Eur Arch Otorhinolaryngol. 2025 May 29. doi: 10.1007/s00405-025-09475-w. Online ahead of print.
ABSTRACT
PURPOSE: This European multicentric, retrospective study aimed to analyze the short-term safety and effectiveness of the mCLIP ARC Ball Joint Prosthesis.
METHODS: Type III Tympanoplasty with implantation of a mCLIP-ARC Partial Prosthesis was performed. During patients' follow-up, ear microscopic evaluation and pure-tone audiometry were used for analysis. The post-operative pure-tone average of the frequencies 0.5, 1, 2 and 3 kHz (PTA4) were used for calculation of the air bone gap (ABG). Adverse events (AE) were evaluated during follow-up.
RESULTS: 62 patients underwent implantation of the mCLIP-ARC Partial Prosthesis. 55 complete data sets were available for audiological examination. The mean follow-up time was 58 days. In two cases adverse events were recorded. The post-operative bone conduction (BC) PTA4 thresholds were stable in 96.4% of cases. The mean postoperative PTA-4 air-bone gap (ABG) was 16.5 ± 9.2 dB.
CONCLUSION: Implantation of the mCLIP ARC partial prosthesis proves to be safe and reliable. Clinical data show satisfactory audiological results and demonstrate the effectiveness of the new middle ear prosthesis with a balanced ball joint.
PMID:40439925 | DOI:10.1007/s00405-025-09475-w