First-in-Human (FIH) Clinical Studies

The contract involves conducting first-in-human clinical studies with a minimum of six hearing-impaired patients to assess the safety, efficacy, and speed at which a neuroprosthetic system can be personalized for individual users. This research is aimed at generating critical data on the device’s performance and adaptability in a real-world clinical setting. The studies will be carried out in Washington under the auspices of the Advanced Research Projects Agency for Health (ARPA-H), which operates within the Department of Health and Human Services. The contract is classified as a subcontract with a NAICS code of 621399, indicating it falls within medical and diagnostic laboratory services. The solicitation was posted in early May 2026, with proposals due by mid-August 2026. Although no specific set-aside type or organization specification is mentioned, the project represents a significant step toward advancing innovative neuroprosthetic solutions for hearing impairment, focusing on personalized treatment approaches and ensuring patient safety throughout the trial process.