In Vivo High-Resolution Imaging for Inner Ear Visualization (R01 Clinical Trial optional)

The National Institute on Deafness and Other Communication Disorders (NIDCD) has announced the funding opportunity RFA-DC-25-005 titled *In Vivo High-Resolution Imaging for Inner Ear Visualization (R01 Clinical Trial Optional)*. This initiative aims to support the development and advancement of high-resolution structural and functional imaging technologies for the living human inner ear. Research should focus on enhancing imaging resolution, developing innovative imaging techniques, or creating new imaging probes or contrast agents that improve visualization of the auditory and vestibular systems. The ultimate goal is to enable detailed, non-invasive imaging of the inner ear in awake patients within clinical settings, facilitating improved diagnosis, treatment, and understanding of hearing and balance disorders. The scope of this funding opportunity includes developing novel non-invasive imaging modalities, improving existing imaging technologies (e.g., micro-CT, OCT, MRI, fMRI), creating advanced imaging probes or contrast agents, and preparing technologies for clinical translation. Applications must focus on imaging techniques with a clear path toward clinical implementation and must articulate how advancements will improve diagnostic precision and therapeutic approaches. The research may include intermediate studies in mammalian models if they demonstrate a clear translational pathway to human applications. Projects proposing clinical trials must meet NIH-defined low-risk criteria, avoid requiring FDA oversight, and focus on generating scientific evidence to inform future research. Eligible applicants include higher education institutions (both public and private), nonprofit and for-profit organizations, small businesses, state and local governments, Native American tribal entities, foreign organizations, and public housing authorities. Individuals with the requisite expertise are encouraged to apply, with special consideration given to applications from underrepresented groups. Applicants must be registered with SAM.gov, NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov before submission. The NIDCD anticipates funding 4–6 awards across this NOFO and its companion funding opportunity RFA-DC-25-003, with an estimated total budget of $3 million for FY 2025 and $2 million annually for FY 2026 and FY 2027. Individual project budgets must remain below $500,000 in direct costs per year unless prior approval is obtained. The maximum project duration is five years, and application budgets must accurately reflect project needs. Applications must include a detailed project narrative, budget justification, timeline, data management and sharing plan, and research strategy addressing the required five key points: imaging focus, improvement metrics, clinical applicability, diagnostic impact, and treatment potential. Letters of intent are encouraged but not mandatory and should be submitted 30 days before the application due date. The submission deadlines are June 3, 2025, October 1, 2025, June 3, 2026, and October 1, 2026. All applications must be submitted electronically via ASSIST, Grants.gov Workspace, or an institutional system-to-system solution. Applications will be evaluated based on significance, innovation, rigor, feasibility, investigator expertise, and alignment with NIDCD priorities. Proposals must demonstrate a clear plan for clinical translation, address potential limitations, and include a timeline for technology deployment in clinical settings. The scientific merit review will consider the importance of the research, approach, and team capabilities, while programmatic reviews will evaluate alignment with NIDCD goals and budget appropriateness. Awardees will be required to comply with NIH reporting requirements, including annual Research Performance Progress Reports (RPPRs) and final project reports. For technical and administrative inquiries, applicants may contact the designated scientific and financial representatives listed in the funding opportunity.