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Polymeric middle ear prosthesis enriched with silver nanoparticles - first clinical results
Magdalena Ziąbka1, Katarzyna Malec2
1a AGH-UST University of Science and Technology , Krakow , Poland.
This study shows the new Otoimplant prosthesis effectively improves hearing and reduces the air-bone gap by 36% in patients with chronic otitis media. The implant also demonstrated bactericidal efficacy, preventing middle ear infections.
Area of Science:
- Otolaryngology
- Biomedical Engineering
- Regenerative Medicine
Background:
- Otitis media frequently leads to ossicular destruction and conductive hearing loss.
- Middle ear prostheses offer a solution for reconstructing damaged ossicles.
- The Otoimplant is a novel bactericidal prosthesis for ossicular reconstruction.
Purpose of the Study:
- To evaluate the clinical performance and efficacy of the Otoimplant prosthesis.
- To assess hearing improvement and bactericidal properties of the new middle ear prosthesis.
Main Methods:
- Clinical trials involving three patients with chronic otitis media and interrupted ossicles.
- Reconstruction of the ossicular chain using the Otoimplant prosthesis.
- Preoperative and postoperative evaluation of audiological parameters (Air-Bone-Gap, speech audiometry) and microbiological assessment.
Main Results:
- A 36% reduction in the mean Air-Bone-Gap was observed across all patients after one year.
- No bacterial or fungal presence was detected in the middle ear post-implantation.
- Successful hearing improvement and functional recovery were noted.
Conclusions:
- The Otoimplant prosthesis demonstrates significant hearing improvement in patients with ossicular defects.
- The bactericidal properties of the Otoimplant contribute to a safe and infection-free middle ear environment.
- The study confirms the efficacy of the Otoimplant for ossicular reconstruction.
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