一种个性化耳鸣检测治疗仪的研发

Development of a personalized tinnitus detection and treatment instrument

为破解耳鸣临床治疗设备便携性差、检测与治疗分体、个性化精准治疗方案缺乏以及高频耳鸣无疗效等技术瓶颈,该文研究团队基于STM32单片机,采用面向对象的程序设计,通过设计顶层函数、中层函数和底层函数,开拓了具有耳侧选择、耳鸣检测、耳鸣治疗、处方数据存储、设备校准等功能的耳鸣临床检测治疗设备;研发了多种综合切迹和掩蔽的个性化声治疗方案;首创了集耳鸣个性化精准检测和针对性康复治疗于一体的便携式耳鸣检测治疗仪。目前出组的4位耳鸣受试患者显著降低的耳鸣致残量表(tinnitus handicap inventory, THI)得分、耳鸣响度以及失匹配负波(mismatch negative wave, MMN)信号表明:该团队研发的集个性化精准检测和针对性康复治疗功能于一体的便携式设备具有临床有效性,为耳鸣定量客观诊疗标准和处方的建立奠定了应用基础。

[Objective] The treatment of subjective tinnitus is a global problem in hearing clinics. Currently, the technical defects and bottlenecks of tinnitus detection and treatment in hearing clinics include the lack of portable tinnitus detection and treatment equipment that integrates personalized and accurate detection with targeted rehabilitation, lack of precise treatment plans using pleasant music in the background to eliminate patients' discomfort and rejection to secondary hearing damage caused by clinical white noise masking therapy, and lack of effective treatment options for high-frequency tinnitus. This study pioneers the development of a personalized tinnitus detection and treatment instrument.[Methods] In this study, the STM32 embedded single-chip microcomputer is used as the core module to run the software, execute device control and algorithms, control and operate different functional modules, and provide audio decoding conversion module, power conversion module, earphones, and charging interfaces. The audio-decoding chip is designed to realize high-quality stereo multimedia digital signal processing. Staticrandom access memory(SRAM) provides the external memory for the microcontroller unit(MCU). The flash chip stores audio, text, and data. The SD card stores audio files and fonts required by tinnitus detection and treatment equipment, user information, and other large-capacity information. The sound output of this detection and treatment device is transmitted to the patient through the transducer(earphone), and the patient enables human-computer interactions with the device through buttons and screen, all of which form the operation adjustment of tinnitus detection and treatment. Batteries provide power to the whole device. The software adopts object-oriented programming and realizes functions by designing top-level, middle-level, and bottom-level functions. Top-level functions refer to the graphical user interface(GUI) part that targets user programs and functions related to user control. Middle-level functions include each specific page, functions inside the page, and the function of each button operation. Bottom-level functions target the hardware to control and configure peripheral register functions such as memory, screen, audio decoding, keys, SD card, LED, and others. [Results] The proposed tinnitus detection and treatment instrument enabled personalized and precise detection of tinnitus and targeted rehabilitation treatment. Its features included tinnitus ear selection, tinnitus detection, tinnitus treatment, data storage of prescriptions, equipment calibration, and information saving and scanning. It pioneered several comprehensive notching and masking personalized sound treatment solutions and resolved technical defects and bottlenecks of current clinical tinnitus detection and treatment equipment. The treatment results of the first four participants who finished the 8-week treatment using this therapeutic instrument showed a therapeutic effectiveness close to 100%. The tinnitus handicap inventory(THI) score and tinnitus loudness of patients with tinnitus showed a significant downward trend. Significant therapeutic effectiveness was observed among patients with high-frequency tinnitus. Obvious changes to the mismatch negativity occurred in patients with significantly lower THI scores and lower tinnitus loudness. [Conclusions] The proposed portable instrument, not only provides a portable treatment method integrating tinnitus detection and treatment for clinics, its personalized and accurate detection and targeted rehabilitation treatment functions, but also have laid the application foundation for the quantitative and objective diagnoses and treatment standards and prescription establishment.