Clinical outcomes of 188 patients implanted with Med-El stapes prostheses.

PURPOSE: This multicentric, retrospective study aimed to analyze the safety and effectiveness of the mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis, and mFIX Stapes Prosthesis.

METHODS

Patients underwent stapes surgery and implantation of a mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis, or mFIX Stapes Prosthesis (MED-EL, Innsbruck, Austria). The clinical data was retrospectively analyzed. Follow-up examination included access to medical records (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 PTA4 ABG ≤ 20 dB was defined as successful rehabilitation. A post-operative minimum and maximum follow-up period was not defined.

RESULTS

189 patients were implanted with a MED-EL stapes prosthesis mainly as treatment of hearing loss caused by otosclerosis. 188 (186 adults, 2 children; 57 conductive hearing loss (CHL), 131 mixed hearing loss (MHL)) patients were examined for adverse events (AEs). 168 (166 adults, 2 children, 51 CHL, 117 MHL) patients underwent audiological examination. Audiology: 110 (65.5%) patients achieved a post-operative PTA4 ABG ≤ 10 dB. 154 (91.7%) patients achieved a post-operative PTA4 ABG ≤ 20 dB and therefore successful rehabilitation. Individual bone conduction (BC) PTA4 thresholds were stable in 159 (94.6%) patients. AEs: 12 (6.4%, adults only) patients had 13 AEs.

CONCLUSION

Clinical data demonstrated satisfactory audiological results after implantation of the mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis, and mFIX Stapes Prosthesis. The MED-EL stapes prostheses are safe and effective.

TRIAL REGISTRATION NUMBER: NCT05565339 (clinicaltrials.gov).