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.

Monitoring pressure changes in the inner ear induced by middle ear pressure therapy with an EFET01 device in guinea pigs.

BACKGROUND: As a low-cost, portable, handheld air pressure generation tool not requiring a ventilation tube, the EFET01 device has shown clinical effectiveness for intractable Ménière's disease (MD) patients in Japan. However, no animal studies have investigated changes in inner ear pressure (PI) when applying this device. OBJECTIVE: To determine the PI properties in response to middle ear pressure therapy (MEPT) induced by the EFET01 in guinea pigs. MATERIAL AND METHODS: In seven healthy guinea pigs, bi-phasic pressure pulses from -5 to 12 cm H2O were delivered to the external ear canal and transmitted to the middle and inner ear cavities with an intact tympanic membrane. Hydrostatic pressure change in the inner ear perilymphatic compartment was measured by a servo-controlled micropipette system. RESULTS: From eight successful ears, pressure changes in the middle ear slightly decreased and were instantly transferred to the inner ear. The EFET01 produces a bi-phasic positive/negative pressure pulse, which is approximately twice as large as the monophasic pressure pulse. CONCLUSION: Our study clarified the EFET01's ability to transmit pressure and verified its effectiveness in MD patients as observed in clinical studies. SIGNIFICANCE: The PI properties in guinea pig response to MEPT with the EFET01 device were investigated.