Active not recruitingOBSERVATIONAL

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

This study is for adults in the UK with severe hearing loss who don't get enough help from their current hearing aids. It's testing a specific new type of cochlear implant called the HiResTM Ultra Cl or Ultra 3D Cl with a HiFocusTM SlimJ Electrode. Researchers want to see how safe this new implant is and how well it helps people hear and understand speech. They will compare hearing ability with the implant to what it was before with hearing aids. Participants will get the implant as part of their usual medical care, and their progress will be followed for six months after the implant is switched on.

At a glance

Status

Active not recruiting

Sponsor

Advanced Bionics AG

Enrolment target

Start

06 Jul 2021

Estimated completion

01 May 2026

Cochlear Hearing Loss

What is this study about?

This study is about a new type of hearing device called a cochlear implant. Cochlear implants are special electronic devices that can help people with severe hearing loss hear sounds and understand speech better when hearing aids are no longer enough. The particular implant being looked at in this study is the 'HiRes Ultra' or 'Ultra 3D' with a 'SlimJ Electrode'. The main goal is to find out if this new implant is safe and if it works well to improve hearing for adults with significant hearing loss.

To do this, the study will compare how well people hear and understand words *before* they get the implant (using their usual hearing aids) with how well they hear *after* they receive the implant and it's been active for six months. The researchers will also carefully record any problems or side effects linked to the implant or the surgery.

Taking part in this study means you would receive one of these implants, and your progress would be closely monitored. This is part of looking at how effective these new devices are in real-world use to help people a bit like you.

Key takeaways

This study tests a new cochlear implant for severe adult hearing loss.
It aims to check safety and how well it improves speech understanding.
Participants will have surgery for the implant in one ear.
Hearing will be assessed before and six months after the implant is active.
Good German language skills are required for the hearing tests.
Participation involves routine care and follow-up for about six months.

Who may be eligible?

To join this study, you need to be at least 18 years old and have severe or profound hearing loss that started after you were four years old. Your current hearing aids shouldn't be helping you enough to understand speech clearly.

You also can't have had any other hearing implants before. You must be able to speak German well, as the hearing tests will be in German, and be willing to attend all study appointments.

You wouldn't be able to join if you have certain medical conditions, difficulties that would stop you from taking part, or if the shape of your inner ear would make the implant difficult to fit. You also can't be pregnant at the time of surgery.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have severe hearing loss that started after age 4?
Do your current hearing aids not help you enough to understand speech?
Have you never had a hearing implant before?
Can you speak and understand German well?
Are you not currently pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a series of hearing tests while using your current hearing aids. These tests help determine if you are a suitable candidate and provide a starting point for comparing your hearing *after* the implant.

Then, you would have an operation to place the cochlear implant in one ear, as part of your normal medical care. After the implant is switched on, your hearing and speech understanding will be checked again about six months later. All along the way, any health issues or problems linked to the implant will be carefully recorded. The total duration of your active participation, once you receive the implant, would be around six months after the device is switched on.

Potential risks and benefits

Participating could offer the potential benefit of improved hearing and speech understanding through a state-of-the-art cochlear implant, especially if your current hearing aids are no longer effective. Like any surgery, there are risks involved with the implant procedure itself, and there's always a small chance of side effects or complications from the device. These will be carefully monitored. You have the right to withdraw from the study at any time without it affecting your medical care.

Locations (3)

HNO-Klinik Düsseldorf
Verified postcode
Düsseldorf, Germany
Unfallkrankenhaus Berlin (UKB)
Verified postcode
Berlin, Germany
Westfälische Wilhelms-Universität Münster
Verified postcode
Münster, Germany

Common questions

What is a cochlear implant?

A cochlear implant is a small electronic device that helps people with severe hearing loss to hear. It's different from a hearing aid because it works inside your ear to send sound signals directly to your brain.

Will I have an operation?

Yes, if you join this study, you will have an operation to place the cochlear implant in one of your ears.

How long will the study follow me?

The study will actively follow your hearing progress for about six months after your cochlear implant is switched on.

Do I have to speak German?

Yes, to be part of this specific study, you need to be able to understand and speak German well, as the hearing tests are designed for German speakers.

What if I change my mind?

You are free to leave the study at any time without explaining why, and this won't affect your medical care.