The Cooperative Agreement for In Vivo High-Resolution Imaging for Inner Ear Visualization (U01 Clinical Trial Required), funded by the National Institute on Deafness and Other Communication Disorders (NIDCD) under the National Institutes of Health (NIH), supports clinical trials aimed at advancing imaging technologies for the human inner ear. The primary objective is to improve or develop imaging techniques that offer significantly enhanced structural and functional visualization of inner ear components, including hair cells, otoliths, membranes, and vasculature, in awake patients using non-invasive methods. These advancements are expected to directly inform clinical diagnoses, interventions, and treatment strategies for auditory and vestibular disorders.

This funding opportunity focuses on high-risk clinical trials requiring FDA oversight, those intended to formally establish efficacy, or those posing higher risks to participants. Projects may include the development of novel imaging technologies, enhancements to existing imaging methods such as micro-CT, MRI, or super-resolution microscopy, and the creation of innovative imaging probes or contrast agents. Proposed research must demonstrate a clear pathway for clinical application, particularly in awake humans, with well-defined plans for feasibility, translation, and anticipated clinical benefits.

The funding scope provides support for up to $500,000 in direct costs per year, with a maximum project period of five years. Applicants proposing budgets exceeding $500,000 annually must secure prior approval from NIDCD at least six weeks before the submission deadline. Approximately $3 million is anticipated for FY2025, supporting 2-4 awards, including companion funding opportunities under RFA-DC-25-005.

Eligible applicants include higher education institutions, nonprofit and for-profit organizations, small businesses, state and local governments, federally recognized tribal governments, and foreign organizations. Collaborative, multidisciplinary team approaches are encouraged, and all applicants must adhere to the NIH's registration and compliance requirements, including System for Award Management (SAM) and eRA Commons registration.

Applications will be evaluated based on criteria including significance, innovation, rigor, feasibility, and expertise of the research team. Specific emphasis will be placed on the extent to which the proposed imaging advancements address current technological limitations, improve clinical diagnostic capabilities, and demonstrate a clear pathway for translation into standard clinical practice. The inclusion of underrepresented populations in clinical trials, as well as detailed milestone plans and contingency strategies, is also required.

Applicants must submit a letter of intent 30 days prior to the application due date. Key submission deadlines include June 3, 2025, and October 1, 2025, with subsequent deadlines scheduled through October 2026. Awards are anticipated to begin in March 2026 for the June 2025 cycle. Applications must be submitted via Grants.gov or the NIH ASSIST system, and compliance with the NIH Data Management and Sharing Policy is mandatory.

Awardees are expected to participate in Data and Safety Monitoring Boards (DSMB), comply with ClinicalTrials.gov registration and reporting, and engage in periodic progress reviews with NIH staff. Regular updates, adherence to milestones, and timely reporting are essential components of award management. For detailed application guidance, applicants are strongly encouraged to contact Dr. Amy Poremba (Scientific/Research Contact) or other listed NIH representatives well in advance of submission.