Qualia Oto Secures $300k NIH Phase I Grant to Validate Advantages from Robotic Insertion of Cochlear Implants

Qualia Oto received this Small Business Innovative Research grant from the National Institute of Health - National Institute on Deafness and Other Communications Disorders

Qualia Oto will work alongside Dr. Hongbing Lu at the University of Texas at Dallas as well as iotaMotion, whose iotaSOFT® Insertion System is the only robotic-assisted insertion system commercially available in the United States for cochlear implantation.

April 16, 2025 – The National Institutes of Health announced it will fund Qualia Oto’s Phase I Small Business Innovation Research grant “Robotic-Inserted, Shape-Conforming Cochlear Implant Electrode Arrays.” With this support, Qualia Oto will validate through computational and experimental analyses that its novel shape-changing polymers can be inserted even more reliably and favorably with assistance from robotic machinery. Total funding from the NIH will be more than $304,000 over the coming 12 months.

“The benefits cochlear implants provide are remarkable. However, there is always the risk that something can go wrong during the early stages of implantation,” said Chief Technology Officer Dr. Benjamin Lund. “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.”

There will be two major components explored during this project. First, Qualia Oto will continue to prove the effectiveness of its novel shape-memory polymer (SMP) as a dynamic element that induces controlled self-curling of the CI electrode arrays during cochlear implantation; continual improvements to SMP manufacturing are critical for future commercialization.

Second, Qualia Oto will investigate the value-add of a robotically assisted surgery. New generation machines can be programmed to allow a slow, consistent speed insertion over the course of many minutes – an impossible task for the human hand. Assisting the grant will be the iotaSOFT® Insertion System, manufactured and distributed by iotaMotion, which is the only robotic-assisted insertion system commercially available in the United States for cochlear implantation. Delivering a slow and consistent electrode array insertion down to 0.1 mm/s – which is up to 90% slower than that of a CI surgeon – the technology delivers unprecedented control of the array insertion, which has been shown to reduce trauma to the cochlear when compared to manual insertions.

Senior Research Engineer, Dr. Jimin Maeng (PhD), will lead Qualia Oto’s efforts: "I am excited to receive this award. 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.”

Dr. Hongbing Lu, a professor in the Department of Mechanical Engineering at the University of Texas at Dallas, will oversee the subaward on this grant. Dr. Lu specializes in the mechanics of time-dependent materials, and his research interests include nanoindentation, viscoelasticity, experimental mechanics, and the mechanics of nanostructured materials. His group has invented porous nanostructured materials for drastic acoustic attenuation and applied it for hearing protection, mitigating shock wave, and acceleration reduction under blunt impact for head protection.

“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.”

In 2024, The World Health Organization estimated that 430M people (>5% of the world’s population) had disabling hearing loss, and it projects this will grow to >700M by 2050. According to the National Institute on Deafness and Other Communication Disorders, approximately 15% of American adults reported having difficulty with their hearing. The CI market is continuously growing worldwide due to the increasing aging population, rising prevalence of chronic diseases, growing healthcare awareness, and technological advancements in CIs.

This Phase I SBIR grant will enable Qualia Oto to further develop and validate its novel technologies, provide the opportunity for a Phase II SBIR grant, open the medical space to a new implementation approach, and bring enhanced solutions closer to future clinical use.

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.

For additional information, please contact:

Benedict Voit, Chief Operating Officer

benedict.voit@qualiaoto.com