RFA-DC-25-005: In Vivo High-Resolution Imaging for Inner Ear Visualization (R01, Clinical Trial Optional)

RFA-DC-25-005: In Vivo High-Resolution Imaging for Inner Ear Visualization (R01, Clinical Trial Optional)

This page is a historical reference to NIH Notice of Funding Opportunity RFA-DC-25-005, administered by the National Institute on Deafness and Other Communication Disorders (NIDCD), part of the National Institutes of Health. The notice supported development of in vivo, high-resolution structural and functional imaging for the living human inner ear, especially approaches that could show auditory and vestibular structures in awake humans with substantially greater detail or accuracy than then-current methods. It is closed: the final listed application receipt date was October 1, 2026, and the notice expired October 2, 2026. The official listings disclose no later receipt date or successor round. No applications can be submitted under this expired notice.

The October 1, 2026 receipt date was the final date listed in the notice, with a 5:00 PM local-time cutoff for the applicant organization. NIH stated that late applications would not be accepted. The notice expired on October 2, 2026. These dates document the closed cycle; they are not an open or rolling application window. Anyone planning a future submission should locate a newly issued NIDCD announcement and use that announcement’s terms rather than relying on this archived notice.

Key details at a glance

What this opportunity funds and what it explicitly does not fund

This NOFO is a targeted imaging opportunity, not a general funding stream for auditory health work. The supported work should address structural or functional imaging of the human inner ear and should explain how the proposed method can reach human use. Responsive projects can include:

• Development of new non-invasive in vivo techniques with materially improved spatial, temporal, or functional resolution in humans.
• Improvement of existing methods (hardware/software/protocol-level upgrades) to increase signal quality, contrast, and diagnostic power.
• Development of imaging probes and contrast agents to visualize inner-ear structures.
• Translation-focused work that moves an imaging method toward non-invasive use with awake humans in a clinical setting.

The notice also allows studies in humans and intermediate studies in mammalian animal models. An animal or anesthetized-human study must explain its path toward awake-human application, or clearly state its limitations and usefulness. A multidisciplinary team is encouraged when the project needs complementary imaging, engineering, biological, and clinical expertise.

The program explicitly emphasizes structure and function where prior methods are insufficient and where imaging can materially improve diagnosis and care pathways for hearing, balance, and related communication disorders.

It is not meant for a broad diagnostic platform with no credible inner-ear application. The NOFO says that the following are not responsive:

• Proposals without realistic translation to imaging inner ear structures in humans.
• Non-mammalian work disconnected from human relevance.
• High-risk clinical trials.
• Applications proposing more than one clinical trial in a single submission.
• Applications that omit the required five-point Research Strategy structure.

The five required points are substantive application instructions, not optional suggestions:

1. Specify what imaging dimension is improved (spatial, temporal, or functional).
2. Quantify likely resolution increase and explain clinical impact.
3. Give a timeline and detailed plan for taking the work into a clinical setting for non-invasive use with awake humans. If the method can only be used invasively, in anesthetized humans, or in animals, explain its limits and possible translation solutions.
4. Describe the clinical settings and conditions in which the technique could be used, how it would inform care and management, and how it could guide clinical decisions.
5. Describe the auditory or vestibular pathologies that could be better diagnosed and any treatments that could be informed by the improved imaging.

If your idea does not clearly satisfy these, the application is likely to fail before scoring.

Clinical-trial boundary and relationship to the companion U01

The companion opportunity is the U01 (RFA-DC-25-003) for high-risk clinical trials. RFA-DC-25-005 may include one NIH-defined clinical trial, or no trial, but a proposed trial must satisfy every condition in the notice. It must be low risk to participants, not require FDA oversight such as an IND or IDE, not be an NIH-defined Phase III trial, and be intended to gather scientific evidence for later studies rather than directly change health policy or the standard of care.

From the NOFO language, this distinction is operational, not just semantic:

• Allowed: a low-risk human imaging trial that is hypothesis-driven and produces data needed for later scientific, design, implementation, or clinical work.
• Allowed: a non-trial imaging project involving humans or mammalian intermediate studies when the research is relevant to the NIDCD mission and has a credible human-use path.
• Excluded: a trial needing IND or IDE oversight, a high-risk trial, a Phase III efficacy study, or an application containing more than one clinical trial.

In practice, if your proposal needs regulatory-heavy risk management, adverse event complexity, or direct treatment claims, it likely belongs in a different NOFO, and you should use this one only if the technical objective remains fundamental imaging development.

Who is eligible and who should treat this as high-risk for scope

Eligibility is broad by NIH standards. The NOFO lists the following eligible organization categories:

• public and private institutions of higher education,
• nonprofits (including 501(c)(3) and non-501(c)(3)),
• for-profits including small businesses,
• local government entities,
• federal government entities,
• tribal and regional organizations in eligible categories,
• independent school districts, public housing authorities, Native American tribal organizations, faith- or community-based organizations, regional organizations, and foreign organizations.

Foreign organizations and foreign components of U.S. organizations are eligible under this NOFO. The notice also states that NIH will not issue awards involving foreign subawards or subcontracts unless the NOFO is specifically designated for funded international collaborations. That distinction matters for a proposal whose international work would require a funded subaward.

The applicant organization must complete and maintain the required registrations before submission. The notice warns that registration can take six weeks or more, and that an incomplete registration is not a valid reason for a late application. The main gates are:

1. Organization registration: maintain active System for Award Management (SAM) registration and complete Grants.gov registration. The organization must also have the required unique entity information and eRA Commons affiliation.
2. PI and role setup: every PD/PI needs an eRA Commons account, and the PD/PI profile must be linked to a valid ORCID ID. If one person serves as both PD/PI and Signing Official, NIH requires distinct eRA Commons accounts for those roles.
3. Clinical-trial classification: decide early whether participants are prospectively assigned to an intervention. If the answer is yes, the application must include the required human-subjects and clinical-trial information.
4. One-trial limit: include no more than one clinical trial, and verify every low-risk condition before the application is submitted.

The NOFO itself is explicit that applications with registration gaps are at risk of late submission and do not receive waiver discretion.

Funds, budget logic, and the direct-cost limit

The official award section gave the closed notice a program-level planning figure and a per-grant budget rule:

• NIDCD intends to commit $3M in FY 2025 for 4–6 awards combined across this NOFO and the companion RFA-DC-25-003.
• Future-year amounts depend on annual appropriations, with $2M planned in both FY 2026 and FY 2027.
• Maximum funding per grant must be less than $500,000 in direct costs per year unless NIDCD prior approval is obtained.

For applicants in that cycle, the terms made scientific fit and technical execution more relevant than pursuing the largest possible budget.

The notice specified that:

• the budget was to reflect the actual needs of the proposed project;
• a request at or above the threshold required advance contact and prior approval from NIDCD; and
• the period of support was based on project scope, up to a maximum of five years.

The project period was not fixed; it was determined by scope up to a maximum of five years. For proposals in the closed cycle, a phased imaging roadmap still needed a realistic staffing and facility plan tied to publication and validation milestones.

Historical application timeline and process

The official table contains four receipt dates for the reissued notice:

• June 3, 2025, followed by November 2025 scientific merit review, January 2026 advisory council review, and March 2026 earliest start.
• October 1, 2025, followed by March 2026 scientific merit review, May 2026 advisory council review, and July 2026 earliest start.
• June 3, 2026, followed by November 2026 scientific merit review, January 2027 advisory council review, and March 2027 earliest start.
• October 1, 2026, followed by March 2027 scientific merit review, May 2027 advisory council review, and July 2027 earliest start.

The October 1, 2026 row was the last receipt date in the published schedule. The notice expired October 2, 2026, and no later date appears in the official listing. This schedule is retained here as a record of the completed round, not as an upcoming application opportunity.

Review and award cycles in the NOFO key-date table pair each full submission set with likely peer review, council review, and earliest start windows through 2027.

What applicants needed to do for the closed round

For the closed round, applicants had to plan backward from the October 1, 2026 receipt date. The sequence below describes the requirements of that notice and is not a live submission checklist:

• First: applicants defined whether the project was a clinical trial and whether it met the low-risk criteria. NIDCD encouraged early contact if classification, scope, or the budget threshold was uncertain.
• Next: applicants set measurable imaging targets, identified the clinical setting, and built the five-point Research Strategy around the path to awake-human use.
• Before drafting: SAM, Grants.gov, eRA Commons, unique-entity, ORCID, and any applicable foreign-organization registrations needed to be complete before submission.
• During assembly: applicants prepared the SF424 (R&R) components, Research Plan, human-subjects or clinical-trial records when applicable, Data Management and Sharing Plan, and other required resource-sharing materials.
• Before submission: applicants checked page limits, application-type restrictions, budget justification, and institutional submission authority, then reviewed the submitted application in eRA Commons and corrected errors by the deadline.

NIH explicitly expects early submission to reduce late-stage submission errors.

Submission systems and route

The NOFO accepted three electronic routes:

• NIH ASSIST.
• An institutional system-to-system solution.
• Grants.gov Workspace.

Applicants accessed the package through one of those routes. After submission through Grants.gov, they tracked the application in eRA Commons, reviewed it before the due date, and corrected errors in time. The notice warned that applications that did not conform to its instructions or the NIH Application Guide could be delayed or not accepted for review.

Required materials and what the reviewers will look for

The NOFO’s review emphasized translation feasibility over generic imaging claims.

Required core sections

• Standard NIH SF424(R&R) forms and profile sections.
• Full response to the five required points in the PHS 398 Research Plan’s Research Strategy.
• A specific plan for clinical translation and the conditions of use in awake humans, or a justified explanation of limitations if the work cannot yet reach that setting.
• A Data Management and Sharing Plan when the research will generate scientific data.
• Resource-sharing plans as required by the NIH Application Guide.
• Human-subjects and clinical-trial records when the project involves those activities.
• Vertebrate-animal, biohazard, inclusion, and other attachments when applicable.

Clinical trial posture (if included)

If your application includes a human trial component, make sure all NIH criteria are explicitly satisfied:

• No FDA oversight such as an IND or IDE is required.
• The intervention is low risk to participants.
• The trial is not an NIH-defined Phase III study intended to establish efficacy.
• The study gathers evidence to inform later work rather than directly changing health policy or the standard of care.
• At most one clinical trial appears in the application.

Any proposal that sounds like efficacy proof in this pathway should not proceed under this NOFO.

Compliance and policy anchors

Beyond NIH science review, successful submission requires attention to:

• SAM.gov validity and UEI alignment.
• eRA Commons role setup for PD/PI and signing official.
• Institution-level submission authority alignment.
• Data and safety requirements for clinical work.
• ClinicalTrials.gov registration posture for applicable trials.

Skipping these does not usually disqualify by science but can fail intake and delay review.

Review criteria and how to strengthen a submission

NIH evaluates applications through scientific and technical peer review, followed by a second-level review by the appropriate Advisory Council or Board. For this NOFO, the application should make four things easy for reviewers to judge:

• Specificity of imaging gain: state whether the improvement is spatial, temporal, functional, or a combination, and quantify the expected change against current techniques.
• Feasible translational bridge: define where in the clinic this improves decisions.
• Team sufficiency: combine technical and clinical expertise.
• Scope control: avoid trying to do full productization, diagnostics, and broad commercial translation in a single grant year.

Section V applies NIH’s review factors and topic-specific checks:

• Innovation is not enough alone; impact requires a clinical pathway.
• Rigor in study design, safety handling, and reproducibility.
• If human subjects are included, review considers risk control, inclusion, protections, and data validity.
• For vertebrate work, methodologic and welfare standards are weighted.

Reviewer traps to avoid

• Submitting a high-risk intervention plan under the low-risk NOFO.
• Confusing this NOFO with the companion U01 clinical trial arm.
• Omitting one of the five required Research Strategy points.
• Underestimating time needed for registrations and account setup.
• Over-promising translational outcomes without a realistic clinical workflow.

Projects that stay disciplined on technical novelty and clinical value, and that explain how data will drive diagnosis or treatment planning, usually resonate better than broader “imaging tool” proposals.

Common mistakes recorded for the closed cycle

The following checklist summarizes what applicants needed to verify before the final receipt date. It cannot be used to submit under this expired notice:

• The final receipt date was October 1, 2026, with a 5:00 PM local-time cutoff.
• Applicants chose a non-trial project or a qualifying low-risk clinical trial.
• Applications containing a trial included no more than one.
• Proposed work directly targeted human inner-ear imaging rather than generic imaging.
• Applicant organizations and PD/PIs completed NIH registration requirements (SAM, UEI, eRA Commons, and Grants.gov).
• Applications included applicable data management, resource sharing, safety, and human-subjects plans.
• Grant budgets stayed below $500,000 in direct costs per year unless NIDCD prior approval was obtained.
• Proposed milestones were linked to grant-year activities and spending.
• Applications described translation pathways and diagnostic context.

For the closed cycle, the distinction from RFA-DC-25-003 was the risk and trial design: this R01 allowed no trial or one qualifying low-risk trial, while high-risk trials, trials requiring FDA oversight, and NIH-defined Phase III trials belonged outside its scope. Teams considering a future application should check the status and terms of both notices afresh.

Frequently Asked Questions

Is this still open for applications?

No. The final listed receipt date was October 1, 2026, and the notice expired October 2, 2026. The published review and earliest-start dates belong to applications already submitted under that round. No next round is announced in the official listing.

Did this notice support human research?

Yes. The closed notice supported non-trial work and allowed one NIH-defined clinical trial if it met all low-risk conditions. A trial requiring FDA oversight, a high-risk trial, or a Phase III trial was outside this R01’s scope.

Were foreign groups eligible?

Yes. Foreign organizations and foreign components of U.S. organizations were listed as eligible in the closed notice, subject to NIH registration and application requirements. NIH policy separately restricted foreign subawards and subcontracts unless a NOFO was designated for funded international collaborations.

Was this a one-year award?

No. The project period was determined by scope and could be up to five years.

Did applications need resource-sharing and data-management plans?

The closed notice required applicants to follow the NIH Application Guide and include the applicable plans. Requirements depended on the proposed research and NIH policies in effect for that application.

Is the funding guaranteed at $2M per year?

No. The $2 million figures for FY 2026 and FY 2027 were planned amounts, and the notice said future-year funding depended on annual appropriations. Under that notice, a per-grant budget had to reflect project needs and stay below the direct-cost limit unless NIDCD approved otherwise.

Official links and monitoring

Official Grants.gov opportunity listing (archived notice): https://simpler.grants.gov/opportunity/056e3a67-1026-4330-a98d-dad49975a09d

The NIH/NIDCD full announcement remains available at: https://grants.nih.gov/grants/guide/rfa-files/RFA-DC-25-005.html

Related companion opportunity (higher-risk clinical trial path): https://grants.nih.gov/grants/guide/rfa-files/RFA-DC-25-003.html

NIH application guidance references are in the same source, including submission contacts and instructions pages in the NOFO.

The published dates and terms above document the expired notice. No next round is announced in the official listing. Check NIDCD and Grants.gov for a new announcement before planning or preparing any future application.