Clinical Used Of Sonotubometry Device CHN-08

Objectives: Sonotubometry, which is wildly used in developed countries, offers a very easy and versatile way objectively to assess the function of Eustachian tube. However, its applications are almost blank in China owing to the high price of the device, and there are no available devices at present. The objectives of this study are to design a low-cost digitalized device for research. This study will improve the performance of the digital sonotubometry device CHN-08, then used to the clinical trial, in order to prepare for the next phase of the experiment.Methods: Based on the CHN-08, we improved the precision of the device, especially the stability of the louder speaker and the sensitivity of the microphone. A total of 69 cases, 136 ears were selected for this study, their symptoms, signs andtest results of tympanometry and CHN-08 testing Eustachian Tube Functions (ETF) were collected. The latency, duration and the increase of the Sound Pressure of Eustachian tube opening were calculate.Results: In 69 patients (136 ears), there are 80 ears showing normal ETF . The control group, 16 ears wihtout symptoms demonstrated mean latency of 24.5±20.1ms, duration of 332.5±178.9 ms, the increase of sound 18.7±6.4dB. Kappa test revealed a midrange concordance between the results of tympanogram and sonotubometry.Conclusion: 1. In clinical studies, sonotubometry device CHN-08 has a good sensitivity and specificity. It has a midrange concordance with the traditional tympanogram test. It is worth to study further with more samples. 2. Sonotubometry device CHN-08 can describe the latency, duration and the increase of the Sound,these parameters are potentially helpful in studying the Eustachian tube.