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Short-term safety and effectiveness of the mCLIP partial prosthesis
Thomas Rasse1, Lisa Niederwanger1, Joachim Hornung2
1Department of Otorhinolaryngology, Klinikum Wels-Grieskirchen, 4600, Wels, Austria.
Summary
The mCLIP Partial Prosthesis demonstrated good short-term safety and effectiveness in tympanoplasty patients. Audiological outcomes were satisfactory, with most patients achieving an air bone gap of 20 dB or less.
Area of Science:
- Otolaryngology
- Medical Devices
- Surgical Outcomes
Background:
- Retrospective analysis of mCLIP Partial Prosthesis implantation.
- Clinical trial registration: NCT05565339, registered September 9, 2022.
- Study focused on short-term safety and effectiveness.
Purpose of the Study:
- To evaluate the short-term safety and effectiveness of the mCLIP Partial Prosthesis in tympanoplasty.
- To analyze audiological outcomes and adverse events following prosthesis implantation.
Main Methods:
- Multicentric retrospective study involving patients undergoing tympanoplasty with mCLIP Partial Prosthesis.
- Post-operative assessment included ear microscopy and pure-tone audiometry (PTA4).
- Audiological outcome evaluated by post-operative PTA4 air bone gap (ABG); adverse events (AE) were recorded.
Main Results:
- 72 patients (66 adults, 6 children) received the prosthesis.
- 72.1% of patients achieved a PTA4 ABG ≤ 20 dB; bone conduction thresholds were stable in 67 patients.
- 15 patients (20.8%) experienced adverse events; mean follow-up was 78 days for audiological analysis and 375 days for AE.
Conclusions:
- The mCLIP Partial Prosthesis shows satisfactory audiological parameters post-implantation.
- The prosthesis is deemed safe and effective for both adult and pediatric tympanoplasty patients.
