Funding Opportunity Number: RFA-DC-25-003
Issuing agency: National Institutes of Health, National Institute on Deafness and Other Communication Disorders (NIDCD).
Application deadline: October 1, 2026 at 5:00 PM local time of the applicant organization. No late applications will be accepted.
Funding: NIDCD planned $2 million in FY2027 for this initiative and its companion imaging announcement, subject to annual appropriations. The maximum funding per grant must be less than $500,000 in direct costs per year unless prior approval from NIDCD is obtained. Requests to exceed $500,000 direct costs per year should be made at least six weeks before submission. The maximum project period is five years. Cost sharing is not required.
Purpose: This U01 supports investigator-initiated, high-risk clinical trials developing in vivo high-resolution structural and functional imaging technologies for the living human inner ear. Proposed work should substantially improve current imaging resolution or develop new techniques capable of visualizing inner-ear structures in living humans with greater structural or functional detail.
Clinical-trial scope: Clinical trials are required. The opportunity is intended for trials requiring FDA oversight, trials intended to formally establish efficacy, or trials with potentially higher risks to participants. Applications proposing low-risk trials, more than one clinical trial, or a trial without required milestones and contingency planning are nonresponsive. Lower-risk or non-trial imaging projects should use the companion RFA-DC-25-005 when appropriate.
Eligibility: Eligible organizations include public and private institutions of higher education, nonprofit organizations, small businesses and other for-profit organizations, state and local governments, Tribal governments and organizations, eligible federal agencies and U.S. territories, independent school districts, public and Indian housing authorities, faith-based and community-based organizations, regional organizations, and eligible foreign organizations as specified in the NOFO. Foreign components are allowed subject to current NIH policy. Applicants should review current NIH foreign-collaboration rules carefully before submission.
Submission: Applications are submitted electronically through NIH ASSIST, Grants.gov Workspace, or an institutional system-to-system solution and tracked in eRA Commons. Active SAM/UEI, Grants.gov, and eRA Commons registrations are required.
Atlas assessment: Strong hearing, diagnostic-imaging, medical-device, and translational-clinical relevance, but a credible lead applicant needs advanced inner-ear imaging technology, clinical-trial design and execution capability, regulatory expertise where FDA oversight applies, human-subject infrastructure, quantitative imaging expertise, and institutional research support. Recommended posture: Partner-Led / High-Risk Inner-Ear Imaging Clinical Trial Team. Structural for-profit eligibility does not establish Dr. Miltie direct-prime readiness.
Atlas score: 94/100.