EMOTO: Development of a novel electromagnetic tracking technology for otology

Abstract: The Cochlear Implant (CI) is the primary treatment modality for patients with severe to profound hearing loss, while continual advances in the preservation of intracochlear structures during implantation make this a viable option for those with residual hearing. Surgical strategies for preserving cochlear function include atraumatic techniques such as slow and consistent insertions, surgical planning, and avoiding intracochlear structures through better understanding of insertion trajectory. However, studies have suggested that trauma to the cochlea during electrode insertion results in damage to delicate inner ear structures, and up to 50% of patients experience delayed hearing loss following surgery resulting in a diminished quality of life.1 In this STTR, iotaMotion aims to develop an electromagnetic tracking system small enough to be integrated into existing hardware and accurate enough to enable trajectory guidance during electrode array insertions. The anticipated impact of this technology will be to improve short and long-term hearing outcomes for CI patients by enhancing structural preservation of the cochlea. The project will develop a working prototype of a new electromagnetic (EM) tracking system (EMOTO) with high accuracy and minimal-footprint integration into iotaMotion’s robotic-assist CI insertion system (iotaSOFT). The project has three Aims: Aim 1: Construct an initial prototype. The first stage of development will include a low-power source driver to power off-the-shelf EM source and sensors attached to the iotaSOFT device. An existing motion calibration system will be modified, and our proprietary algorithms will be scaled appropriately to accommodate the small workspace being used. Finally, we will calibrate the source/sensor combination and test the position and orientation accuracy. Aim 2: Modify iotaMotion device for magnetic compatibility. The current iotaSOFT device will undergo any necessary mechanical redesign to optimize the integration of the EMOTO source and sensor for enhanced performance. Aim 3: Evaluate the EM system integrated into iotaSOFT. The final Aim will evaluate the tracking accuracy of the system in a simulated operating room environment. A calibrated phantom will be used in conjunction with common sources of EM interference to assess the real-world performance of the EMOTO system. Ultimately, the success of Phase I will allow development of this insertion system to progress to a second iteration of the design (based on the knowledge gained in Phase I) and further preclinical testing to establish the efficacy of the device as compared to the current gold standard of EM tracking systems. STTR funding will help secure additional outside investment and bring us closer to commercializing this much needed technology for people suffering from disabling hearing loss.