Objective: 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.
Methods: 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.
Results: 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.
Conclusions: Results confirm the bactericidal efficacy and hearing improvement of the Otoimplant.
Keywords: Polymeric implants; bactericidal; clinical trials; middle ear prosthesis; silver nanoparticles.