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| Grant Number: | 5R44DC003613-03 |
| PI Name: | SILMAN, SHLOMO |
| PI Email: | shsilman@aol.com |
| PI Title: | |
| Project Title: | Non-Surgical Device for Treatment of Middle Ear Effusion |
Abstract: 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.
Thesaurus Terms:
audiometry, biomedical equipment development, clinical biomedical equipment, ear /hearing prosthesis, otitis media, portable biomedical equipment
biomedical automation, ear surgery, eustachian tube, exudate /transudate, otoacoustic emission
bioengineering /biomedical engineering
| Institution: | ARISIL INSTRUMENTS, INC. |
| 450 CLINTON ST | |
| NEW YORK, NY 11231 | |
| Fiscal Year: | 2002 |
| Department: | |
| Project Start: | 15-SEP-1998 |
| Project End: | 31-AUG-2003 |
| ICD: | NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS |
| IRG: | ZRG1 |