Developing safe tinnitus treatment software

以耳鸣为特征的耳鸣严重影响了大约15万加拿大人的生活质量。尽管在耳鸣治疗上花费了大量资金(美国退伍军人每年在耳鸣残疾索赔上花费超过12亿美元)，但有效的治疗方法却很少。Sound Options已经开发出一种有效的声音治疗方法，科学证明是有效的。然而，要让他们的产品完全提供给患者，需要一个安全的软件实施。为了实现这一点，我们将应用系统的软件工程方法来开发和记录Sound Options的软件，包括以下文件：问题陈述、 开发计划、危害分析、需求说明、验证和确认计划、设计说明、测试报告和用户手册。为了进一步提高可维护性，我们将利用识字编程，其中软件是为人类理解而编写的，而不是计算机理解。为了改善Sound Options的软件开发基础设施，我们将引入现代工具，包括版本控制、自动测试框架和问题跟踪。 这项研究最重要的影响将是使那些患有耳鸣的人能够得到有效的治疗。Sound Options还有一个相关的经济效益，因为开发安全软件的副产品将是美国食品和药物管理局(FDA)相对容易的审批过程。该项目增加了申请人在可认证科学软件和医疗软件开发方面的知识和经验，并有可能加强他与FDA的关系。这些知识和专业知识将传播给学生、同事和加拿大软件行业，从而带来更好、更安全的软件。

Tinnitus, which is characterized by a phantom ringing in the ears, significantly affects the quality of life for an estimated 150,000 Canadians. Despite huge amounts spent on tinnitus treatment (over 1.2 billion is spent annually on tinnitus disability claims by US veterans), few effective treatments are available. Sound Options has developed an effective sound therapy treatment that has been scientifically demonstrated to be effective. However, to make their product fully available to patients requires a safe software implementation. To accomplish this, we will apply a systematic software engineering methodology to the development and documentation of Sound Options's software, including the following documents: problem statement, development plan, hazard analysis, requirements specification, verification and validation plan, design specification, testing report and user manual. To further improve maintainability, we will make use of literate programming, where the software is written for human comprehension, as opposed to computer comprehension. To improve the software development infrastructure of Sound Options, we will bring in modern tools, including version control, an automatic testing framework, and issue tracking. The most significant impact of this research will be enabling effective treatment for those suffering from tinnitus. There is also an associated economic benefit for Sound Options, since a by product of developing the software for safety will be a relatively easy approval process with the US Food and Drug Administration. This project increases the applicant's knowledge and experience of the development of certifiable scientific software and medical software, and potentially strengthens his relationship with the FDA. This knowledge and expertise will be disseminated to students, colleagues, and the Canadian software industry, leading to better and safer software.