Non-Surgical Device for Treatment of Middle Ear Effusion

治疗中耳积液的非手术装置

• 批准号: 6523452
• 负责人: SHLOMO NA SILMAN
• 金额: $ 40.63万
• 依托单位: ARISIL INSTRUMENTS, INC.
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-09-15 至 2004-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6523452
• 关键词: audiometry; bioengineering /biomedical engineering; biomedical automation; biomedical equipment development; clinical biomedical equipment; ear /hearing prosthesis; ear surgery; eustachian tube; exudate /transudate; otitis media; otoacoustic emission; portable biomedical equipment

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.

描述（由申请人提供）本研究的目的是测试 便携式、自动化、改良Politzer装置用于非手术治疗的有效性 儿童（4-11岁）中耳积液的管理。的 这项研究的目的是确定平均值的变化是否 从最后的预测试到最后的测试， 后测的结果更大的实验对象接受治疗， 与对照受试者相比。中耳受试者 将积液随机分配至实验组（n=59）和对照组 组（n=59）。每名实验对象将接受每天两次的治疗 （由监护人管理）与便携式，自动化，修改波利策 在7周的时间内，测试后（听力和 耳鼻喉科评估）将在该时期后三周进行 包括在治疗中。这项研究的意义将有 在减少手术治疗需求方面的深远益处 治疗中耳炎从而避免可能的不利影响， 的后续工作，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。 拟议的商业应用： 如果临床试验被证明是成功的，将会引起国家和国际的兴趣。虽然定制的设备成本325美元，包括产品责任，当商业化生产，它将花费约5美元。

项目成果

Nonsurgical Home Treatment of Middle Ear Effusion and Associated Hearing loss in Children. Part II: Validation Study

儿童中耳积液和相关听力损失的非手术家庭治疗。

• 发表时间: 2005
• 期刊: Ear, nose, & throat journal
• 作者: S. Silman;D. Arick;M. Emmer
• 通讯作者: M. Emmer

Nonsurgical home treatment of middle ear effusion and associated hearing loss in children. Part I: clinical trial.

儿童中耳积液和相关听力损失的非手术家庭治疗。

• 发表时间: 2005
• 期刊: Ear, nose, & throat journal.
• 作者: Arick,DanielS;Silman,Shlomo
• 通讯作者: Silman,Shlomo