PMEI Post-Market Clinical Follow-Up

Completed

• Conditions: Pre-existing Condition
• Interventions: Device: PMEIs

• Registration Number: NCT05565339
• Lead Sponsor: MED-EL Elektromedizinische Geräte GesmbH

Brief 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.

Study Timeline

• Study Start: 2020-09-29
• Study First Submitted: 2022-09-29
• Study First Submitted QC: 2022-09-29
• Study First Posted: 2022-10-04
• Primary Completion: 2023-11-02
• Study Completion: 2023-11-02
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-11
• Last Update Posted: 2023-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 497

Inclusion Criteria

Implanted with a MED-EL PMEI; initial implantation or revision implantation receiving a MED-EL PMEI

•

Exclusion Criteria

None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
2	PMEIs	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.
3	PMEIs	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.
1	PMEIs	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

Primary Outcome Measures

Name	Time	Method
ABG	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.

Secondary Outcome Measures

Name	Time	Method
adverse events	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

Trial Locations

Locations (11)

Linz Kepler Universitätsklinikum GmbH, Klinik für Hals-, Nasen- und Ohrenheilkunde; 🇦🇹 Linz, Oberösterreich, Austria

Klinikum Wels-Grieskirchen GmbH, Abteilung für Hals-, Nasen- und Ohrenkrankheiten, Logopädie; 🇦🇹 Wels, Oberösterreich, Austria

Universitätskliniken der MedUni Wien/AKH Wien, Universitätsklinik für Hals-, Nasen- und Ohrenkrankheiten; 🇦🇹 Wien, Austria

Universitätsklinikum St. Pölten, Klinische Abteilung für Hals-Nasen-Ohren; 🇦🇹 Sankt Pölten, Austria

Zentrum für Mittelohrchirurgie, Belegabteilung für Abteilung Hals-Nasen-Ohrenheilkunde; 🇩🇪 Lünen, Germany

Universitätsmedizin Göttingen, Klinik für Hals-Nasen-Ohrenheilkunde; 🇩🇪 Göttingen, Germany

Universitätsklinikum Freiburg, Universitätsklinik für Hals, - Nasen und Ohrenheilkunde Sektionsleitung Experimentell-klinische Otologie; 🇩🇪 Freiburg im Breisgau, Germany

Universitätsklinikum Erlangen, Hals-Nasen-Ohren-Klinik, Kopf- und Halschirurgie der Universität Erlangen-Nürnberg; 🇩🇪 Erlangen, Germany

Medizinische Hochschule Hannover, Klinik für HNO-Krankheiten; 🇩🇪 Hannover, Germany

Center of Hearing and Speech Medincus, Clinical Trials Department; 🇵🇱 Nadarzyn, Kajetany, Poland

Wiener Gesundheitsverbund, Klinik Landstraße, Hals-Nasen-Ohren-Allgemeine Ambulanz; 🇦🇹 Wien, Austria