PMEI Post-Market Clinical Follow-Up

MED-EL

Status: Completed

Conditions: Pre-existing Condition

Treatments: Device: PMEIs

Study type: Observational

Funder types: Industry

Identifiers

NCT05565339

2020PMEI001

Details and patient eligibility

About

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

Full 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.

Enrollment: 497 patients

Sex: All

Ages: Under 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

• Exclusion Criteria: None

Trial design

497 participants in 3 patient groups

1

Description:

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

Treatment:

Device: PMEIs

2

Description:

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.

Treatment:

Device: PMEIs

3

Description:

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.

Treatment:

Device: PMEIs