This FOA requests research to increase accessible and affordable hearing health care (HHC). In this context, HHC refers broadly not only to hearing technology but also to the systematic and comprehnsive hearing-related services involved in diagnosis, treatment, auditory rehabilitation, and counseling of individulas with hearing loss, as well as other services that collectively allow the individual to maximize his or her communication outcomes. The overarching emphasis is on the acquisition of knowledge that can be translated into new or enhanced approaches for HHC. Applications should focus on delivering better healthcare access and outcomes and should seek solutions that are effective, affordable, and deliverable to those in need. Research is needed to develop or test new and innovative adaptations of current approaches and practices. These adaptations should be implementable and sustainable in clinical and community practice settings beyond the research environment and may have the potential to address disparities in health care. Research applications may span HHC in the context of a medical model to a psychosocial model of hearing loss. Outcomes research and health services research related to accessible and affordable HHC are also responsive to this FOA. Because some aspects of this research area are new for the NIDCD scientific community, there will likely be a need to obtain preliminary data or conduct early-stage developmental activities before moving to a full-scale project. The Exploratory/Developmental Phased Innovation (R21/R33) grant mechanism is appropriate for this purpose. It provides opportunity for creating, developing, and strengthening new and necessary collaborations, provides opportunity for acquisition of preliminary data, and allows for milestone-driven research, supporting a phased research project with a stepped approach for implementation. Applications not requiring a phased research approach are encouraged to apply under a different funding mechanism (e.g., investigator initiated R21 or R01).
Hearing loss is a major public health issue, and yet it remains a neglected part of most mainstream models of healthcare. In 2015, nearly 7% of the world’s population had disabling hearing loss, a stark uptick from estimates just two years prior. In the United States (U.S.) alone, some 30 million people (13%) have measurable hearing loss, which includes nearly two thirds of individuals aged 70 and older. Recent estimates place the US economic burden of adult hearing loss from lost productivity and excess medical costs in the billions of dollars. Hearing loss has been associated with loneliness, depression, and declining physical function, and there is a growing association linking sensory decline with cognitive faculty and, possibly, dementia. Despite this, most people with hearing loss do not seek or do not receive hearing health care. Since its inception, the National Institute on Deafness and Other Communication Disorders (NIDCD) has prioritized supporting basic and translational research into the normal and disordered mechanisms of hearing and hearing loss, as well as science focused on the care and re/habilitation of persons of all ages with hearing loss. Despite these efforts, little attention was given to systematically exploring hearing health care access, delivery, and affordability. In August 2009, NIDCD convened a working group charged with developing a research agenda to increase accessibility and affordability of hearing health care for adults with mild to moderate hearing loss. The group generated a comprehensive list of research recommendations that identified gaps in evidence-based practice at all levels of the HHC pipeline, for both the consumer and the clinician. This launched a focused and formalized effort from NIDCD to develop a research agenda and portfolio around improving accessible and affordable hearing health care. Following the NIDCD working group, a National Academies of Sciences Engineering and Medicine (NASEM; previously Institute of Medicine IOM) consensus study titled “Hearing Health Care for Adults: Priorities for Improving Access and Affordability”, was published in 2016. At nearly the same time, the President’s Council of Advisors on Science and Technology (PCAST) developed an independent report, “Aging America & Hearing Loss: Imperative of Improved Hearing Technologies”. The overlapping and consistent initiatives and recommendations related to improving hearing healthcare from both non-government and government agencies represented a unique and compelling opportunity for the field. Following these reports, in August 2017, H.R. 2430 was signed into law, which directs the U.S. Food and Drug Administration (FDA) to create a first-of-its-kind category of over-the-counter hearing aids for adults with perceived mild to moderate hearing loss. The field of clinical audiology and auditory rehabilitative science is changing quickly and dramatically, and rigorous scientific research is needed to address the many lingering and new questions surrounding this public health issue. Many of the articulated research needs identified by NASEM and PCAST, in addition to the NIDCD working group, may be appropriate for an Exploratory/Developmental Phased Innovation (R21/R33) grant mechanism to support research and/or infrastructure needs. Addressing the research needs will require increased collaboration among various relevant parties (e.g., researchers, audiologists, hearing aid dispensers, otolaryngologists, primary care physicians, public health researchers, health services researchers, industry, professional and patient-advocacy organizations) as well as infrastructure support and expertise. This FOA is one of several NIDCD research initiatives created in response to the NIDCD working group and NASEM recommendations.
The purpose of this FOA is to encourage research and increase infrastructure support leading to accessible and affordable hearing health care and improved outcomes. This includes research on the development of technologies (e.g., low-cost hearing aids, NIDCD open speech signal processing tools), screening (e.g., effectiveness in typical primary care settings), access and management through new delivery systems (e.g., telehealth, internet, kiosk, convenient care clinics), system barriers (e.g., availability of services, cost, location, insurance coverage, referral network) as well as behavioral research at the individual patient level (e.g., variables influencing one’s perceived need for HHC, patient outcomes). Solutions should be implementable and sustainable in settings beyond the research environment and should have the potential to address disparities in health care. Generally, health disparities populations include racial and ethnic minorities, low socioeconomic populations, conditions with comorbid conditions in addition to hearing loss, and rural populations.
Infrastructure support may include the creation of research partnerships among interested organizations (e.g., academia, practice-based research networks, community-based health care organizations, industry, and professional and patient organizations). It may also include support for creating pooled clinical data sets across institutions, agencies, or health care systems to analyze characteristics of patient populations, provider or health care settings and patient outcomes.
Responsive R21/R33 applications must be milestone-driven and may include, but are not limited to, the following questions and research needs:
- What factors influence a patient’s perceived need for HHC and motivate individuals to seek HHC?
- What are the patient-centered factors that impact access to and outcomes of HHC, including the unique needs and concerns across the lifespan and among different cultures or special populations (e.g., perceived need, personal attitudes, stigma, and socioeconomic status)?
- What are the barriers to accessing the HHC system (e.g., availability of services, cost, availablility of subsidies, complexity, market forces, location, healthcare insurance coverage, and referral network)?
- Do various points of access to HHC (e.g., self-referral, identification by screening program, direct access, referral to HHC professionals) affect outcomes and do these differ for different populations?
- What is the effectiveness of screening in various settings (e.g., primary care offices, community centers, pharmacies, internet screening, convenient care clinics)?
- What are the most effective methods of increasing follow-up rates and uptake of recommended treatments after screening?
- How can effective rehabilitative interventions be successfully delivered in the community?
- What is the minimal technology that will achieve success with hearing aid users?
- What is the difference in outcomes among low cost try-and-select, individually programmed, trainable, and full-feature high-cost devices for varying patient population groups and for individual patients?
- What variables (e.g., technology-centered and patient-centered) predict success, or lack of success, with amplification or other rehabilitative paradigms?
- What follow-up information and patient education components provide maximum benefit to patients with direct-to-consumer (i.e., over-the-counter) hearing aids?
- What are the opportunities to use new health care delivery models, including the internet and telehealth, for HHC?
- How can current delivery systems (including the system and the provider) be modified to increase accessibility and affordability and provide improved outcomes of HHC?
- Develop a consumer-friendly metric of hearing loss that captures perceived functional impairment and allows the consumer to track benefit from intervention(s).
- Develop a low-cost self-testing, self-fitting hearing aid (considering: technology, patient characteristics, selection, fitting and aftercare).
- Develop hearing assistive technology platforms that utilize universal design concepts for the user interface.
- Develop accessible hearing screening paradigms for adults with mild to moderate hearing loss, considering both available technology and target populations.
- Develop research infrastructure supporting research on HHC accessibility and affordability (e.g., databases, practice networks, multidisciplinary teams).
The developmental and/or piloting portion of the research occurs during the R21 phase of the research plan and implementation and/or further research/development occurs within the R33 phase. Transition from the R21 phase to the R33 phase is contingent on successful completion of milestones delineated in the application and is subsequently approved by NIDCD staff (see Section IV.6). At the end of a successful R21/R33, it is expected that there will be measurable and documented advances leading to accessible and affordable HHC. If the application proposes infrastructure development, the organizational structure and information on how investigators will access the support activities must be delineated. Patient access, recruitment services and data collection issues may be included as part of the R21/R33 application.
As an example, in the R21 portion of the application the PD/PI may propose pilot work in which investigators pilot hearing aid fitting using a new delivery system. Upon proof of the feasibility, the R33 phase would provide funds to assist in a research paradigm on a larger population. A second example might be one in which a new technology is developed/or refined. Upon completion of the technology development and readiness (R21 phase), the R33 phase would evaluate the utilization of this tool in a larger clinical population. A third example may be one in which in the R21 phase, questionnaires are developed and piloted addressing barriers to access and utilization of HHC services. Upon completion, the R33 phase would utilize the questionnaire in a research paradigm.
This announcement seeks to encourage outcomes research (also defined as effectiveness research) and/or health services research. Outcomes research seeks to determine to what degree an intervention works in general, real-world settings, such as in diverse populations among varying provider and clinical practice settings. It may also include evaluation of economic impacts linked to health outcomes. This research typically employs broader inclusion criteria, has fewer restrictions for participation and research outcomes, and often includes variables such as functional status, well-being, quality of life, cost, health care resource use, etc. Health services research seeks to examine the impact of organization, financing and management of health care services on the delivery, quality, cost, access to and outcomes of such services. Studies may include research focused on the varying factors that impact access, utilization, quality, and outcomes of HHC.
This FOA also encourages Community-Based Research practices and encourages inclusion and attention to the needs of special populations (e.g., elderly, low socioeconomic status, disparities, rural, second language populations, conditions with comorbid conditions in addition to hearing loss).
This announcement applies only to research applications addressing issues in support of HHC for adults with mild to moderate hearing loss. Studies including individuals with hearing loss greater than mild or moderate (e.g., severe hearing loss) are allowed under this FOA if the project results or outcomes will also have an impact on adults with mild to moderate hearing loss.
Deadline: September 4, 2018 (letters of intent); October 4, 2018, June 4, 2019, February 4, 2020, October 4, 2020, June 4, 2021 (full proposals)
Filed Under: Funding Opportunities