Objectives: Limited studies have assessed the long-term effects of middle ear pressure therapy for Meniere’s disease. This study was aimed at evaluating the 12-month outcomes of EFET01® middle ear pressure therapy in patients with Ménière’s disease or delayed endolymphatic hydrops and to analyze the reasons for treatment continuation/discontinuation by patients to obtain evidence for decision-making in clinical practice.
Methods: A total of 24 patients diagnosed as having Ménière’s disease or delayed endolymphatic hydrops who received EFET01® were included in this study. Changes in vertigo symptoms, hearing impairment, and the MRI findings of endolymphatic hydrops (EH) were assessed retrospectively before and after 12 months of treatment. Additionally, we evaluated whether the treatment was continued or discontinued by the patients and documented the reasons behind their decision.
Results: While vertigo symptoms improved significantly following treatment, the hearing level remained unchanged. Despite symptomatic improvement, only 33.3% of the patients chose to continue the treatment due to anxiety about recurrence, as there were no changes on the MRI findings of EH. The relationship between the EH findings on MRI and clinical symptoms could not be clarified.
Conclusion: EFET01® was found to be effective for improving vertigo symptoms at the end of 12 months’ treatment, but had scarce effect on the hearing levels. It is important to inform patients that treatment can be resumed if symptoms recur. Post-treatment EH alone may not be fully predictive of the treatment outcomes. Decisions regarding continuation or discontinuation of EFET01® therapy should be made with caution, taking into account both objective and individual patient preferences.
