This study serves as documentation for the design and creation of a direct-drive hearing aid device intended to sit in the inner ear canal of the individual with a diagnosis of moderate to severe hearing loss. The study was divided into two distinct parts. The first part of the study was focused on the design of the direct hearing device (DHD) and the creation of the prototypes for that device. The second part of the study consisted of a limited clinical trial intended to determine the effectiveness of the device. The results of the study indicate that the new design is feasible for production, it does amplify sound more effectively in comparison to currently available devices on the market, and preliminary findings indicate that the device is comfortable in the completion of common activities associated with use.