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NCT06343571 Clinical Trial

Longitudinal Outcomes in MED-EL Cochlear Implant Recipients Using a FLEX Electrode

Cochlear Implants Clinical Trial

— LOTOS  

Official title:
Longitudinal Outcomes in MED-EL Cochlear Implant Recipients Using a FLEX Electrode Array: a Retrospective Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT06343571
Other study ID # MED-EL_CRD_2022_12
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date April 17, 2024
Est. completion date August 2024

Study information
Verified date June 2024
Source MED-EL Elektromedizinische Geräte GesmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This retrospective study aims at analysing data from clinical routine as anonymized data sets. The study aims at analysing clinical data from MED-EL Cochlear Implant (CI) recipients using a FLEX electrode array.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 2000
Est. completion date August 2024
Est. primary completion date August 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - MED-EL CI recipients - FLEX electrode array Exclusion Criteria: - Lack of compliance with any inclusion criterion

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Hannover Medical School Hanover

Sponsors (1)
Lead Sponsor Collaborator
MED-EL Elektromedizinische Geräte GesmbH

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluate short and long term longitudinal clinical performance data from MED-EL CIs to assess their clinical effectiveness and safety. Longitudinal data from clinical routine Through study completion: single data extraction (3 month to completion)
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