A Compact and Versatile Cochlear Implant Insertion Device for Enhanced and More Accessible Hearing

Research Question Can a robotic insertion preserve natural acoustic hearing during cochlear implant surgery? Background Cochlear implants (CIs) provide a transformative solution for individuals with severe-to-profound sensorineural hearing loss. Despite their potential benefits, only 5-6% of eligible candidates receive CIs due to several barriers. The primary challenge is the risk of intracochlear trauma during electrode array (EA) insertion, which can lead to loss of natural hearing. However, manual surgical insertions cannot reach the accuracy require to avoid intracochlear trauma. This project proposes the development of a robotic insertion system to address these challenges. The system integrates ultra-slow insertion speeds (<0.1 mm/s) and impedance-based sensing to enhance precision, minimise trauma, and expand CI eligibility. Previous cadaveric studies conducted with our device have demonstrated a 47% reduction in insertion force, compared to manual methods, significantly reducing the risk of intracochlear trauma and improving the likelihood of preserving residual hearing. Aims and Objectives The aim of this project is to advance the development and validation of our robotic insertion device to a point that can be used in a clinical safety study with humans. For this we will: 1) involve members of the public; 2) design and manufacture a product that can be used in humans; 3) adapt software to be certified for use in humans; 4) conduct a conduct a pre-clinical study; 4) plan a clinical safety study; 5) ensure commercial viability and economic cost-effectiveness; 6) test and integrate advanced control algorithms to increase procedure safety and effectiveness. Methods The robotic system integrates ultra-slow insertion speeds (<0.1 mm/s) with real-time impedance-based sensing to reduce trauma and improve precision. Pre-clinical validation will include benchtop and cadaveric studies comparing the robotic device with manual techniques. These studies will assess insertion forces, electrode positioning, and cochlear damage. Usability testing with surgeons and patients will ensure safety and ease of use. Health economics analysis will quantify the device potential to reduce complications, surgical time, and recovery time, leading to significant cost savings. Timelines for Delivery We plan to have a final version of our insertion device validated in a pre-clinical trial and ready for a clinical safety study in humans at the end of the 24 months. Impact and Dissemination Our robotic insertion system has the potential to transform CI surgery by preserving natural acoustic hearing, thus expanding eligibility for CIs to millions of patients. Additionally, it offers cost savings by reducing complications, shortening recovery times, and increasing surgical efficiency. Results will be disseminated through scientific publications, conferences, blog posts, and industry partnerships to facilitate regulatory approval and adoption.