Objectives: To evaluate the efficacy of a new device, the Meniett, in the treatment of Ménière's disease. The device delivers pressure pulses to the middle ear through a ventilating tube in the tympanic membrane at a frequency of 6 Hz for 0.6 second. After rising to a pressure level of 1.2 kPa, the pressure oscillates between 0.4 and 1.2 kPa. It is believed that the pressure changes are conveyed to the inner ear, inducing a transport of fluids via the pressure outlets and thus reducing the endolymphatic hydrops.
Study Design: A clinical, randomized, multicenter, double-blind, placebo-controlled study. A total of 40 patients were included that had active Ménière's disease according to American Academy of Otolaryngology-Head and Neck Surgery criteria, aged between 20 and 65 years, with a history of at least eight attacks during the past year. After insertion of the ventilation tube, the patients should have had attacks of vertigo for 2 months before entering the study.
Outcome Measures: Primary study endpoints were change in frequency of vertigo, change of functionality profile, and change in patient perception of vertigo (visual analogue scale); secondary endpoints were perception of tinnitus, aural pressure, and hearing, as well as an audiologic evaluation of hearing before and after the treatment period.
Results: The functionality level improved statistically significantly in the active group compared with the placebo group (p = 0.0014), as did the visual analogue scale evaluation of vertigo (p = 0.005). There was a trend toward a reduction of the frequency of vertiginous attacks that was not significant (p = 0.090). With regard to the secondary endpoints, there was no statistical difference between active and placebo groups.
Conclusion: Local overpressure treatment is a novel treatment that is noninvasive, nondestructive, and safe. It significantly reduces vestibular symptoms in patients with Ménière's disease. The Meniett was cleared by the Food and Drug Administration in 2000.