Cluster of Excellence Hearing4all, Germany.
Department of Otolaryngology, Hannover Medical School, Hannover, Germany.
Biomed Res Int. 2019 Jan 6;2019:4346325. doi: 10.1155/2019/4346325. eCollection 2019.
OBJECTIVES/HYPOTHESIS: Comparing long term stability of the Middle Ear Transducers (MET) of the 1st generation T1 (Otologics LLC) with the current generation T2 (Cochlear Ltd.) in all our clinical cases with standard incus coupling.
Retrospective chart review.
52 ears implanted with a MET device between 2008 and 2016 were analyzed retrospectively. All patients suffered from sensorineural hearing loss and the actuator was coupled to the body of the incus (standard coupling). 23 ears were implanted with the transducer T1 (Otologics LLC) between 2008 and 2011 and 29 ears were implanted with the current transducer T2 since 2011 (Otologics LLC/Cochlear Ltd.). Latest available in situ and bone conduction (BC) thresholds were exploited for a follow-up period of up to 7 years after first fitting. Long term stability of coupling and actuator performance was evaluated by tracking differences between in situ and BC thresholds.
In the T1 group, 9 out of 23 implants were still used by the patients at their last follow-up visit (average observation time 3.7 yrs.; min 1.0 yrs., max 7.4 yrs.). In 9 patients a technical failure identified by a decrease of in situ threshold of more than 15 dB compared to BC thresholds [Δ (in situ - BC)] lead to non-usage of the implant and 7 explantations. Five other explantations occurred due to medical reasons such as BC threshold decrease, infection, or insufficient speech intelligibility with the device. In the T2 group, 23 out of 29 implants were still used at the most current follow-up visit (average observation time 3.3 yrs.; min 1.0 yrs., max 4.8 yrs.). No technical failures were observed up to more than 4 years after implantation. Five T2 patients discontinued using the device due to insufficient benefit; two of these patients were explanted. One patient had to be explanted before the activation of the device due to disorders of wound healing. Nevertheless, a small but significant decrease of hearing loss corrected coupling efficiency [Δ (in situ - BC)] was seen in the T2 group.
In contrast to the T1 transducers of the earlier generation of MET systems where technical failures occurred frequently, no technical failures were detected after 29 implantations with the current T2 transducers. However, a small but significant decline of transmission efficiency was observable even in the T2 implanted group.
目的/假设：比较第一代 T1（Otologics LLC）与当前一代 T2（Cochlear Ltd.）中耳换能器（MET）在所有标准砧骨耦合的临床病例中的长期稳定性。
回顾性图表审查。
分析了 2008 年至 2016 年间植入 MET 装置的 52 只耳朵的回顾性数据。所有患者均患有感音神经性听力损失，换能器的致动器与砧骨体耦合（标准耦合）。23 只耳朵植入了第一代 T1（Otologics LLC）换能器，2008 年至 2011 年；29 只耳朵自 2011 年以来植入了当前一代 T2（Otologics LLC/Cochlear Ltd.）换能器。利用首次佩戴后长达 7 年的最新原位和骨导（BC）阈值进行随访。通过跟踪原位和 BC 阈值之间的差异，评估耦合和致动器性能的长期稳定性。
在 T1 组中，23 例植入物中有 9 例在最后一次随访时仍被患者使用（平均观察时间 3.7 年；最短 1.0 年，最长 7.4 年）。在 9 例患者中，由于原位阈值与 BC 阈值相比下降超过 15 dB（Δ（原位-BC））而导致技术故障，导致植入物无法使用，并进行了 7 例拆除。另外 5 例拆除是由于 BC 阈值下降、感染或设备语音识别能力不足等医学原因。在 T2 组中，29 例植入物中有 23 例在最近的随访中仍在使用（平均观察时间 3.3 年；最短 1.0 年，最长 4.8 年）。植入后超过 4 年未观察到技术故障。5 例 T2 患者因获益不足而停止使用该设备；其中 2 例患者被拆除。一名患者因伤口愈合障碍而在设备激活前被拆除。然而，在 T2 植入组中观察到听力损失校正耦合效率[Δ（原位-BC）]的小但显著下降。
与第一代 MET 系统的 T1 换能器相比，第一代 T1 换能器经常发生技术故障，而在当前一代 T2 换能器的 29 例植入中未检测到技术故障。然而，即使在 T2 植入组中也观察到传输效率的小但显著下降。
