On the battery life of a totally implantable active middle ear device: a retrospective study in a single implanting center

Abstract

Background

Totally-implantable active middle ear devices (AMED) rely on a non-rechargeable battery encased with the implantable sound processor that needs to be replaced with a minor surgical procedure after its depletion.

Objectives

This study aimed to investigate the most significant factors affecting the implant’s battery life.

Materials and Methods

The implanted subjects (29 patients) were divided into three groups; group A with 17 patients who underwent one battery change surgery; group B with ten patients who underwent two battery changes; and group C with two patients and three surgeries. The battery life was put in correlation with several variables, including daily use and the auditory threshold.

Results

The battery life ranged from 26 to 67 months, with a mean of 48.93 ± 13.47. Pearson’s correlation coefficient revealed that the battery life was statistically correlated only with the mean post-implantation bone conduction thresholds (p-value <.0001).

Conclusions

Although the non-rechargeable battery system of the AMED under study overcomes the drawbacks of daily charging, it needs to be surgically changed after its depletion. The different rates of battery life were shown to mainly depend on the post-implantation BC thresholds, which in some cases showed a deterioration concerning the pre-implanting values.

Chinese Abstract

背景：完全植入式活性中耳装置 (AMED) 依赖于装有植入式声音处理器的不可充电电池。电池耗尽后需要通过小手术更换。

目标：本研究旨在调查影响植入装置电池寿命的最重要因素。

材料和方法：植入受试者（29 名患者）被分为三组； A组有 17 名患者, 接受了一次电池更换手术； B 组有 10 名患者, 接受了两次电池更换手术； C 组有两名患者, 接受了三次手术。 电池寿命与若干个变量相关, 包括日常使用和听觉阈值。

结果：电池寿命为26至67个月, 平均为48.93±13.47。 Pearson 相关系数表明, 电池寿命仅与平均植入后骨传导阈值有统计学相关性（p 值 <.0001）。

结论：虽然所研究的 AMED 不可充电电池系统克服了每天充电的弊端, 但是它在耗尽后需要通过手术更换。 不同的电池寿命比率主要取决于植入后的 BC 阈值, 在某些病例中, 这个阈值显得还不如植入之前。

Keywords:

• Active middle ear device
• totally implantable system
• esteem system
• battery life
• battery change surgery
• audiometry
• bone conduction threshold

Acknowledgments

Not applicable.

Ethical approval

The study was conducted according to the guidelines of the Declaration of Helsinki and approved by the institution review board of Sant Andrea University Hospital, Rome, Italy.

Author contributions

M.B. designed the work, V.M. acquired and analyzed data, L.V. acquired and analyzed data, C.F. acquired and analyzed data, E.C. revised, and approved the manuscript, S.M. revised, and approved the manuscript, H.E. agreed to be accountable for all aspects of the work.

Informed consent statement

Informed consent was obtained from all subjects involved in the study.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Data availability statement

The data presented in this study are available on request from the corresponding author.

Additional information

Funding

The authors have no budget or financial relationships to disclose.