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Cooperative Agreement for In Vivo High-Resolution Imaging for Inner Ear Visualization (U01 Clinical Trial Required)

US National Institutes of Health (NIH) — National Institute on Deafness and Other Communication Disorders (NIDCD) grant open #RFA-DC-25-003
Response due Oct 01, 2026 · 00:00 UTC

Summary

The National Institutes of Health (NIH) is soliciting cooperative agreement applications (U01 mechanism) to support research on in vivo high-resolution imaging techniques for visualization of the inner ear. This opportunity requires a clinical trial component, indicating the funded work must involve human subjects. The program aims to advance non-invasive or minimally invasive imaging modalities capable of resolving inner ear structures in living subjects. As a cooperative agreement, NIH program staff will have substantial programmatic involvement in the funded projects.

What they want

Applicants must propose and conduct research developing or applying in vivo high-resolution imaging technologies for inner ear visualization. The work must include a clinical trial as a required component. NIH will engage substantively with awardees through the cooperative agreement mechanism (U01), providing programmatic guidance and oversight throughout the project period.
Deliverables
  • Clinical trial data on in vivo inner ear imaging in human subjects
  • High-resolution imaging protocols for inner ear visualization
  • Progress reports and data sharing per NIH cooperative agreement terms
  • Publications and dissemination of research findings
Technical requirements
  • Clinical trial required — proposals must include a human subjects clinical trial component
  • In vivo imaging methodology targeting inner ear structures
  • High-resolution imaging capability must be demonstrated or proposed for living subjects
  • Cooperative agreement mechanism (U01) — NIH program staff will have substantial involvement
Key personnel
  • Principal Investigator (PI) with demonstrated expertise in biomedical imaging and/or otology
  • Clinical trial coordinator or co-investigator with human subjects trial experience

How they evaluate

  • Scientific and technical merit (reviewed by NIH study section)
  • Significance and innovation of imaging approach
  • Investigators' qualifications and experience
  • Clinical trial design rigor and feasibility
  • Environment and institutional resources
  • Approach and methodology
Submission: Electronic submission via Grants.gov federal grants portal

Eligibility & certifications

SAM.gov registration (federal grants requirement)IRB approval or documentation for clinical trialHuman subjects protections compliance (45 CFR 46)NIH Grants Policy Statement compliance

Risks & flags

  • Extremely long open window (nearly 2 years, Jan 2025–Oct 2026) — may indicate rolling receipt dates or multiple submission cycles rather than a single deadline; actual due dates for individual receipt cycles not specified in the source text
  • RFA number (RFA-DC-25-003) indicates NIDCD-specific funding opportunity, which may limit competitive field to a narrow set of specialized academic medical centers with existing inner ear imaging infrastructure
  • Clinical trial requirement significantly narrows eligible applicants to those with existing clinical infrastructure and IRB-ready protocols

Market context

inferred from NAICS
Professional, Scientific & Technical Services
NAICS 541711
US market size
$2.0T
Typical award
$25K – $50M
Typical buyers
All federal civilianDoDStates
Commonly required
8(a)WOSBSDVOSBPE/PMP

Sector-level estimate — full code lookup not yet in catalog.

Cooperative Agreement for In Vivo High-Res…
Due Oct 01
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