User customization and user optimization of cochlear implant devices

描述(由申请人提供)：本申请是R01 DC010494研究基金的三年竞争性修订补充。父母赠款的中心焦点是调查人工耳蜗术中适配参数优化的可能性。这是在使用便携式研究语音处理器的情况下提出的，该处理器允许用户：(A)根据两个结果衡量标准，即质量和清晰度，改变映射图参数；(B)根据不同的收听情况定制映射图，以实现最大效益；以及(C)收集真实声学信号的反馈和录音，以供进一步分析。单侧、双侧和双模式用户将参加双盲现场试验，以评估便携式语音的真正好处 用户可以轻松定制的处理器，以优化他们的收听体验。对于便携式人工耳蜗语音处理器，将使用我们实验室根据NIDCD合同开发的PDA平台。该PDA处理器最近被FDA批准用于IDE临床试验，并分发给8个研究实验室和诊所。假设PDA处理器是 目前在IDE临床试验中，临床监测必须到位，并与母公司R01中建议的研究一起进行。当前竞争性修订应用程序要求对临床监测成本提供支持。还要求提供一名全职工程师的支持，该工程师将负责维护参与诊所的所有与集成开发环境有关的文件，并为掌上电脑处理器上运行的所有软件提供技术支持。这笔补充资金将使PI能够实现原始母公司R01应用程序的目标，并保持符合FDA的规定。 公共卫生相关性：这项工作的结果可以极大地提高大量人工耳蜗使用者的整体生活质量。能够在嘈杂环境中有效沟通的人工耳蜗使用者有更大的机会融入主流教育，提高他们在家庭或工作中的生产力，并为国家的经济增长和竞争力做出更大贡献。

DESCRIPTION (provided by applicant): This application represents a three-year competing revision supplement to research grant R01 DC010494. The central focus of the parent grant was to investigate the potential of optimization of fitting parameters in cochlear implants. This was proposed with the use of a portable research speech processor that allows users to: (a) change MAP parameters based on two outcome measures, namely quality and intelligibility (b) customize the MAP to different listening situations for maximum benefit, and (c) collect feedback and recordings of real acoustic signals for further analysis. Unilateral, bilateral and bimodal users will participate in double-blind field trials to assess the true benefit of a portable speech processor that can be easily customized by the users to optimize their listening experience. For portable cochlear implant speech processor, the PDA platform, which was developed in our lab under an NIDCD contract, will be used. The PDA processor was recently approved by FDA for IDE clinical trials and distributed to 8 research labs and clinics. Given that the PDA processor is currently in IDE clinical trials, clinical monitoring has to be set in place and ongoing with the research studies proposed in the parent R01. Support for the cost of clinical monitoring is requested with the current competing revision application. Support for one full-time engineer who will be responsible for maintaining all IDE-related documentation from the participant clinics and for providing technical support for all software running on the PDA processor is also requested. This supplemental funding will enable the PI to pursue the goals of the original parent R01 application and remain compliant with FDA regulations. PUBLIC HEALTH RELEVANCE: The outcomes of this work can greatly benefit the overall quality of life for a large number of cochlear implant users. Cochlear implant users who are able to communicate effectively in noisy environments have greater opportunity for integration into mainstream education, increase their productivity at home or work and contribute more in the nation's economic growth and competitiveness.