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

Abstract

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 (P_I) when applying this device.

Objective

To determine the P_I 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 P_I properties in guinea pig response to MEPT with the EFET01 device were investigated.

Chinese abstract

背景：作为一种低成本、便携式、手持式、无需通风管的气压产生工具, EFET01 装置已经在日本显示出对顽固性梅尼埃病 (MD) 患者的临床有效性。 然而, 尚无动物研究调查当使用这个设备时的内耳压力（PI）。

目标：确定在响应EFET01 引发的豚鼠中耳压力治疗 (MEPT) 时的PI特性。

材料和方法：在七只健康豚鼠中, 双相压力脉冲从 -5 到 12cm H2O被传送到外耳道并通过完整的鼓膜传输到中耳腔和内耳腔。通过服务中心控制的微量移液器系统进行内耳外淋巴室内静水压变化的测量。

结果：在 8 只成功耳中, 中耳的压力变化略有下降, 并且瞬间转移到内耳。EFET01 产生双相正/负压力脉冲, 大约是单相压力脉冲的两倍。

结论：我们的研究阐明了EFET01 传输压力的能力, 并验证了其对MD 患者的有效性,

正如在临床研究中观察到的那样。

意义：研究了在使用 EFET01 装置时, 豚鼠对 MEPT 反应状态下的PI特性。

Keywords:

• EFET01 device
• ménière’s disease
• Middle ear pressure therapy
• inner ear pressure

Acknowledgments

We express our sincere appreciation to Daiichi Medical Co. Ltd. and Mr. Naoki Koike, Mr. Takuro Noguchi for their assistance and cooperation.

Disclosure statement

No potential conflict of interest was reported by the authors.

Additional information

Funding

This work was supported by JST SPRING, Grant Number JPMJSP2145.