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

## TL;DR

This study shows that the mCLIP ARC ball joint prosthesis is safe and effective for improving hearing in the short term.

## Contribution

The study provides new clinical evidence on the short-term safety and audiological outcomes of the mCLIP ARC ball joint prosthesis.

## Key findings

- The mean postoperative air-bone gap was 16.5 ± 9.2 dB, indicating improved hearing.
- 96.4% of cases showed stable bone conduction thresholds.
- Only two adverse events were recorded among 62 patients.

## Abstract

This European multicentric, retrospective study aimed to analyze the short-term safety and effectiveness of the mCLIP ARC Ball Joint Prosthesis.

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.

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.

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.