Safety and performance of the new med-el total ossicular replacement prostheses

期刊论文
发表日期：

2024年7月13日

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Esther Schimanski,
Thomas Lenarz,
Susan Busch,
Susan Arndt,
Christian Offergeld,
Christoph Arnoldner,
Dominik Riss,
Joachim Hornung,
Lava Taha,
Paul Martin Zwittag,
Nina Rubicz,
Dirk Beutner,
Nicholas Bevis,
Benjamin Loader,
Franz Windisch,
Georg Sprinzl,
Astrid Magele,
Wendelin Wolfram,
Lisa Niederwanger,
Łukasz Plichta,
Piotr H. Skarżyński

摘要

Purpose

This multicentric, retrospective study provides safety and performance data of the MED-EL total ossicular replacement prostheses (TORP).

Methods

Patients underwent tympanoplasty with mXACT Total Prosthesis Center, mXACT Total Prosthesis Offcenter or mXACT PRO Total Prosthesis. The clinical data were retrospectively analyzed. Follow-up examination included access to the medical record (for adverse events) of the patients, ear microscopy and pure-tone audiometry to determine the post-operative pure tone average of the frequencies 0.5, 1, 2 and 3 kHz (PTA₄). The post-operative PTA₄ air bone gap (ABG) was used to evaluate the audiological outcome. A post-operative minimum and maximum follow-up period was not defined.

Results

103 patients were implanted with a TORP. 102 (88 adults, 14 children; 37 CHL, 64 MHL, 1 not specified) patients were analyzed for safety and 92 (79 adults, 13 children) patients for performance of the prostheses.

Adverse events results (N = 102)

In 1 patient (child, mXACT Total Prosthesis Offcenter) a prosthesis dislocation was reported, which lead to a revision surgery. No prosthesis extrusion or migration was reported.

Audiological results (N = 92)

49 (53.3%) of the 92 patients had a PTA₄ ABG of ≤ 20 dB and therefore a successful rehabilitation. The mean post-operative PTA₄ ABG of all 92 patients was 21.0 ± 9.7 dB. The first endpoint, improvement in post-operative PTA₄ ABG of ≤ 20 dB by ≥ 25% of the patients was achieved. The individual Δ BC PTA₄ (post-operative minus pre-operative BC PTA₄) thresholds were stable (within ± 5 dB HL) in 91 (98.9%) patients. 1 patient had a BC PTA₄ deterioration of 11.3 dB HL.

Conclusion

The MED-EL TORPs are safe and effective for middle ear reconstruction.

Trial registration number NCT05565339, September 09, 2022, retrospectively registered.