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Clinical Investigation of the Safety and Performance of HiResTM Ultra Cl HiFocusTM SlimJ Electrode (Cl-1600-05) and HiResTM Ultra 3D Cl HiFocusTM SlimJ Electrode (Cl-1601-05) (Ultra X) in Adults With Severe-to-profound Hearing Loss - Trial NCT04929470

Access comprehensive clinical trial information for NCT04929470 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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NCT04929470
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Trial Details
ClinicalTrials.gov โ€ข NCT04929470
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Clinical Investigation of the Safety and Performance of HiResTM Ultra Cl HiFocusTM SlimJ Electrode (Cl-1600-05) and HiResTM Ultra 3D Cl HiFocusTM SlimJ Electrode (Cl-1601-05) (Ultra X) in Adults With Severe-to-profound Hearing Loss

Study Focus

Cochlear Hearing Loss

cochlear implantation

Observational

device

Sponsor & Location

Advanced Bionics AG

Berlin,Dรผsseldorf, Germany

Timeline & Enrollment

N/A

Jul 06, 2021

Jan 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 SlimJ Electrode and HiResTM Ultra 3D Cl HiFocusTM SlimJ Electrode (Ultra
 X) under normal conditions of use as it is approved for this device. Participants receive
 interventions as part of routine medical care.

ICD-10 Classifications

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

Data Source

ClinicalTrials.gov

NCT04929470

Device Trial