Qualia Oto has been awarded a Phase I Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH), specifically the National Institute on Deafness and Other Communication Disorders, totaling more than $304,000 over the next 12 months. The project, titled “Robotic-Inserted, Shape-Conforming Cochlear Implant Electrode Arrays,” aims to validate the company’s novel shape-memory polymer (SMP) technology and its performance when inserted via robotic assistance.
The research will be conducted in collaboration with Dr. Hongbing Lu at the University of Texas at Dallas and iotaMotion, whose iotaSOFT® Insertion System is currently the only commercially available robotic-assisted cochlear implant insertion system in the United States.
“The benefits cochlear implants provide are remarkable. However, there is always the risk that something can go wrong during the early stages of implantation. Here at Qualia Oto, we are developing technologies to minimize this risk and improve patient outcomes. This Phase I SBIR will allow us to take these technologies even farther by providing controlled, precise insertion speed of the implant into the cochlear via robotics. I am very excited to see where this technology can go and to continue to pioneer breakthrough technologies in the world of auditory restoration.”
–Dr. Benjamin Lund, Chief Technology Officer
Robotic Precision and Shape-Adaptive Materials
The project includes two main objectives. First, Qualia Oto will continue to demonstrate the effectiveness of its shape-memory polymer technology, which enables cochlear implant electrode arrays to self-curl and conform during insertion. Improving the consistency and scalability of SMP manufacturing remains a critical focus for future commercialization.
Second, the study will examine the potential advantages of robotic-assisted insertion, which offers controlled and consistent electrode placement at speeds as slow as 0.1 mm/s—up to 90% slower than manual techniques. Slower, uniform insertions are believed to reduce trauma to the cochlea. iotaMotion’s iotaSOFT® system will be used to deliver this precise control and enable a novel integration of robotics with Qualia Oto’s SMP-based electrode arrays.
Qualia Oto is collaborating with Dr. Hongbing Lu at the University of Texas at Dallas and iotaMotion, whose iotaSOFT® Insertion System remains the only commercially available robotic-assisted cochlear implant insertion system in the U.S.
“I am excited to receive this award,” said Dr. Jimin Maeng, Senior Research Engineer at Qualia Oto. “This funding, alongside our prior SBIR awards, shows how well-recognized our novel cochlear implant electrode technology is. Through previous projects, we have successfully demonstrated shape-adaptive electrode arrays can enable coincident atraumatic insertion and favorable electrode positioning in the cochlea, addressing the longstanding challenge in the field. This new project will provide the opportunity to validate that our electrodes, when assisted by robotic insertion, can further minimize the insertion trauma and optimize the placement with high accuracy and high repeatability. I am keen to see promising results from this research, which we envision will ultimately lead to a paradigm shift in the field of cochlear implants.”
Computational Modeling to Support Clinical Translation
Dr. Hongbing Lu will oversee the subaward at UT Dallas. His lab will focus on computational modeling and experimental observation to help identify optimal SMP formulations and implant design. These efforts include the development of a digital twin validated by in-situ x-ray computed tomography to achieve uniform perimodiolar electrode placement.
“We look forward to working with Qualia Oto on this novel project,” noted Dr. Lu. “Our team will use computational modeling and experimental observation to identify the suitable material formulation of the shape-memory polymer and the design configuration of the cochlear implant. Then, we will couple the optimal combination of SMP formulation and design with the proper insertion protocol to lead to uniform perimodiolar placement of the array. These will be accomplished by characterization of the shape fixity and recovery behavior of the SMP, and implementation of a digital twin, validated by in-situ x-ray computed tomography to achieve a uniform, conformal coverage on the modiolar wall. We are enthusiastic about the potential this new approach brings.”
According to the World Health Organization, over 430 million people worldwide experience disabling hearing loss—a number projected to exceed 700 million by 2050. In the United States alone, approximately 15% of adults report hearing difficulties. With demand for cochlear implants increasing alongside global population aging and technological innovation, projects like this aim to improve outcomes and support safer, more effective hearing interventions.
This Phase I grant not only advances Qualia Oto’s research and development but also lays the groundwork for a potential Phase II grant and future clinical application of their robotic-assisted, shape-conforming cochlear implant technology.
About the NIH SBIR Program
The Small Business Innovation Research (SBIR) program is a highly competitive program that encourages domestic small businesses to engage in federal research and development with the potential for commercialization. Through a competitive awards-based program, SBIR enables small businesses to explore their technological potential and provides the incentive to profit from its commercialization.
About Qualia Oto
Qualia Oto is an innovative biomedical device company focused on improving the individual’s quality of life through better aural technologies. By integrating our proprietary shape-adaptive polymers, we are advancing the next generation of cochlear implants allowing for minimal trauma, a superior positioning of electrodes, and an increased effectiveness and stimulatory resolution for chronic, targeted microstimulation. Qualia Oto’s team of medical and scientific experts aim to reshape cochlear implants and their capacity in overcoming debilitating hearing loss.
Source: Qualia Oto
