Nonsurgical home treatment of middle ear effusion and associated hearing loss in children. Part II: validation study

Ear, Nose & Throat Journal, Oct, 2005 by Shlomo Silman, Daniel S. Arick, Michele B. Emmer

Abstract

In this prospective follow-up investigation, we examined the efficacy of a modified Politzer device in the home treatment of persistent middle ear effusion (MEE) and associated hearing loss in children who had previously participated in a similar clinical trial. Our study group was made up of 38 patients who had been either (1) untreated control participants in the previous study whose hearing in one or both ears had not returned to normal within 11 weeks of their initial audiologic pretest ("former control group"; n = 30), or (2) active-treatmentparticipants in the previous study whose hearing sensitivity in at least one ear had not improved to within normal limits after treatment and who elected to undergo a continuation of treatment ("extended-treatment group"; n = 8). Treatment efficacy was determined by comparing differences in pre- and posttreatment air-conduction thresholds and otoscopic findings. Following treatment, the former control group experienced significant improvements in hearing sensitivity at all frequencies; at the posttreatment test, hearing sensitivity was within normal limits in 43 of 60 ears (71.7%), and normal or moderate tympanic membrane mobility was observed in 30 of 34 otoscopically examined ears (88.2%). In the extended-treatment group, hearing sensitivity returned to within normal limits in 9 of 10 impaired ears (90.0%). These findings further substantiate the efficacy of our modified Politzer device in improving middle ear function and hearing sensitivity in children with MEE, and they support the reliability of the findings reported in our previous study. These results also indicate that many patients in whom initial treatment is not successful may benefit from extended treatment.

Introduction

We recently reported the results of a randomized controlled clinical trial of a modified Politzer device for the home treatment of persistent middle ear effusion (MEE) and associated hearing loss. (1) Our handheld, battery-operated device emits controlled air pressure and air flow that can be adjusted in accordance with the degree of hearing loss and the patient's age.

In our previous study, we found that twice-daily home treatment over a period of 7 weeks was highly efficacious in restoring hearing in children between the ages of 4 and 11 years who had MEE. At the posttreatment audiologic test, hearing sensitivity had returned to normal in 65 of 88 treated ears (73.9%) and in at least one ear in 40 of 47 treated patients (85.1%); the corresponding figures for the control group were only 23 of 86 (26.7%) and 15 of 47 (31.9%). We also reported that pneumatic otoscopy revealed normal or moderate tympanic membrane mobility in 61 of 65 successfully treated ears (93.8%). (1)

At the conclusion of our previous study, we offered the controls whose heating had not recovered the opportunity to undergo active treatment. We also offered extended treatment to those patients in the active-treatment group who had not completely improved. In this article, we report the findings of our prospective follow-up study.

Patients and methods

Instrumentation. The design and function of our modified Politzer device are described in the report of our previous study. (1) The device emits a controlled air pressure and volume velocity sufficient to effect improvement without discomfort. The device has two settings. Setting number 1 delivers an air pressure of 5.2 psi at a volume velocity of 1,524 ml/min; setting 2 delivers an air pressure of 2.5 psi at a volume velocity of 1,690 ml/min. The device was very similar to one that we had used in two other studies reported in 19992 and 2000. (3)

Patients. Our study population was made up of patients who had furnished informed consent and who satisfied six study criteria: (1) age 4 to 11 years, (2) at least a 2-month history of MEE and associated hearing loss as documented by a physician, (3) pure-tone air-conduction thresholds of 20 dB HL or more at 3 frequencies between 500 and 4,000 Hz with air-bone gaps of 15 dB or more at these frequencies or pure-tone air-conduction thresholds of 25 dB HL or more at 2 frequencies between 500 and 4,000 Hz with air-bone gaps of 15 dB or more at these frequencies at the final pretest, (4) a tympanometric peak pressure of -100 daPa or less at the final pretest, (5) an otologic diagnosis of MEE at the final pretest, and (6) an absence of enlarged adenoids, acute otitis media, and other ear abnormalities at the final pretest otologic examination.

Former control group. At the completion of our previous study, 32 of the 47 controls had not achieved normal hearing in at least one ear. Of these 32 patients, 30 accepted our offer to undergo active treatment.

Extended-treatment group. Eight patients in the active-treatment group of our previous study who had not achieved recovery of heating in one or both ears accepted our offer to continue treatment in the current study.

Procedures. The procedures used in this study were the same as those followed in our previous report, except that we did not include any untreated controls. All patients in this follow-up study received active treatment.