NCT05565339

PMEI Post-Market Clinical Follow-Up

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 497 (actual)
• Sponsor: MED-EL Elektromedizinische Geräte GesmbH · Industry
• Sex: All
• Age: 0 Years – 99 Years
• Healthy volunteers: —

Summary

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

Detailed description

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.

Conditions

• Pre-existing Condition

Interventions

Type	Name	Description
DEVICE	PMEIs	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.

Timeline

• Start date: 2020-09-29
• Primary completion: 2023-11-02
• Completion: 2023-11-02
• First posted: 2022-10-04
• Last updated: 2023-12-15

Locations

11 sites across 3 countries: Austria, Germany, Poland