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

Eur Arch Otorhinolaryngol. 2024 Nov;281(11):5687-5697. doi: 10.1007/s00405-024-08784-w. Epub 2024 Jul 13.

Abstract

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.

Keywords: Hearing restoration; Total ossicular replacement prostheses; Tympanoplasty type 3; mXACT PRO Total Prosthesis; mXACT Total Prosthesis Center; mXACT Total Prosthesis Offcenter.

Publication types

  • Multicenter Study

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Audiometry, Pure-Tone*
  • Child
  • Child, Preschool
  • Female
  • Humans
  • Male
  • Middle Aged
  • Ossicular Prosthesis*
  • Ossicular Replacement* / methods
  • Postoperative Complications / epidemiology
  • Prosthesis Design
  • Retrospective Studies
  • Treatment Outcome
  • Tympanoplasty* / methods
  • Young Adult

Associated data

  • ClinicalTrials.gov/NCT05565339