NIH Highlighted Topic: Advancing Meaningful Outcome Measures in Adult Hearing Care
Below is a brief summary. Please check the full solicitation before applying (link in resources section).
Executive Summary:
The National Institutes of Health (NIH) is seeking innovative research proposals through the SBIR Program focused on advancing meaningful outcome measures in adult hearing care (AHC). NIH is particularly interested in technologies, assessment systems, and data-driven approaches that improve how hearing loss, hearing interventions, and quality-of-life outcomes are measured across clinical and research settings.
Current adult hearing care lacks standardized outcome measures that accurately reflect patient experience, functional hearing ability, and real-world quality-of-life impacts. This limitation has created challenges in evaluating intervention effectiveness, comparing treatment approaches, and building scalable data repositories capable of supporting advanced analytics and personalized hearing care. NIH is encouraging projects that develop, refine, validate, and implement clinically meaningful hearing outcome measures with broad applicability across populations, interventions, and care environments.
Companies developing digital audiology platforms, AI-enabled hearing analytics tools, patient-reported outcome systems, remote monitoring technologies, hearing assessment software, data harmonization platforms, or quality-of-life measurement tools may be strong candidates for funding. NIH is especially interested in projects that improve psychometric rigor, support implementation in low-resource settings, and engage clinicians and patients in real-world care environments.
Through the NIH SBIR Program, U.S. small businesses may apply for up to $323,090 in Phase I funding and up to $2,153,927 in Phase II funding to support research, development, validation, and commercialization activities. Applications are accepted on January 5th, April 5th, and September 5th annually, with funding typically beginning approximately 9 months after submission.
This highlighted topic is supported primarily by the National Institute on Deafness and Other Communication Disorders (NIDCD) and the National Institute on Aging (NIA), both of which may give special consideration to high-impact applications advancing adult hearing care, hearing intervention effectiveness, digital audiology, patient-centered outcomes, and healthy aging technologies.
How much funding would I receive?
Awards provide up to $323,090 for Phase I projects (up to 2 years) and $2,153,927 for Phase II projects (up to 3 years). Some topics approved by NIH may exceed these limits. Fast-Track and Phase IIB (follow-on) options allow continuous or extended funding beyond Phase II.
What could I use the funding for?
Funding may support the research, development, validation, and commercialization of technologies and systems designed to improve outcome measurement and intervention evaluation in adult hearing care.
Eligible activities may include:
Development of standardized outcome measures for adult hearing care interventions
AI and machine learning platforms analyzing hearing outcomes, intervention effectiveness, and patient-reported data
Digital audiology tools supporting hearing assessment, monitoring, and treatment optimization
Quality-of-life measurement systems related to hearing loss and hearing interventions
Remote hearing assessment and teleaudiology platforms
Data harmonization systems and large-scale hearing care repositories
Psychometric validation and refinement of hearing outcome measures
Real-world evidence platforms evaluating hearing aid, pharmaceutical, biologic, and auditory training interventions
Patient engagement technologies supporting personalized hearing care
Clinical workflow integration tools for hearing outcome tracking and analysis
Technologies supporting hearing care implementation in low-resource and underserved settings
Predictive analytics tools for treatment response and hearing health outcomes
Research involving clinician and patient co-design of hearing assessment systems
Translational studies evaluating hearing intervention effectiveness across populations and care settings
Validation studies, prototype development, translational research, and regulatory preparation activities
Commercialization planning and scale-up activities for hearing health technologies and assessment platforms
Funding may also support personnel, software development, clinical data analysis, prototype fabrication, digital health infrastructure, intellectual property protection, commercialization strategy development, and other research and development activities necessary to advance a commercially viable solution aligned with NIH priorities.
Are there any additional benefits I would receive?
Beyond the formal funding award, awardees gain several strategic advantages:
Government Validation and Credibility:
Being selected for an NIH-backed SBIR grant signals technical excellence and alignment with national health and biomedical priorities. This validation builds investor and partner confidence.Enhanced Visibility and Market Recognition:
Awardees are featured in NIH and HHS announcements, helping attract partnerships, media attention, and future contracting opportunities.Access to the Federal Innovation Ecosystem:
Recipients join a national network of researchers and agencies advancing life science innovation, often opening doors to collaborations with NIH laboratories and federal health programs.Stronger Commercial and Exit Potential:
By maturing technology through nondilutive funding, companies strengthen valuation, de-risk commercialization, and increase attractiveness for acquisition or follow-on private investment.
What is the timeline to apply and when would I receive funding?
Applications are accepted each year on January 5th, April 5th, and September 5th. Funding is received approximately 9 months after submission.
Where does this funding come from?
Funding comes from the U.S. Department of Health and Human Services, with statutory set-asides requiring NIH, CDC, and FDA to devote portions of their extramural R&D budgets (3.2% for SBIR, 0.45% for STTR) to support small business innovation.
Who is eligible to apply?
Applicants must be U.S. small business concerns (SBCs) that:
Are organized for profit with a U.S. place of business.
Have ≤ 500 employees including affiliates.
Are > 50% owned by U.S. citizens or permanent residents, qualifying U.S. entities, or combinations thereof.
What companies and projects are likely to win?
Projects that demonstrate:
A clear unmet medical or public-health need,
Strong scientific rationale and feasibility,
High commercialization potential, supported by a realistic market and regulatory strategy, and
Alignment with an NIH Institute’s or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).
Competitive applicants often have an early prototype, preliminary data, and a defined path to market adoption.
Are there any restrictions I should know about?
Companies must complete multiple federal registrations (SAM.gov, Grants.gov, eRA Commons, SBA Company Registry) before applying.
Foreign entities are not eligible.
Disclosure of foreign affiliations and compliance with national security screening are mandatory. Currently we do not recommend any sort of foreign affiliation.
How long will it take me to prepare an application?
For a first-time applicant, preparing a competitive submission will likely take 120–200 hours in total.
How can BW&CO help?
Our team specializes in complex federal R&D proposals and can:
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