Non-Surgical Device for Treatment of Middle Ear Effusion

描述(由申请人提供)本研究的目的是测试 便携式自动改良Politzer装置在非手术治疗中的疗效 4~11岁儿童中耳积液的处理这个 这项研究的目的是确定平均水平的变化 气骨间隙和鼓室峰值压力从最终的预试到 接受治疗的实验受试者的后测更大 将该装置与对照组进行比较。中耳受试者 渗出液将被随机分配到试验组(n=59)和对照组 组(n=59)。每个实验对象将接受每天两次的治疗 (由《卫报》管理)配有便携式、自动、改装的Politzer 仪器超过7周的时间。后测试(听力学和 耳鼻喉科评估)将在三周后进行 被治疗所包围。这项研究的意义将具有 减少手术治疗需求方面的深远好处 对于中耳的EfThsion。从而避免了可能的不利影响 后遗症，并大幅降低管理成本 手术治疗2,000美元，非手术治疗约10美元。 建议的商业应用： 如果临床试验被证明是成功的，将会有国家和国际利益。尽管这款定制设备的价格为325美元(含产品责任)，但在商业化生产时，它的成本约为5美元。

DESCRIPTION (provided by applicant) The purpose of this study is to test the efficacy of a portable, automated, modified Politzer device for the nonsurgical management of middle-ear effusion in children (4-11 years of age). The objectives of this study are to determine whether the change in average air-bone gap and tympanometric peak pressure from the final pre-test to the post-test is greater for the experimental subjects who receive treatment with the device as compared with the control subjects. Subjects with middle-ear effusion will be randomly assigned to the experimental (n=59) and control groups (n=59). Each experimental subject will receive twice-daily treatment (administered by the guardian) with a portable, automated, modified Politzer apparatus over a period of 7 weeks. Post-testing (audiologic and otolaryngologic evaluations) will occur three weeks after the period encompassed by the treatment. The significance of this study will have far-reaching benefit in terms of a reduction of the need for surgical treatment for middle-ear efThsion . with resultant avoidance of possible adverse sequellae, and substantial reduction of cost of management from approximately $2,000 for surgical treatment to approximately $10 for nonsurgical management. PROPOSED COMMERCIAL APPLICATIONS: If the clinical trial proves to be successful, there will be national and international interest. Although the custom-made device costs $325 including product liability, when commercially produced, it will cost about $5.00.