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.
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.
| Arick, Daniel S; Silman, Shlomo (2005) Nonsurgical home treatment of middle ear effusion and associated hearing loss in children. Part I: clinical trial. Ear Nose Throat J 84:567-8, 570-4, 576 passim |
| Silman, Shlomo; Arick, Daniel S; Emmer, Michele B (2005) Nonsurgical home treatment of middle ear effusion and associated hearing loss in children. Part II: Validation study. Ear Nose Throat J 84:646, 648, 650 passim |
