a AGH-UST University of Science and Technology , Krakow , Poland.
b Faculty of Materials Science and Ceramics, Department of Ceramics and Refractories.
Expert Rev Med Devices. 2019 Apr;16(4):325-331. doi: 10.1080/17434440.2019.1596796. Epub 2019 Mar 26.
Otitis media is one of the most common illnesses which may cause ossicles destruction and conductive hearing loss. However, nowadays the damaged middle ear bones may be replaced by a partial or total ossicular replacement prosthesis. The main aim of this article was to confirm the proper functioning of the new middle ear prosthesis.
This work describes first clinical trials conducted on a group of three patients with the case of interrupted ossicles continuity and chronic otitis media. The clinical trials were performed according to permission No. 157/KBL/OIL2016. The patients were subjected to the bones chain reconstruction via implanting a bactericidal middle ear prosthesis called Otoimplant. The following preoperative and postoperative parameters have been evaluated: Air-Bone-Gap values, mean ABG values in different frequencies, bone and air conductivity, speech audiometry and microbiological assessment. The patients' recovery was observed according to the study protocol on the 7th day and 1, 3, 6 and 12 months after the surgery.
Audiological tests revealed that the mean Air-Bone-Gap was reduced by 36% in all the patients after 1 year. No bacteria or fungi were found in the middle ear spaces.
Results confirm the bactericidal efficacy and hearing improvement of the Otoimplant.
中耳炎是最常见的疾病之一，可能导致听小骨破坏和传导性听力损失。然而，如今受损的中耳听小骨可以通过部分或全部听小骨置换假体来替代。本文的主要目的是确认新型中耳假体的正常功能。
本研究首先对 3 名患有听小骨连续性中断和慢性中耳炎的患者进行了临床试验。临床试验是根据 No. 157/KBL/OIL2016 号许可进行的。患者通过植入一种名为 Otoimplant 的杀菌型中耳假体进行骨链重建。评估了术前和术后的以下参数：气骨导间距值、不同频率的平均气骨导间距值、骨导和气导、言语测听和微生物评估。根据研究方案，在术后第 7 天以及 1、3、6 和 12 个月对患者的恢复情况进行了观察。
听力测试显示，所有患者在术后 1 年内气骨导间距的平均值降低了 36%。中耳腔内未发现细菌或真菌。
结果证实了 Otoimplant 的杀菌效果和听力改善。
