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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)
See also
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Completed NCT03078920 - Benefits of a Contralateral Routing of Signals (CROS) System in Unilateral CI-recipients N/A
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Completed NCT04721327 - Remote Care: The Future of Cochlear Implants N/A
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Not yet recruiting NCT06375278 - Investigation of a Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation N/A
Not yet recruiting NCT06453343 - Clinical Trial to Compare Two Surgical Approaches to the Cochlea N/A
Completed NCT02748915 - Electrophysiological-based Estimation of Cochlear Implant Fitting N/A
Completed NCT03807830 - Exploring the Use of ECochG Testing During Electrode Insertion in Cochlear Implant Surgery N/A
Completed NCT06322472 - The Relationship Between Phonological Awareness Skills And Home Environment Literacy in Cochlear Implant Users N/A