Long-term effects of middle ear pressure therapy with the EFET01 device in patients with Ménière’s disease and delayed endolymphatic hydrops in Japan

Background: Long-term efficacy of middle ear pressure therapy (MEPT) with the EFET01 device in patients in Japan with definitive Ménière’s disease (MD) and delayed endolymphatic hydrops (DEH) was evaluated. Objective: To examine the effects of reducing vertigo attacks and improving hearing of MD and DEH patients by using MEPT with the EFET01 device for two years after treatment. Material and Methods: A retrospective study was conducted of 32 MD patients and 2 DEH patients treated by MEPT with the EFET01 device from December 2018 to April 2021. According to Japan Society for Equilibrium Research (JSER) guidelines, patients were investigated for the frequency of vertigo attacks and change in hearing levels during a period of 6 months before to 18–24 months after start of treatment. Results: The frequency of vertigo attacks significantly decreased in both MD and DEH patients, and hearing level has remained stable in the majority of our patients after treatment. Conclusion: Our study clarified that MEPT with the EFET01 device was effective in controlling vertigo symptoms of MD and DEH. It should be considered a safe option for patients failing medical treatment. Significance: The efficacy of MEPT with the EFET01 was shown over a 2-year follow-up period.