Key Dates

Related Announcements

• May 7, 2020 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed). See NOFO PA-20-195.

Issued by

National Institute on Deafness and Other Communication Disorders (NIDCD)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Research on Women's Health (ORWH)

Purpose

The intent of this Notice of Special Interest (NOSI) is to promote research to better understand autoimmune inner ear disease (AIED); also known as autoimmune-associated sudden sensorineural hearing loss (SSNHL). The overall goal is to identify strategies to prevent and treat this disease.

Background

Autoimmune inner ear disease (AIED) is an inflammatory disorder of the inner ear. It typically presents with unilateral sudden sensorineural hearing loss that can rapidly progress to involve the second ear. The sudden hearing loss may be fluctuating or progressive. AIED may be seen as a primary autoimmune disease, or secondary to other autoimmune diseases including granulomatosis with polyangiitis, Cogan syndrome, rheumatoid arthritis, systemic lupus erythematosus, polyarteritis nodosa, vitiligo, and relapsing polychondritis.

While AIED is often associated with elevated inflammatory markers and may be associated with autoantibodies such as antinuclear antibodies (ANA), rheumatoid factor (RF), and the anti-cochlear antibody 68 kilodalton protein (68kD, hsp-70 antibody), diagnostic and prognostic biomarkers for AIED are very limited.

Similarly, while AIED is often responsive to high dose glucocorticoids with some recovery of hearing, steroid use long-term carries significant side effects, and tapering may result in recurrence. While some cytotoxic and steroid-sparing agents have shown efficacy in AIED, a randomized trial of methotrexate found no benefit when used as a steroid-sparing agent in patients who had experienced hearing improvement after one month of prednisone use.

In 2022, the National Academies of Sciences, Engineering, and Medicine report, Enhancing NIH Research on Autoimmune Disease, examined NIH research efforts related to autoimmune diseases. Subsequently, Congress, via the Joint Explanatory Statement accompanying the Fiscal Year 2023 Consolidated Appropriations Act, directed the establishment of the Office of Autoimmune Disease Research in the Office of Research on Women’s Health (OADR-ORWH) and instructed the office to:

• Coordinate development of a multi-institute and center (IC) strategic research plan
• Identify emerging areas of innovation and research opportunity
• Coordinate and foster collaborative research across ICs
• Annually evaluate the NIH autoimmune disease research portfolio
• Provide resources to support planning, collaboration, and innovation
• Develop a publicly accessible central repository for autoimmune disease research

AIED is an area of portfolio interest to OADR and NIDCD. Working in collaboration with OADR-ORWH, NIDCD is interested in supporting AIED research as part of the growing autoimmune disease research portfolio.

Research Objectives

This NOSI calls for research applications to investigate AIED/SSHL. Research may include any of the following areas:

• Epidemiologic research into the association with exposures that may contribute to risk of AIED
• Research focused on understanding the mechanisms of immune and/or autoimmune pathways that contribute to hearing impairment and AIED
• Research investigating antigens and epitopes that may drive the pathogenesis of AIED
• Research focused on genomics, epigenomics, transcriptomics, proteomics, and metabolomics to identify risk and susceptibility factors for developing AIED and/or relapsing after initial treatment response
• Research focused on identifying predictive, prognostic, and/or diagnostic biomarkers of AIED
• Research investigating the role of the microbiome and virome in the inception and flare of AIED
• Research investigating the interplay of environmental, social (e.g., race, ethnicity, gender), and other internal and external exposures, including social determinants of health, on inception and flare of AIED
• Research focused on improving immunotherapeutic approaches for AIED
• Research investigating novel therapeutic agents for AIED as well as research on novel mechanisms for drug delivery in AIED
• Research focused on long term outcomes from AIED
• Research focused on the influence of sex specific factors (e.g., steroid hormones, sex chromosomes) in the development, progression and outcomes of AIED

Potential applicants are encouraged to speak with the NIDCD and OADR Scientific/Research contacts listed below to discuss the relevance of the proposed research topic(s).

Responsiveness

This NOSI calls for research projects to study AIED. Research focused on other causes of SSNHL is not responsive to this NOSI. 

Application and Submission Information

This notice applies to due dates on or after February 16, 2025 and subsequent receipt dates through October 17, 2027. 

Submit applications for this initiative using one of the following notice of funding opportunity (NOFO) or any reissues of this announcement through the expiration date of this notice.

• PA-20-195 NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)

All instructions in the How to Apply - Application Guide and the notice of funding opportunity used for submission must be followed, with the following additions:

• For funding consideration, applicants must include “NOT-DC-25-003” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.

Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.

Inquiries

Please direct all inquiries to the Scientific/Research, Peer Review, and Financial/Grants Management contacts in Section VII of the listed notice of funding opportunity.

Scientific/Research Contact(s)

Bracie Watson, Ph.D.
Program Director
Division of Scientific Programs
National Institute on Deafness and Other Communication Disorders (NIDCD)
Email: watsonb@nidcd.nih.gov

Victoria Shanmugam, MBBS, MRCP, FACR, CCD
Director of the Office of Autoimmune Disease Research (OADR)
Office of Research on Women’s Health (ORWH)
E-mail: OADRInfo@nih.gov

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Samantha Tempchin
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-435-1404
Email: samantha.tempchin@nih.gov