Cooperative Agreement for In Vivo High-Resolution Imaging for Inner Ear Visualization (U01 Clinical Trial Required)
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Jul 16, 2026
Can you apply?
This grant is for research institutions and investigators conducting clinical trials on inner ear imaging technologies. Eligible applicants include academic medical centers, research universities, and NIH-supported research institutions with institutional infrastructure and IRB approval capacity.
The grant requires a clinical trial component as a mandatory element. Researchers must have experience in otolaryngology, audiology, or related clinical fields. Strong institutional support and access to patient populations are essential.
Applicants must be able to manage federal grant compliance, including NIH regulations and human subjects protections. This is a cooperative agreement, meaning significant collaboration with NIH program staff is expected throughout the project period.
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Program description
This funding opportunity aims to support high risk clinical trials for the development of in vivo high-resolution structural and functional imaging technologies for the living human inner ear. Proposed projects should focus on improving the resolution of current imaging techniques or developing new imaging techniques that can visualize inner ear structures in vivo with significantly greater detail and accuracy than currently possible. Structural and functional aspects, including visualizing dynamic elements, are important to developing new and improved techniques. Projects may also focus on developing new imaging probes or contrast agents that can enhance visualization of the inner ear structures. Research supported in response to this RFA is expected to significantly advance the ability to visualize auditory and vestibular components, such as hair cells, otoliths, membranes, ions, and vasculature, in detail in awake patients in a clinical setting using non-invasive techniques. To achieve this goal, a multidisciplinary team approach that takes advantage of the expertise of each team member is highly encouraged. Studies in humans must be proposed to develop,advance, or test the needed technology. Any intermediate studies must articulate a clear path of the proposed methodology to application in awake humans or define the limitations and the usefulness in anesthetized humans.
Who can apply
Eligible applicants
How to apply
Application links
Required documents
- SF-424 (Application for Federal Assistance)
- Project Narrative and Specific Aims
- Research Strategy (Significance, Innovation, Approach)
- Budget and Budget Justification
- Biographical Sketches (Key Personnel)
- Facilities and Administrative Resources
- Letters of Support
- IRB Approval or Approval Timeline
- Clinical Trial Protocol (if available)
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.173 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
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$67,501,043
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$41,811,330
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$29,666,573
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$25,009,162
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$22,883,624
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$22,740,456
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$16,596,227
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$13,760,149
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$12,363,350
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$12,276,804
Top States by Funding
- MA 11 awards $143.1M
- CA 10 awards $101.6M
- IA 5 awards $77.5M
- CT 2 awards $76.3M
- MD 8 awards $65.0M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.173). How funding has trended year over year.
| 2024 | $422,034,489 | |
| 2025 | $422,700,014 | |
| 2026 est. | $427,030,000 |
FAQ
Who can apply for this cooperative agreement?
Academic medical centers, research universities, and NIH-funded institutions with clinical trial infrastructure can apply. You need IRB approval capacity and experience managing human subjects research.
Is a clinical trial required?
Yes, the U01 mechanism requires a clinical trial component. Your research must involve human subjects and comply with all human subjects protection regulations.
What is a cooperative agreement and how does it differ from a standard grant?
A cooperative agreement requires ongoing collaboration with NIH program staff. Expect regular communication and may need to adjust your research direction based on NIH guidance.
How competitive is this funding?
NIH clinical trial grants are highly competitive. Strong preliminary data, experienced teams, and clear innovation are essential. Plan to address reviewer concerns about feasibility and patient recruitment.
What is the typical funding range?
Funding varies based on research scope and infrastructure needs. Budget should reflect realistic clinical trial costs including patient recruitment, imaging equipment, and regulatory compliance.
💡 Tips for applicants
- Emphasize preliminary data on your imaging approach. Show proof-of-concept before submitting the application.
- Clearly identify your clinical trial design and patient recruitment strategy. Reviewers need confidence you can enroll and retain participants.
- Detail your IRB and regulatory plan. Describe how you'll meet NIH human subjects protections requirements.
- Highlight your team's clinical expertise alongside technical imaging knowledge. Balance is critical for success.
- Address feasibility directly. Explain why your institution can realistically complete this clinical trial within budget and timeline.
⚠️ Common mistakes
Insufficient preliminary data or weak proof-of-concept for the imaging technology. Vague or unrealistic clinical trial design without detailed patient recruitment strategy. Lack of clear institutional commitment or weak IRB/regulatory infrastructure plan.
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