PMEI Post-Market Clinical Follow-Up

MED-EL Elektromedizinische Geräte GesmbH497 enrolled

Overview

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

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

497

Conditions

Pre-existing Condition

Interventions

PMEIsDEVICE

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.

Eligibility

Sex: ALLMin age: 0 YearsMax age: 99 Years

Medical Language ↔ Plain English

• Inclusion Criteria: Implanted with a MED-EL PMEI; initial implantation or revision implantation receiving a MED-EL PMEI • Exclusion Criteria: None

Locations (11)

Linz Kepler Universitätsklinikum GmbH, Klinik für Hals-, Nasen- und Ohrenheilkunde

Linz, Upper Austria, Austria

Klinikum Wels-Grieskirchen GmbH, Abteilung für Hals-, Nasen- und Ohrenkrankheiten, Logopädie

Wels, Upper Austria, Austria

Outcomes

Primary Outcomes

ABG

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.

Secondary Outcomes

adverse events

To collect device, surgery or procedure related adverse events and bone conduction thresholds

Time frame: A post-operative minimum and maximum follow-up period was not defined.

Data from ClinicalTrials.gov

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