Efficiency of a novel middle ear pressure device for intractable definite Meniere’s disease and delayed endolymphatic hydrops after certification by the public health insurance system in Japan

Background: Middle ear pressure therapy (MEPT) is effective in treating intractable vertigo in patients with definite Meniere’s disease (MD) and delayed endolymphatic hydrops (DEH) refractory to conservative treatment. A novel middle ear pressure device, the EFET01^®, which requires no transtympanic ventilation tubes, was developed in Japan, approved by the Japanese Ministry of Health, Labour and Welfare, and has been used under Japanese national health insurance since September 2018. Objectives: To examine short-term therapeutic effect of MEPT using the ETET01^® compared with previous clinical trial results. Methods: Patients selected according to Japan Society for Equilibrium Research (JSER) guidelines underwent MEPT using the EFET01 from September 2018 to July 2021, and 44 patients were enrolled in this retrospective study. Clinical data analysed at 4 months after the start of MEPT were compared with those of the previous clinical trial for the EFET01. Results: MEPT using the EFET01 showed the same therapeutic efficacy as that of the previous clinical trial, i.e. improvement in the intensity and frequency of vertigo with no effect on hearing, even under JSER guidelines for proper use of MEPT. Conclusion: MEPT using the EFET01 provided an effective treatment option for intractable vertigo in patients with definite MD and DEH.