CompletedNot Applicable

Safety and Performance of Ultra/Ultra 3D Cl With HiFocus SlimJ Electrode in Adults With Severe-to-profound Hearing Loss

Germany37 participantsStarted 2021-07-06

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * No previous experience with any auditory implant * 18 years of age or older * Postlingual onset of severe hearing loss (≥ 4 years of age) * Limited benefit from appropriately fitted hearing aids, defined as scoring 60% or less in Freiburger Monosyllabic word test * German language proficiency * Willingness to participate in all scheduled procedures outlined in the protocol Exclusion Criteria: * Cochlear malformation or obstruction that would preclude full insertion of electrode array. * Presence of additional disabilities that would prevent or interfere with participation in the required study procedures * Medical or psychological conditions that contraindicate surgery or impact the ability to manage an implanted device or the study related procedures * Evidence of central auditory lesion or compromised auditory nerve * Pregnancy at time of surgery.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Freiburger Monosyllables Score in Quiet

Timeframe: 6 months

Trial details

NCT IDNCT04929470

SponsorAdvanced Bionics AG

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-02-05

Results submitted2026-05-18

View on ClinicalTrials.gov More Cochlear Hearing Loss trials