SBIR Phase II: Bioengineered Next-Generation Tympanostomy Tubes to Improve Patient Outcomes

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is to improve outcomes for ear tube surgery, one of the most common surgical procedures performed in children, while establishing a scalable manufacturing approach for medical implants made from natural materials. Approximately one million patients in the United States receive ear tubes each year, yet current devices rely on permanent plastics or metals that can cause complications, require repeat procedures, and increase exposure to anesthesia. This project advances a bioengineered ear tube designed to provide effective middle ear ventilation while also enabling safe, on-demand removal without surgery, reducing risk, cost, and burden on families and healthcare systems while improving clinical workflow. Commercially, this work supports entry into a large, established medical device market with an implant that improves safety and efficiency of care. Beyond this initial application, the project establishes a scalable manufacturing foundation for producing complex three-dimensional medical implants from natural materials, addressing a long-standing barrier to broader adoption. Successful completion will enable near term commercialization of next-generation ear tubes while positioning manufacturing for expansion into additional implantable devices, supporting United States leadership in advanced biomedical manufacturing and sustainable healthcare solutions. This Small Business Innovation Research (SBIR) Phase II project advances the development of a next-generation ear tube by combining natural material science with a scalable three-dimensional manufacturing process. The project addresses limitations of conventional ear tubes by developing an implant that maintains ventilation, reduces persistent infection from biofilm formation, and can supports on-demand removal without surgery. Research objectives include optimizing implant design, improving manufacturing consistency, evaluating long-term safety and performance in preclinical models, and generating regulatory-quality data to support future submission to the FDA. The technical approach integrates material characterization, performance testing, and manufacturing scale-up to ensure reproducibility and clinical relevance. Anticipated outcomes include validated ear tube designs with controlled removal capability, and a robust dataset supporting safety and effectiveness. Beyond ear tube technology, the results will demonstrate a manufacturing foundation for producing complex three-dimensional implants from natural materials into medical devices, informing the next class of resorbable or bioengineered implants using sustainable materials. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.