NCT Number: NCT05565339
Confirm safety and performance of passive middle ear implants (PMEIs) in subjects with pre-existing condition which made the implantation of a MED-EL PMEI necessary
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Notify Me0 year–99 year
All sexes
Observational
Linz Kepler Universitätsklinikum GmbH, Klinik für Hals-, Nasen- und Ohrenheilkunde, Linz, Upper Austria, Austria
Collect retrospective audiological and safety results of PMEI implanted subjects. A post-operative minimum and maximum follow-up period was not defined. The mean of the post-operative follow-up period of all patients was calculated.
Only the study team can determine whether someone qualifies for participation.
To evaluate audiological outcomes post-operatively, the air-bone gap (ABG) was assessed.
To evaluate safety of the devices, adverse events were collected.A post-operative minimum and maximum follow-up period was not defined. The mean of the post-operative follow-up period of all patients was calculated. To assess whether implantation of PMEI affected residual hearing pre- and post-operative bone conduction thresholds were evaluated.
Time frame: A post-operative minimum and maximum follow-up period was not defined.
To collect post-operative PTA4 ABG results. It was expected to achieve a post-operative ABG ≤ 20 dB with a PMEI, by at least 25 % of the total ossicular replacement prostheses patients, by at least 53.8 % of the partial ossicular replacement prostheses patients, and by at least 86 % of the stapes prostheses patients.
Time frame: A post-operative minimum and maximum follow-up period was not defined.
To collect device, surgery or procedure related adverse events and bone conduction thresholds
MED-EL Elektromedizinische Geräte GesmbH
Industry
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