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PMCF on Safety and Performance of HiResTM Ultra/Ultra 3D Cl Mid-Scala Electrodes in Adults With Severe-to-profound Hearing Loss - Trial NCT04610112

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.

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Trial Details
ClinicalTrials.gov โ€ข NCT04610112
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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

Study Focus

Cochlear Hearing Loss

cochlear implantation

Observational

device

Sponsor & Location

Advanced Bionics AG

Berlin,Mannheim, Germany

Timeline & Enrollment

N/A

Sep 16, 2020

May 31, 2022

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 loss
Other specified hearing loss
Ototoxic hearing loss
Hearing loss, unspecified
Sudden idiopathic hearing loss

Data Source

ClinicalTrials.gov

NCT04610112

Device Trial