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NCT04610112

PMCF on Safety and Performance of HiResTM Ultra/Ultra 3D Cl Mid-Scala Electrodes in Adults With Severe-to-profound Hearing Loss

Clinical Investigation of the Safety and Performance of HiResTM Ultra Cl HiFocusTM MS Electrode (Cl-1600-04) and HiResTM Ultra 3D Cl HiFocusTM MS Electrode (Cl-1601-04) (Ultra X Implants) in Adults With Severe-to-profound Hearing Loss
Advanced Bionics AG·ClinicalTrials.gov·device·Device trialRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Cochlear Hearing Loss
Drug/Device/Intervention
cochlear implantation
Study type
Observational
Intervention type
device
Sponsor & location
Primary sponsor
Advanced Bionics AG
Location
Berlin,Mannheim, Germany
Timeline & enrollment
Phase
N/A
Start date
Sep 16, 2020
End date
May 31, 2022
Enrollment
30 participants
Primary outcome

Speech recognition score (word score),Analysis of participants with device failure

Summary

This is a prospective study designed to evaluate the safety and performance of the HiResTM
 Ultra Cl HiFocusTM MS Electrode and HiResTM Ultra 3D Cl HiFocusTM MS Electrode (Ultra X)
 under normal conditions of use as it is approved for this device.

ICD-10 classifications
Other hearing lossOther specified hearing lossOtotoxic hearing lossHearing loss, unspecifiedSudden idiopathic hearing loss
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT04610112
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT04610112 through Pure Global AI's free database. This phase not specified trial is sponsored by Advanced Bionics AG and is currently Recruiting. The study focuses on Cochlear Hearing Loss. Target enrollment is 30 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.