestones for the short and medium term.” ⁶

This definition specifies that health policy is built around the idea of health goals; the potential reach of the policy, that is, at the international, national, or local levels; as well as the plans and actions to achieve the specified goals. The definition then goes on to state that the policy includes a vision of the future, and the setting of targets for the short and medium term. Broadly then, health policy is a proactive vision of some future state, establishes strategies and tactics to achieve the vision, and provides guidance on the roles and responsibilities of the stakeholders involved. Moreover, it should establish benchmarks and metrics by which to measure progress at achieving the desired outcomes.

Health policy is aspirational and, therefore, suggests a longer-term perspective for a desired future state. The list of opportunities to expand hearing care services in Table 1 is primarily focused on specific (individual) elements within the hearing care realm. There is no unifying theme. Consider, however, that the mission of audiologists is to care for persons with hearing loss, and therefore it is beneficial to consider a broader health policy in terms of the consumer/patient. In this regard, a desired future state (health policy) might be: “All persons, regardless of age, location, or socioeconomic status, can access contemporary and affordable hearing and balance care.” A consumer-centric perspective provides greater opportunity to positively engage stakeholders, particularly the consumer groups that represent persons with hearing loss.

This aspirational goal has the following advantages:

• It promotes access for all persons, regardless of geographic location or socioeconomic status.

• It is consumer centric, yet can engage all stakeholders, including patients, professional, organizations, government and nongovernment agencies, and individual practitioners.

• It allows the development of simultaneous strategies across multiple fronts.

• It accounts for evolutionary changes that might occur within the hearing care realm.

• It encourages greater participation by consumers in obtaining hearing care services.

• The term “affordability” pointedly addresses concerns from the public about cost.

• The term “contemporary” suggests the need to incorporate emerging treatments such as the aforementioned genetic or pharmaceutical options.

• It can be a unifying theme across many elements (see Table 1 ).

• Decisions related to externally driven change can be made based on the extent to which it helps meet the vision.

• Similarly, decisions regarding allocation of resources can be made based on the likelihood of a return on the investment to fulfilling the vision.

Increasing access has the net effect of increasing utilization of audiologic services. This can lead to increased volumes of patients, greater public visibility, and expanding practice opportunities. This is not to say that there would not be obstacles to achieving this health policy. Certainly, metrics would have to be established to measure progress and determine the endpoint. Determining the next steps would be a challenge, as would managing multiple strategies at once. Determining where to put limited resources also would be a challenge.

Consider the reactive response to the OTC legislation in the framework of a future state that includes the concepts of access, affordability and contemporary care. In this regard, thoughtful deliberation as to how this legislation fits within that framework would occur, with subsequent determination as to how to provide input to the legislation and regulation. Certainly, the OTC legislation proposed to address both access and affordability. Thus, there would be reason to support the legislation. Conversely, there may need to be input, including lobbying, to assure that the OTC devices were of sufficient quality as to meet the definition of contemporary care. Irrespective of the outcome or one's position on the OTC legislation, having a proactive vision of a future state provides a framework on how to react to an external force of change.

Developing strategies for attaining a goal of creating affordable and contemporary hearing care is based on identifying those factors that would be critical to attaining the goal. Fig. 1 lists examples of key drivers that could be created to reach the goal.

Figure 1.

Examples of key drivers and strategies and tactics for attaining the goal of contemporary and affordable hearing care for all.

Health Policy and Future States

Health policy is aspirational in nature and a vision of a preferred future state that helps establish priorities for action and a framework for reaction. Among the strategies for achieving health policy can be affecting change to legislation, regulation, or rules in both government and nongovernment agencies. In addition, health policy can require change in the clinical, educational, or economic arena. Health policy, then, is the top-down/proactive perspective, and helps create evolution but also allows for appropriate bottom-up/reactive decision making to external change.

The potential for gene therapies as an evolutionary development in hearing care and developing a vision where everyone has access to affordable and contemporary care are both possible future states, and both possible areas to establish health policies. One can debate whether either of these are priorities, but they are provided as examples of developing a proactive vision. Also, neither is static. Both can, and likely would, be modified over time as external and internal forces come to bear on the vision. But a vision for a future state provides the classic example of beginning with the end in mind, and subsequently creating the opportunities to achieve the end goal. A coherent and common vision for the future provides clarity for the role of each stakeholder, and the shared responsibilities for achieving the future state.