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Nasal sound pressure as objective verification of implant in active transcutaneous bone conduction devices

机译:鼻声压作为主动式经皮骨传导装置中植入物的客观验证

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摘要

>Objective: Active transcutaneous bone conduction devices consist of an external audio processor and an internal implant under intact skin. During the surgical procedure, it is important to verify the functionality of the implant before the surgical wound is closed. In a clinical study with the new bone conduction implant (BCI), the functionality of the implant was tested with an electric transmission test, where the output was the nasal sound pressure (NSP) recorded in the ipsilateral nostril. The same measurement was performed in all follow-up visits to monitor the implant's functionality and transmission to bone over time. The objective of this study was to investigate the validity of the NSP method as a tool to objectively verify the implant's performance intraoperatively, as well as to follow-up the implant's performance over time.>Design: Thirteen patients with the BCI were included, and the NSP measurement was part of the clinical study protocol. The implant was electrically stimulated with an amplitude-modulated signal generator using a swept sine 0.1–10 kHz. The NSP was measured with a probe tube microphone in the ipsilateral nostril.>Results: The NSP during surgery was above the noise floor for most patients within the frequency interval 0.4–5 kHz, showing NSP values for expected normal transmission of a functioning implant. Inter-subject comparison showed large variability, but follow-up results showed only minor variability within each subject. Further investigation showed that the NSP was stable over time.>Conclusion: The NSP method is considered applicable to verify the implant's functionality during and after surgery. Such a method is important for implantable devices, but should be simplified and clinically adapted. Large variations between subjects were found, as well as smaller variability in intra-subject comparisons. As the NSP was found to not change significantly over time, stable transmission to bone, and implant functionality, were indicated.
机译:>目标:主动式经皮骨传导设备由外部音频处理器和完整皮肤下的内部植入物组成。在外科手术过程中,重要的是在闭合外科伤口之前验证植入物的功能。在使用新的骨传导植入物(BCI)进行的临床研究中,通过电传输测试对植入物的功能进行了测试,其中输出为同侧鼻孔中记录的鼻声压(NSP)。在所有后续随访中均进行了相同的测量,以监测植入物的功能以及随时间推移向骨骼的传播情况。这项研究的目的是调查NSP方法作为客观地验证手术中植入物性能的工具的有效性,以及随时间推移随访植入物性能的方法。>设计:包括BCI,NSP测量是临床研究方案的一部分。植入物通过振幅调制信号发生器(扫描后的正弦波为0.1–10 kHz)进行电刺激。 NSP用同侧鼻孔中的探管麦克风测量。>结果:大多数患者在0.4-5 kHz频率间隔内,手术期间NSP高于本底噪声,显示了预期正常的NSP值功能植入物的传输。受试者之间的比较显示出较大的变异性,但随访结果显示每个受试者内的变异性很小。进一步的研究表明NSP随时间推移是稳定的。>结论: NSP方法被认为可用于验证手术期间和之后的植入物功能。这种方法对可植入设备很重要,但应简化并在临床上进行调整。发现受试者之间的差异较大,而受试者内部比较的差异较小。由于发现NSP不会随时间发生显着变化,因此表明了向骨骼的稳定传输以及植入物的功能。

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