12-month effect of middle ear pressure therapy with the EFET01 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 for intractable vertigo in patients with definite Meniere’s disease (MD) and treatment-refractory delayed endolymphatic hydrops (DEH). Four-month MEPT with the EFET01^®, an MEPT device developed in Japan and covered by national health insurance since September 2018, has shown efficacy. However, efficacy and safety after 12 months of treatment, which is appropriate for determining the therapeutic effect of MEPT devices, is unclear.

Objectives

Examine the therapeutic effect of 12-month MEPT using the ETET01^®.

Material and Methods

Patients underwent MEPT using the EFET01^® from September 2018 to July 2021. Thirty-three patients followed for >12 months were enrolled in this retrospective study. Clinical data were evaluated in the first and second 6-month treatment periods. Data from the second 6-month period were compared with data from an MEPT study using a different device.

Results

MEPT with the EFET01^® significantly improved vertigo in the first period, with further improvement in the second period. The efficacy and safety were comparable to MEPT with other devices.

Conclusions

MEPT with the EFET01^® is effective for intractable vertigo in patients with definite MD and DEH, and 12-month follow-up is recommended.

Significance

The efficacy of 12-month MEPT with the EFET01^® was demonstrated.

Chinese Abstract

背景：中耳压力疗法（MEPT）对患有确定梅尼埃病 (MD) 和难治性迟发性内淋巴积水 (DEH) 的患者的顽固性眩晕是有效的。EFET01VR是日本研发的MEPT装置, 自 2018 年 9 月以来由国民健康保险cover。使用 EFET01VR 进行四个月的MEPT, 已显示出疗效。然而, 治疗12 个月后的有效性和安全性尚不清楚, 而这才适用于确定 MEPT 装置治疗效果。

目的： 检查使用 ETET01VR 进行12 个月 MEPT 的治疗效果。

材料和方法：2018 年 9 月至 7 月2021期间, 患者接受使用 EFET01VR 的 MEPT治疗。

33 名随访时间超过 12 个月的患者参加了这项回顾性研究。评估第一次和第二次 6 个月治疗期的临床数据。第二次6个月治疗 的数据与使用不同装置的 MEPT 研究数据进行了比较。

结果：在第一期, 使用 ETET01VR 的MEPT 对眩晕有显著改善, 第二期又有进一步改善。疗效和安全性与用其他设备的 MEPT 相当。

结论：使用 ETET01VR 进行MEPT对确诊的 MD 和 DEH患者的顽固性眩晕有效。建议随访 12 个月。

意义：显示了使用 ETET01VR 进行12 个月 MEPT治疗的疗效。

Keywords:

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

Acknowledgments

We express our sincere appreciation to all members of the Department of Otolaryngology, University of Toyama for their assistance and cooperation.

Disclosure statement

The authors have no funding, financial relationships, or conflicts of interest to disclose.

Additional information

Funding

This work was supported by a grant from the Ministry of Health, Labour and Welfare of Japan, Grant Number 20FC1048.