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PMEI Post-Market Clinical Follow-Up

NCT05565339 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 497

Last updated 2023-12-15

No results posted yet for this study

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

Conditions

  • Pre-existing Condition

Interventions

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.

Sponsors & Collaborators

  • MED-EL Elektromedizinische Geräte GesmbH

    lead INDUSTRY

Eligibility

Min Age
0 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-29
Primary Completion
2023-11-02
Completion
2023-11-02

Countries

  • Austria
  • Germany
  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05565339 on ClinicalTrials.gov