Department of Otorhinolaryngology, Head and Neck Surgery, Faculty of Medicine, Academic Assembly, University of Toyama, Toyama, Japan.
Department of Collaborative Research Laboratory of Medical Device Innovation, Faculty of Medicine, University of Toyama, Toyama, Japan.
Acta Otolaryngol. 2023 Oct;143(10):840-844. doi: 10.1080/00016489.2023.2284336. Epub 2024 Jan 5.
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.
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.
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.
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.
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.
The efficacy of MEPT with the EFET01 was shown over a 2-year follow-up period.
评估 EFET01 中耳压力疗法 (MEPT) 对日本确诊梅尼埃病 (MD) 和延迟内淋巴积水 (DEH) 患者的长期疗效。
通过 EFET01 中耳压力疗法治疗后两年，检查 MEPT 对 MD 和 DEH 患者减少眩晕发作和改善听力的效果。
对 2018 年 12 月至 2021 年 4 月接受 EFET01 中耳压力疗法治疗的 32 例 MD 患者和 2 例 DEH 患者进行回顾性研究。根据日本平衡研究学会 (JSER) 指南，在治疗开始前 6 个月至治疗开始后 18-24 个月期间，对患者的眩晕发作频率和听力水平变化进行调查。
MD 和 DEH 患者的眩晕发作频率均显著降低，治疗后多数患者的听力水平保持稳定。
本研究表明，EFET01 中耳压力疗法对 MD 和 DEH 的眩晕症状控制有效。对于药物治疗失败的患者，它应被视为一种安全的选择。
EFET01 中耳压力疗法的疗效在 2 年的随访期内得到了证实。
