Since their clinical introduction over 30 years ago, cochlear implants (CIs) have had a remarkable impact on patients experiencing moderate-to-profound hearing loss. Recent advances in technology have driven the development of hearing preservation implants and procedures designed to preserve the residual acoustic hearing of patients while treating the damaged areas of the ear with an electrically stimulated CI. Despite these advances, over half of patients undergoing this procedure will eventually lose residual hearing months to years after surgery likely due to cochlear trauma sustained during the surgery. Additionally, because current techniques do not allow the electrode to be inserted farther into the cochlea to reach now dysfunctional regions, patients either require additional surgery or live with suboptimal hearing once again. iotaMotion is developing an implantable robotic-assisted positioning system to enable precise control of intracochlear electrodes both intra- and post-operatively to reduce the effects of post-surgical hearing loss. The anticipated impact of this technology will be to improve the long-term outcomes of patients undergoing hearing preservation cochlear implantation as well as increase the candidacy range for this procedure. The overall goal of this Direct-to-Phase II SBIR project is to further develop and ultimately commercialize iotaMotion's proprietary technology. During Phase I-equivalent SBIR studies, iotaMotion developed and characterized an initial prototype to establish proof of concept and feasibility in cadaveric models. Following that success, Phase II will continue to develop the technology toward commercialization with the following specific aims: 1) Verify device compatibility and open platform with commercially available cochlear implants . Using 3 clinically available electrodes, we will establish the procedure, instructions, and ease of use for integrating each electrode within the device, then determine the maximum stall force that can occur with each device/electrode combination. 2) Establish that the iotaMotion pilot-line system meets functional, quality, safety, and biocompatibility requirements in a GLP environment. Using a combination of international standards and in-house experiments, we will demonstrate that the device can be sterilized, is biocompatible, and can remain functional in the body for up to 6 months. Quality standards will be implemented to ensure valid data are collected for eventual regulatory submission. 3) Evaluate the efficacy of the iotaMotion robotic-assisted surgical system in a long-term large-animal model. Phase II will conclude with an evaluation of the device efficacy in an established sheep model over 3 months. Completing these aims will set the stage for our system development and production in a GMP environment with private-sector partnering and execution of a prospective clinical trial designed to establish safety and efficacy in humans. The phase II project enables iotaMotion to achieve significant commercialization milestones, driving the company forward toward improving the hearing and quality of life for millions worldwide.
Public Health Relevance Statement: Project narrative: Despite the many advances in cochlear implant technology, recent clinical trials have found that up to 56% of patients who undergo hearing preservation cochlear implant surgery experience continued hearing decline after surgery. To address this issue, iotaMotion established the feasibility of developing an implantable robotic-assisted surgical system during Phase I-equivalent SBIR studies using cadaveric models on the benchtop. The iotaMotion team is now proposing a Direct-to-Phase II SBIR project to fully develop the system and test its efficacy in vivo--thereby preparing for regulatory submission, private-sector partnering, and eventual device commercialization to reduce the incidence of residual hearing loss for millions who are candidates for receiving cochlear implants to improve health, productivity, and quality of life.
Project Terms: abstracting; Acoustics; Address; Aging; Animal Model; Animal Testing; Animals; Area; Automobile Driving; base; Biocompatible; Biological Preservation; biomaterial compatibility; Capital; Clinical; Clinical Trials; Clinical Trials Design; Cochlea; Cochlear implant procedure; Cochlear Implants; commercialization; Data; design; Development; Devices; Ear; Electrodes; Ensure; Environment; Evaluation; experience; experimental study; Funding; Goals; Gold; Health; Hearing; hearing impairment; Histology; Housing; Human; Implant; implantation; Implantation procedure; improved; In Vitro; in vivo; Incidence; Individual; Instruction; International; Investments; Letters; Life; man; Manuals; Marketing; meetings; microCT; Modeling; Operative Surgical Procedures; Outcome; Patient-Focused Outcomes; Patients; Phase; Positioning Attribute; Postoperative Period; Private Sector; Procedures; Production; Productivity; Property; prospective; prototype; Quality of life; Recording of previous events; research and development; Residual state; Risk; robot control; Robotics; Safety; seal; Secure; Sheep; Small Business Innovation Research Grant; Staging; Sterilization; success; Surgeon; System; Systems Development; Techniques; Technology; Testing; Trauma; Work
