Ponto C4.2 Implant : Development of the surgical components of the BAHS system in cooperation with Oticon Medical
Abstract: The purpose of this project has been to evaluate different candidate designs and make design adjustments on the implant in the bone-anchored hearing system (BAHS). This was performed to minimize the surgical procedure and at the same time contain high implant stability. New adjustable abutment concepts have been conceptualized in this project with the reason to create a product more customized for each patient. The work has been carried out by following the Stanford design thinking model. Five stages were involved in the development process: empathize, define, ideate, prototype, and test. The empathize process generated data on existing components, including their advantages and disadvantages. The users have been identified and their requirements defined. Throughout the ideate process, ideas were developed through a variety of innovative methods. The idea phase produced four implant concepts and two abutment concepts, which were then refined in the concept phase. After the concept evaluation stage, the implant concepts were reduced to three, then modeled in 3D, manufactured, and tested. Due to project-related challenges and time constraints, the abutment concept designs were set aside for future development and were not manufactured nor tested. The final product is called the Ponto C4.2 implant. The concept is 1 mm shorter in length and features a unique design, making it the smallest implant currently available for adults with promising ex vivo mechanical performance and stability in comparison with the currently available implants. The design results in decreased osteotomy by minimizing the pre-drilling in the skull bone, which reduces the risks during the implementation procedure and could potentially simplify the installation process.
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