Objectives: Transtympanic pressure has been shown to influence endolymphatic hydrops. As endolymphatic hydrops plays a key role in Ménière’s disease, a few studies, undertaken by the inventors, manufacturers and associates of the Meniett device,have demonstrated positive short-term effects of transtympanic pressure treatment via the Meniett device in medically intractable Ménière’s disease. The aim of our study was to independently investigate the long-term efficacy and safety of transtympanic pressure treatment in the management of recalcitrant vertigo in Ménière’s disease.
Design: Cross-sectional case study.
Setting: Tertiary referral centre.
Participants: Eighteen patients with Ménière’s disease, suffering from medically intractable symptoms. All patients in the study had Ménière’s
disease according to the criteria of the Committee on Hearing and Equilibrium of the American Academy of Otolaryngology, Head & Neck Surgery.
Main outcome measurements: Outcome and severity of symptoms were assessed, using the six-point functional scale and the vertigo visual analogue scale (VAS), as recommended by the Committee on Hearing and Equilibrium of the American Academy of Otolaryngology, Head & Neck Surgery. Changes of pure tone average thresholds and vestibular calorics before and during treatment with the Meniett device were recorded. The mean follow-up time was 18 months.
Results: Twelve out of 18 patients showed significant improvement in the functional score and in the VAS. Five patients displayed an audiometric improvement, out of which three patients showed a pertaining significant hearing gain of more than 10 dB; the remainder had stable hearing levels. Of six patients without any improvement, four had previous invasive surgery for theirMénière’s disease and two had previous vestibular ablation with gentamicin.No changes in vestibular function were noted. There were no complications duringthe treatment
with the Meniett device.
Conclusion: According to this independent study, the Meniett device seems to be a minimally invasive, non-destructive treatment tool, which can reduce vertigo and associated functional handicap in Ménière’s disease. These effects are maintained up to 18 months after treatment so far. Previous surgical or chemical vestibular ablation procedures may adversely influence the effect of the Meniett device.