Working Group on Accessible and Affordable Hearing Health Care for Adults

June 20-21, 2024
Bethesda, Maryland

• Agenda
• Participant List

Workshop Summary

On this page:

• Executive Summary
• Detailed Summary
  • Background
  • Working Group Composition and Focus
  • Agenda and Working Group Format
  • Research Recommendations

Executive Summary

The National Institute on Deafness and Other Communication Disorders (NIDCD) and the National Institute on Aging (NIA), both part of the National Institutes of Health, in partnership with the U.S. Food and Drug Administration (FDA), hosted a two-day meeting focused on hearing health care access and affordability. This area has been a priority for NIDCD since 2009, starting with the NIDCD Working Group on Accessible and Affordable Hearing Health Care for Adults with Mild to Moderate Hearing Loss. Over the last fifteen years, these efforts have supported many advances in hearing care, including the FDA’s final rule allowing over-the-counter (OTC) hearing aids, which went into effect on October 17, 2022.

The goal of the 2024 working group meeting was to hear from subject matter experts and partners about hearing health care needs that remain, and about new work that should be conducted both in the context of OTC hearing aid availability and, more broadly, in the changing health care landscape. Experts who participated in the workshop contributed their ideas through presentations and panel discussions. These individuals have not had—nor will they have—a role in formulating, recommending, or determining any funding initiatives.

Concurrent with the meeting, NIDCD published a Request for Information (RFI) seeking public comment from all interested parties (individuals or groups) on NIDCD’s future research directions toward improving the accessibility and affordability of adult hearing health care.

Key themes (11) identified from work leading up to and including the workshop, and from responses to the NIDCD RFI, are:  

• Consequences of unaddressed hearing loss
• Stigma
• Screening and assessment
• Care seeking
• Care delivery systems
• Hearing care outcomes
• OTC hearing aids
• Technology
• Economic and policy implications for hearing health care
• Workforce
• Overarching topics

Detailed Summary

Background

NIDCD is the lead federal agency promoting the nation’s hearing care. The institute supports basic and translational research on the normal and disordered processes of hearing and communication disorders, as well as science focused on the care and rehabilitation of people of all ages with hearing loss. This includes work to systematically explore and prioritize hearing health care access and affordability.  

For many reasons, the current hearing health care system in the U.S. is not meeting the needs of many adults with hearing loss. In 2009, NIDCD sponsored a working group on Accessible and Affordable Hearing Health Care for Adults with Mild to Moderate Hearing Loss, the purpose of which was to develop a research agenda to increase access to, and affordability of, hearing care, including accessible and low cost hearing aids. The workshop generated a series of recommendations and prioritized them based on importance and feasibility. This process launched a concerted effort by the institute to encourage, support, and prioritize research that would address these needs. These efforts have driven important changes in the hearing health landscape. 

The President’s Council of Advisors on Science and Technology (PCAST) took up the issue of adult hearing health care in 2015, recognizing that untreated hearing loss, particularly in older Americans, “is a substantial national problem.” PCAST generated a series of recommendations (PDF | 168 KB) that the federal government could quickly take to open the hearing aid market, lower hearing health care costs, and promote innovation. At nearly the same time, NIDCD, along with several federal and advocacy partners, supported a 2016 National Academies of Sciences, Engineering, and Medicine (NASEM) consensus study on adult hearing health care, with an emphasis on access and affordability. The resulting report recommended a series of key institutional, technological, and regulatory changes that prioritized the needs of individuals with hearing loss.

Notably, the call for a lower cost, direct-to-consumer hearing aid service delivery model was unanimous among the recommendations generated from the 2009 NIDCD working group, the 2015 PCAST report, and the 2016 NASEM consensus study. NIDCD-funded studies demonstrated that an OTC model of hearing aid distribution could be safe and effective. In 2017, bipartisan legislation was passed directing the FDA to develop a first-of-its-kind category of OTC hearing aids that would be available directly to adults with perceived mild to moderate hearing loss, without the assistance of a professional. In October 2022, the FDA’s OTC hearing aid rule was finalized and put into practice.

While much headway has been made on issues of access and affordability in adult hearing care, many opportunities for progress remain, and many new questions have been generated by changes in policy and care delivery. Continued collaborations and an intentional focus on actionable research priorities remain necessary. Thus, 15 years after the initial NIDCD-convened working group, the institute assembled another working group of subject matter experts and partners to re-evaluate the adult hearing care landscape in the context of OTC hearing aid availability.

In conjunction with the meeting, NIDCD published a Request for Information (NOT-DC-24-029) inviting input from all interested parties on NIDCD’s future research directions toward improving the accessibility and affordability of adult hearing health care. Specifically, the RFI welcomed thoughts from individuals and groups about the needs and opportunities to improve adult hearing health care toward a determined and ideal outcome(s), with an emphasis on access and affordability. The RFI sought comments on a wide range of issues including improvements in technology, innovations in service delivery, and factors that drive timely uptake and access. The RFI was open for comment from June 3 to August 14, 2024.

Working Group Composition and Focus

The working group was co-chaired by Dr. Sumitrajit Dhar, Northwestern University, and Dr. Carrie Nieman, Johns Hopkins University, and co-led by NIDCD staff members Dr. Kelly King and Dr. Jaclyn Schurman. The workshop was co-funded by NIDCD, the FDA, and NIA. Additional planning support was provided by FDA staff, including Drs. Srinivas “Nandu” Nandkumar, Eric Mann, and Julie Cohen.

In total, the working group comprised 29 individuals from U.S. and international institutions, including scientists, clinicians, advocates, technologists, grantors, regulators, and individuals with hearing loss. The working group met in person over a day and a half and was charged with considering hearing loss through a public health lens, including societal consequences and societal responsibilities. Working group members were not selected to represent needs or agendas of organizations or industries to which they belong, and were instructed to leave aside any such agendas. The group was not convened to achieve consensus. Rather, the goal was to hear from subject matter experts and partners about research gaps and priorities, including those that remain as well as new challenges and opportunities in the context of OTC hearing aid availability and, more broadly, the changing landscape of health care. From these discussions, research topics and recommendations emerged.

Representatives from the American Academy of Audiology (AAA), AARP, American Auditory Society (AAS), Academy of Doctors of Audiology (ADA), American Speech-Language-Hearing Association (ASHA), Ear and Hearing, Hearing Loss Association of America (HLAA), Hearing Industries Association (HIA), International Hearing Society (IHS), and the Patient-Centered Outcomes Research Institute (PCORI) attended as invited observers. Invited U.S. government agencies included the Administration for Community Living, Centers for Disease Control and Prevention, Centers for Medicare and Medicaid Services, U.S. Department of Defense, Federal Trade Commission, Health Resources and Services Administration, and the U.S. Department of Veterans Affairs. Additional NIH and FDA staff, as well as members of the public were in attendance.

Although non-working group members were not able to ask questions or comment during the meeting, they were encouraged to provide feedback through the open RFI and to disseminate information about the RFI widely.

Agenda and Working Group Format

In preparation for the working group, the co-chairs and NIDCD co-leads evaluated recommendations made from the 2009 NIDCD Working Group, the 2015 PCAST report, and the 2016 NASEM consensus study to determine which recommendations had been met or sufficiently addressed and which gaps remained. These gaps were highlighted in a reflection guide provided to the working group before the meeting to serve as a prompt for discussing factors that facilitate or impede realization of affordable, accessible hearing care.

The format of the meeting and reflection guide were informed by a framework from a 2013 paper by Levesque, et al., about envisioning what it means to access health care. The meeting (see the full agenda) was divided into the following discussion sections: 

• Section 1: Hearing health care needs, perceptions, and desire for care
• Section 2: Hearing health care seeking, reaching, and utilization
• Section 3: Hearing health care consequences and outcomes
• Section 4: Technology as an enabler of access

Health disparities were addressed in each section as an overarching theme. Working group participants were provided with articles and related documents to review prior to the meeting, and were encouraged to consider research needs and priorities in advance of the meeting.

The meeting convened with opening remarks from Dr. Debara Tucci, Director, NIDCD, and Dr. Jeff Shuren, Director of the Center for Devices and Radiological Health (CDRH) at the FDA. The charge of the working group was delivered by Dr. King, including the goal to develop actionable research priorities with an eye toward public health and with the understanding that consensus was not required.

Drs. Dhar and Nieman, co-chairs, provided an overview of the meeting, including background work accomplished in preparation, an expanded view of meeting goals, and an orientation to the framework that drove the organization and design of the meeting.

The meeting proceeded with three opening keynote addresses: 1) the intersection of health care policy and research, 2) health care economics, and 3) health disparities with an emphasis on the National Institute on Minority Health and Health Disparities research framework.

The remainder of the day was spent addressing the first three of four discussion sections from the modified framework. Each section began with brief presentations from invited working group panelists, with the majority of the time reserved for panel discussion facilitated by the meeting co-chairs.

The second day resumed with a recap of day one, followed by the fourth discussion section. Discussion at the end of the meeting synthesized and identified remaining research needs and priorities. This final discussion began with each working group member sharing a comment, question, or reflection from the work of the group; members were given one minute in round-robin style to answer before the discussion was opened for additional feedback. The panel was challenged to consider the stakeholders best suited to accomplish various recommendations, and whenever possible to strategically prioritize ways in which limited resources can be leveraged for the greatest public good.

Working group members were asked to submit a final version of their individual reflection guides, capturing their identified research needs and priorities, to the co-chairs and NIDCD staff by June 24, 2024.

Research Recommendations

Drs. Dhar, King, Nieman, and Schurman subsequently compiled the research recommendations, which are a consolidation and refinement of recommendations submitted by working group members in their reflection guides; recommendations remaining from prior work identified during pre-meeting activities; and recommendations submitted to NIDCD through the public RFI.

Recommendations were made in 11 areas: Consequences of unaddressed hearing loss; Stigma; Screening and assessment; Care seeking; Care delivery systems; Hearing Care Outcomes; OTC hearing aids; Technology; Economic and policy implications for hearing health care; Workforce; and Overarching Topics.

After the meeting, in an effort to determine emerging research priorities, working group members were asked to select a single recommendation considered of highest priority within each theme in terms of both importance and immediate feasibility. The selected recommendations, which varied considerably among working group members, are noted with an asterisk (*) below.  Any recommendation that received at least one vote is indicated with one asterisk (*). The recommendation that was selected most frequently within each theme is indicated with a double asterisk (**). 

Research recommendations were made in 11 areas:

Consequences of unaddressed hearing loss

• *What are the short- and long-term consequences of unaddressed hearing loss? Which of these are most meaningful to the individual, the family, the community, and the health system?
• How might unaddressed hearing loss affect individual health behaviors, and how does it affect health care delivery?
• *What are the physiological and social consequences of unaddressed hearing loss for the individual, and how can these be addressed?
• *What social-structural factors influence the consequences of unaddressed hearing loss as experienced by individuals, families, and communities?
• *What is the natural history of hearing loss across different populations, and how does this intersect with other factors such as social determinants of health?
• **To what extent does hearing health care mitigate the physical, cognitive, and psychosocial consequences of untreated hearing loss for individuals, families, communities, and society?

Stigma

• *What is the prevalence of different types of hearing loss stigma (experienced, perceived, internalized, secondary) and how does prevalence vary across different groups and across the life course?
• What are the other salient stigmas that intersect with hearing loss stigma for people with hearing loss (including ageism)?
• *How does stigma influence the demand for hearing health care among different communities?
• *What role does stigma play in the utilization of hearing health care services? Does it vary across different groups?
• *What are the sources of hearing loss stigma (e.g., family; community; health care, including primary care; workplace; systems-level) and how do they influence demand for and utilization of hearing health care?
• *What are the sources of support for navigating, mitigating, and challenging hearing loss stigma and how do they influence demand for and utilization of hearing care? For example, do care partners of individuals with hearing loss mitigate or perpetuate stigma?
• *What are the key modifiable drivers of hearing loss stigma? Are aspects of stigma related to hearing health care modifiable? If so, how and for whom?
• How does health literacy affect stigma?
• **What interventions can reduce stigma at different socioecological levels, both at the individual level (individuals with hearing loss, their care providers, or others) and at a health systems level (e.g., integration of stigma assessment and counseling into the hearing health care pathway)?

Screening and assessment

• *What are the outcomes of screening for hearing loss through primary care in asymptomatic adults (e.g., 50 years and older)?  What are the potential benefits and harms at the level of the individual, the provider, and the health care system?
• *To develop accessible paradigms for screening, what are the available technologies?  What are the target populations? Methods should be compared in terms of, e.g., sensitivity and specificity, follow-up rate, appropriateness of different methods for different populations, appropriateness of different health care settings, economics of screenings (insurance, incentives, and disincentives for referrals).
• *What features of hearing screening and assessment drive action in support of hearing health (e.g., prevention, intervention) across different populations?
• Does the setting of hearing screening influence action by the individual?
• **What are barriers and facilitators to integrating hearing screening into various settings?
• *Which assessment measures are most sensitive to an individual’s perception of hearing health care need?
• *Can hearing health status be conveyed in a way that is intuitive to the individual, care partners, and clinicians outside of hearing health care, and that relates to their daily function and quality of life?

Care seeking

• **What internal and external factors influence individuals’ and families' decisions to seek hearing care?
• *How does language and framing around hearing health influence action and care-seeking?
• *What are effective, reliable, and valid means to self-identify hearing difficulties and candidacy for intervention? Which individuals desire and benefit from these?
• *What knowledge, variables, and/or exposures drive individuals to determine that they may benefit from hearing aids?
• *What are the differences and similarities in hearing health care needs and perceptions across different populations?
• What questions, barriers, and opportunities matter most to populations that experience disparities in hearing health care?
• *How does user confusion and uncertainty in selecting an effective pathway or intervention affect decision-making and outcomes? What interventions or resources might mitigate user confusion about hearing care pathways?
• How does trust (e.g., mistrust, high- or low-trust) in hearing health care and health care in general influence hearing care seeking and use among different communities? What are trusted sources and what role can they play in care seeking?
• *What sociostructural barriers and facilitators exist for individuals and families from different communities seeking hearing health care?
• *What is the role of internal/patient-centric barriers in limiting uptake of hearing aids?  These barriers could include unique needs and concerns across the lifespan and among different cultures or special populations.

Care delivery

• Do previous experiences with health care or hearing health care influence future or continued use of hearing care?
• *What factors influence adoption and use of hearing health care across various delivery approaches? Which factors are mutable?
• *What care pathways (e.g., self-care, primary care, pharmacy care, community-based care) are most effective for which populations?
• **Are novel care delivery approaches safe, effective, implementable, and sustainable? Do these approaches improve access? Do they reduce disparities?
• *Which components of service delivery influence uptake and success?
• *How does care setting/delivery approach influence hearing health (including motivation, access, outcomes, satisfaction, etc.)?
• *How can existing but underutilized models of care (e.g., telehealth) be leveraged to improve access and outcomes, and for whom?
• *Can community organizations/faith-based organizations facilitate hearing care?
• *How can existing disparities in hearing health care be addressed through scalable, cost-effective models that reach the most in need? 

Hearing care outcomes

• **What measures capture short- and long-term outcomes of hearing care, and which of these are most meaningful to the individual, the family, the community, and the health system?
• Do instruments that are designed to evaluate hearing health needs and outcomes vary in their efficacy across populations or cultures?
• *How do individual outcomes vary by device-level factors (e.g., price, acoustic quality), care setting, and delivery approach?
• *How can hearing aid users measure and monitor their own hearing health outcomes?
• *How does improved access to hearing health care affect outcomes at the level of communities, health care systems, and society?
• *What is the minimal necessary technology to produce positive outcomes in most individuals?
• Are primary prevention approaches to hearing loss (e.g., safe listening) effective for short- and/or long-term hearing health at an individual level? At a population level?
• *Support and conduct studies, including longitudinal studies, in various populations to better understand the impact of hearing loss and its treatment on health, function, economic productivity, and quality of life.
• *Implement and support a consumer-based metric to enable individuals to understand and track their communication abilities and hearing needs, and a consumer-oriented format for audiograms and other hearing test results.

Over-the-counter (OTC) hearing aids

• *What are short- and long-term outcomes regarding use and self-perceived benefit from OTC hearing aids? Are these driven more by device, delivery approach, or both?
• *Which retail models for OTC hearing aid distribution are most effective and affordable, and for whom?
• **Which consumers require support to successfully navigate the OTC pathway—from selection to fit to extended use—and how can these supports be developed and made broadly available at minimal cost?
• What are the sociodemographic and other predictors of OTC device uptake and success?
• *Can OTC devices be effective in individuals with complex, co-morbid conditions (e.g., cognitive impairment)?
• *What individual characteristics (audiological and other) distinguish the need for less or more personalized levels of intervention (e.g., OTC versus clinician-directed devices)?
• *What follow-up information and patient education components provide maximum benefit to patients with direct-to-consumer hearing aids?

Technology

• *How does individual benefit/satisfaction relate to improving technology? Is it incremental? Does it saturate and, if so, at what point? What is the relationship to cost?
• *When and for whom is a specific technology an enabler or a barrier to accessing hearing health care? Which technologies contribute to the “digital divide” and worsen existing disparities?
• *Can artificial intelligence be leveraged outside of the hearing aid to improve hearing health for the individual and the health care system?
• *Do mobile hearing health applications improve access to and efficacy of hearing health care delivery? Are there minimum standards that need to be met?
• **How can emerging technologies be used to better understand and improve real-world outcomes and satisfaction with hearing-related technology?
• *Can consumer electronics (e.g., audio processing technologies in entertainment devices) be optimized to effectively serve those with hearing loss?
• *What is necessary to generate better hearing aid fitting algorithms and enhanced sound processing algorithms? How might knowledge from tangential fields (e.g., linguistics, computer science, user experience, cognitive science, machine learning, signal processing, wireless technology) inform these efforts?
• Is there a relationship between a device’s electronic capabilities and its physical characteristics (e.g., wearability), and how does this affect uptake?
• *Can technology be leveraged to provide navigational tools that improve an individual’s desire to seek and access hearing health care?
• *The most effective solutions will envision application in broad settings and address a spectrum of issues such as health literacy, rurality, price, adaptability, privacy, and trust.

Economic and policy implications for hearing health care

• **What is the economic return of hearing health care? What is the cost effectiveness of hearing health care?
• *What are reasonable out-of-pocket prices that would increase hearing health care adoption rates?
• *What are the implications for hearing health care of currently enacted legislative policies, both related and tangential to hearing health care? What methods can be used to model and evaluate future potential policies?
• How do third-party reimbursement policies impact individual hearing health care and health care systems?
• *What is the comparative cost-effectiveness of managed care (e.g., audiologists, hearing aid specialists, community health workers) versus consumer-directed care?
• How does the cost per quality-adjusted life years following hearing care intervention compare to that of other medical devices presently reimbursed by third-party payers?
• *What is the economic return on hearing aids measured in terms of workforce participation, reduced unemployment, hours worked, and wages?
• *What benefits of hearing health care influence the willingness to pay by consumers, employers, and third-party payers?
• *What is the cost-effectiveness of early hearing loss identification or hearing loss prevention?
• *What are the immediate and downstream economic impacts of screening for hearing loss in asymptomatic adults?

Workforce

• *Develop and strengthen research training programs to address hearing loss as a public health concern with attention to cross-disciplinary training on sensory disorders, epidemiological methods, advanced biostatistics, and health services and health economics research methods.
• **What existing and emerging workforces can support hearing health care through non-traditional settings and delivery approaches? What training, certification, economic, and policy supports are needed to facilitate task sharing within the hearing health care workforce?
• *Can provider intervention (e.g., training, support) encourage patient-centered care across various populations, and does this affect patient outcomes (e.g., uptake of hearing care)?
• *Professionals with expertise outside of hearing (e.g., methodologists and professionals studying stigma, data science, dissemination and implementation science, economics) should be encouraged to engage in hearing-related research. 

Overarching topics

• *Develop and train in methodologies that generate practical and actionable insights and support the engagement of various communities and populations
• *Develop modernized infrastructure to acquire, harmonize, and access clinical data across sources at large scale to inform science and practice and improve outcomes.
• *In clinical research studies, adequately represent populations that experience health disparities. This will ensure that discoveries are accessible and applicable to those who often face the greatest health challenges, and will avoid the further compounding of existing health disparities.  
• **Strengthen publicly available, evidence-based information that explains hearing and related health concerns to adults of all health literacy levels, and addresses the breadth of services and technologies, including their comparative effectiveness and costs.
• *Interdisciplinary engagement with varied stakeholders and communities in the production and dissemination of hearing-related research.
• *Ensure that interventions (e.g., technology, behavioral, systems-level) are evidence-based, high quality, scalable, and flexible enough to be adapted across different settings.
• Ensure that interventions targeting hearing health disparities are informed by an understanding of underlying mechanism(s), and consider multiple domains and levels of influence. 

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