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

Abstract

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.

Chinese Abstract

背景：中耳加压疗法（MEPT）可有效治疗有确诊的梅尼埃病 (MD)的和迟发性内淋巴积水 (DEH)的顽固性眩晕患者, 他们依靠保守治疗难以治愈。一种新颖的无需经鼓室通气管的中耳压力装置, EFET01VR, 由日本开发, 经日本健康劳动福利部批准, 自 2018 年 9 月起在日本国民健康保险中使用。

目的：检查使用 ETET01VR 进行中耳加压疗法的短期治疗效果, 并与之前的临床试验结果相比。

方法：根据日本平衡研究学会 (JSER) 指南而选择的患者在2018 年 9 月至 2021 年 7 月期间使用 EFET01 接受中耳加压疗法 , 44 例患者被纳入在这项回顾性研究中。比较 中耳加压疗法开始后 4 个月分析的临床数据与之前 EFET01 临床试验的结果相同。

结果：使用 EFET01 的 MEPT 显示出与之前临床实验相同的治疗效果, 即改善眩晕的强度和频率而对听力没有影响, 即使在正确使用 MEPT 的 JSER 指南下也是如此。

结论：使用 EFET01 的中耳加压疗法为患有确诊的 MD 和 DEH 的顽固性眩晕患者提供了一种有效的治疗选择。

Keywords:

• Meniere’s disease
• delayed endolymphatic hydrops
• intractable vertigo
• middle ear pressure therapy
• Japanese national health insurance

Disclosure statement

No potential conflict of interest was reported by the authors.

Additional information

Funding

This work is supported by Health and Labor Sciences Research Grant (20FC1048).