Sterling Medical Devices assisted in the iterative development of support software for a Class II device that addresses the underlying cause of tinnitus. Sterling’s primary development activity was redeveloping the Moderate level of concern software, originally written in Flex. The system components include a handheld acoustic stimuli generator and earphones. The system is customizable to the patient and includes a suite with three types of sounds. The new portal software allows simultaneous access for doctors and patients. The software was developed in two phases. The first phase focused on planning and requirements. In addition to updating the software requirements specification, this phase included an off-the-shelf analysis and system hardware analysis. The hazards were analyzed and mitigation plans were developed. The second phase included the design, implementation, and verification of the software. The software was developed under Sterling’s ISO 13485 and IEC 62304 compliant QMS for later transfer to the client’s QMS.