PMEI Post-Market Clinical Follow-Up

December 11, 2023 updated by: MED-EL Elektromedizinische Geräte GesmbH
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

497

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Sankt Pölten, Austria, 3100
        • Universitätsklinikum St. Pölten, Klinische Abteilung für Hals-Nasen-Ohren
      • Wien, Austria, 1030
        • Wiener Gesundheitsverbund, Klinik Landstraße, Hals-Nasen-Ohren-Allgemeine Ambulanz
      • Wien, Austria, 1090
        • Universitätskliniken der MedUni Wien/AKH Wien, Universitätsklinik für Hals-, Nasen- und Ohrenkrankheiten
    • Oberösterreich
      • Linz, Oberösterreich, Austria, 4020
        • Linz Kepler Universitätsklinikum GmbH, Klinik für Hals-, Nasen- und Ohrenheilkunde
      • Wels, Oberösterreich, Austria, 4600
        • Klinikum Wels-Grieskirchen GmbH, Abteilung für Hals-, Nasen- und Ohrenkrankheiten, Logopädie
  • Germany
      • Erlangen, Germany, 91054
        • Universitätsklinikum Erlangen, Hals-Nasen-Ohren-Klinik, Kopf- und Halschirurgie der Universität Erlangen-Nürnberg
      • Freiburg im Breisgau, Germany, 79106
        • Universitätsklinikum Freiburg, Universitätsklinik für Hals, - Nasen und Ohrenheilkunde Sektionsleitung Experimentell-klinische Otologie
      • Göttingen, Germany, 37075
        • Universitätsmedizin Göttingen, Klinik für Hals-Nasen-Ohrenheilkunde
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover, Klinik für HNO-Krankheiten
      • Lünen, Germany, 44536
        • Zentrum für Mittelohrchirurgie, Belegabteilung für Abteilung Hals-Nasen-Ohrenheilkunde
  • Poland
    • Kajetany
      • Nadarzyn, Kajetany, Poland, 05-830
        • Center of Hearing and Speech Medincus, Clinical Trials Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population included MED-EL PMEI implanted patients with a pre-existing condition which made the implantation of a MED-EL PMEI necessary.

Description

• Inclusion Criteria: Implanted with a MED-EL PMEI; initial implantation or revision implantation receiving a MED-EL PMEI

• Exclusion Criteria: None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1

Total Ossicular Replacement Prostheses:

The primary objective for the total ossicular replacement prostheses was to achieve an ABG ≤ 20 dB by at least 25 % of the patients after the PMEI implantation
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.
2

Partial Ossicular Replacement Prostheses:

The primary objective for the partial ossicular replacement prostheses was to achieve an ABG ≤ 20 dB by at least 53.8 % of the patients after the PMEI implantation.
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.
3

Stapesplasty Prostheses:

The primary objective for the stapes prostheses was to achieve an ABG ≤ 20 dB by at least 86 % of the patients after the PMEI implantation.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ABG
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.
A post-operative minimum and maximum follow-up period was not defined.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse events
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
A post-operative minimum and maximum follow-up period was not defined.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MED-EL Elektromedizinische Geräte GesmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2020

Primary Completion (Actual)

November 2, 2023

Study Completion (Actual)

November 2, 2023

Study Registration Dates

First Submitted

September 29, 2022

First Submitted That Met QC Criteria

September 29, 2022

First Posted (Actual)

October 4, 2022

Study Record Updates

Last Update Posted (Estimated)

December 15, 2023

Last Update Submitted That Met QC Criteria

December 11, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020PMEI001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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