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

Abstract

In thisprospectivefollow-up investigation, we examinedthe efficacy ofa 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 (I) untreated control participants in the previous study whose hearing in one or both ears had not returned to normal within II weeks of their initial audiolo gic pretest (''former control group "; n = 30), or (2) active-treatment participants 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 frequ encies; at the posttreatment test, hearing sensitivity was within normal limits in 43 of60 ears (71.7%), and normal or moderate tympanic membrane mobility was observed in 30 of34 otoscopically examined ears (88.2%). In the extended-treatment group, hearing sensitivity re

Efficacy of a non-invasive middle ear aeration device in children with recurrent otitis media: A randomized controlled trial protocol

“…The dose is twice-daily, once in the morning and once in the evening. The dose justification is based on previous randomized controlled trials featuring the EP device, which had an excellent safety profile with no longterm sequelae or side-effects [ 5 , 6 ]. This is the dose delivered in 3 previously published randomized controlled trials [ 4 , 5 , 8 ].…”

“…Recent studies suggest a new device, the EarPopper, as a non-invasive treatment for middle ear effusion [ [4] , [5] , [6] ]. The EarPopper is indicated for the treatment of negative middle ear pressure.…”

“…The device is based on the Politzer Maneuver, and works by opening the Eustachian tube by delivering a safe, constant stream of air into the nasal cavity [ 7 , 8 ]. In clinical studies funded by the (Grant#: 5R44DC003613-03), the EarPopper has proven to be effective in reducing chronic middle ear effusions [ [4] , [5] , [6] ].…”

Tympanostomy Tube Care for the Pediatrician

“…According to the manufacturer, the EarPopper delivers a constant stream of air into the nasal cavity, which can open the Eustachian tube during swallow, thereby ventilating the middle ear and drain any effusions. 34,35 The EarDoc is also purported to open up the Eustachian tube but through a sonic vibration that is transmitted through the mastoid bone. Although safe and approved by the Food and Drug Administration, there is a lack of high-quality trials with control or comparison groups, and there are cost issues related to using these therapies.…”

Restoration of middle-ear input in fluid-filled middle ears by controlled introduction of air or a novel air-filled implant

“…To this end, some clinicians and investigators have injected air or gases with lower diffusivity into the effusion-filled MEs of patients (e.g., Koch and Becker, 1981; Andréasson et al, 1983; Silverstein et al, 1993; Silman et al, 2005). These injections produce transitory improvements in hearing that are eventually reduced to the original pathological state.…”