Short-term audiological outcomes of the mCLIP ARC ball joint prosthesis- a retrospective multicenter study.

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.