RecruitingNAINTERVENTIONAL

Dexamethasone Eluting Cochlear Implant: a Pivotal Study

This study is looking at a new cochlear implant called CIDEXEL. It's special because it slowly releases a medicine called dexamethasone, which is an anti-inflammatory, into the ear after surgery. The hope is that this medicine will help reduce swelling and improve how well the implant works over time. We want to find out if this new implant is safe and if it helps people hear and understand speech better than existing implants. We'll be comparing people's hearing before and after getting the implant. This study is for adults aged 18 to 85 who have significant hearing loss and meet specific medical requirements for a cochlear implant.

At a glance

Status

Recruiting

Phase

Sponsor

MED-EL Elektromedizinische Geräte GesmbH

Enrolment target

Start

02 Sep 2024

Estimated completion

30 May 2026

Cochlear Implant

What is this study about?

Imagine getting a new hearing device, a cochlear implant, that not only helps you hear but also has a built-in helper for healing. That's exactly what this study is about! We're exploring a new type of cochlear implant called CIDEXEL. It's designed to gently release a medicine called dexamethasone, which is really good at calming down inflammation (swelling) and helping the body recover. When a cochlear implant is put in, it's a bit like introducing a new guest to your inner ear, and sometimes the body reacts with a bit of swelling. This medicine aims to make that process smoother.

The main goal of this study is to see if this new implant is safe and if it helps people understand speech better after they've had their surgery. We'll be looking at how well people hear and understand words before the implant and then again around six months after the operation. We hope to see a real improvement in their ability to understand speech. We'll also be checking other things like how the implant is working inside the ear and how it affects people's overall quality of life.

This is a really important step in making cochlear implants even better. By potentially reducing any irritation after surgery, we hope to improve the long-term success and comfort for people who rely on these devices to hear. The study will carefully check everything to make sure the implant is both effective and safe for future use.

Key takeaways

This study is testing a new cochlear implant that releases medicine to aid healing.
It aims to improve speech understanding for people with significant hearing loss.
The study includes adults aged 18-85 who are suitable for a cochlear implant.
Participation involves surgery and follow-up visits over approximately six months.
The goal is to confirm the new implant is safe and effective.
You have the right to leave the study at any time.

Who may be eligible?

This study is looking for adults who are at least 18 years old and up to 85 years old. To join, you need to have hearing loss in one ear that is severe enough for a cochlear implant. You should have already tried hearing aids for at least three months and found them not to be enough. Importantly, your inner ear (cochlea) needs to be suitable for the implant, and your general health should be good enough for surgery and participating in the study.

You won't be able to join if you've already had a cochlear implant in the ear we're looking at, or if there are any problems with the structure of your inner ear that would make surgery difficult or risky. If you're allergic to any of the materials in the implant or have an active ear infection, you also won't be able to take part. The doctors will do checks to make sure your ear's anatomy is right and that your hearing nerve is working.

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 to 85 years old?
Do you have significant hearing loss in one ear, despite trying hearing aids?
Is your inner ear suitable for a cochlear implant?
Are you generally healthy enough for surgery?
Have you not had a cochlear implant in the ear being considered for this study?
Do you have no known allergies to the implant materials?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have several appointments. Before the surgery, you'll have tests to check your hearing and overall health. You'll then have the cochlear implant surgery. After the surgery, there will be follow-up visits over six months. These visits will involve more hearing tests, checking how well the implant is working, and answering questionnaires about your quality of life and how you're doing with your hearing. The total duration of your participation in the study from the first tests to the last follow-up will be around six months.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving a new type of cochlear implant that could lead to better healing and speech understanding. However, as with any surgery, there are potential risks, including those associated with anaesthesia and the surgery itself, as well as the chance that the new implant may not work as expected. You will be fully informed of all known risks before deciding to participate. Remember, your participation is voluntary, and you have the right to withdraw from the study at any time without affecting your medical care.

Locations (7)

HNO-Klinik der Ruhr-Universität Bochum
Verified postcode
Bochum, Germany· Recruiting
Klinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde
Verified postcode
Dresden, Germany· Recruiting
Universitätsklinikum Frankfurt Klinik für HNO-Heilkunde
Verified postcode
Frankfurt, Germany· Recruiting
Martin-Luther-Universität Halle-Wittenberg, Universitätsklinik und Poliklinik für Hals-Nasen-OhrenHeilkunde, Kopf- und Hals-Chirurgie
Verified postcode
Halle, Germany· Recruiting
HNO-Klinik der Medizinischen Hochschule Hannover
Verified postcode
Hanover, Germany· Recruiting
Universitätsklinik für Hals-, Nasen- und Ohrenheilkunde
Verified postcode
Tübingen, Germany· Recruiting
Klinik und Poliklinik für Hals-, Nasen- und Ohrenkrankheiten, plastische und ästhetische Operationen. Die Universitäts-HNO-Klinik Würzburg
Verified postcode
Würzburg, Germany· Recruiting

Common questions

What is a cochlear implant?

A cochlear implant is a small electronic device that helps people who are severely hard of hearing or deaf to hear. It's different from a hearing aid because it works by sending sound signals directly to the hearing nerve.

What is dexamethasone?

Dexamethasone is a type of medicine known as a steroid. It's often used to reduce swelling and inflammation in the body, which can help with healing.

Will I know if I'm getting the new implant or a standard one?

Everyone in this study will receive the new CIDEXEL implant, which includes the dexamethasone medicine. There isn't a comparison group receiving a standard implant without the medicine.

What is 'speech intelligibility'?

Speech intelligibility means how well you can understand spoken words. The study will test how clearly you can hear and understand speech before and after getting the implant.

How long will the study last for me?

If you join the study, you'll be involved for about six months in total, from your initial checks to your final follow-up appointment after the surgery.

How to find out more

Stefano Morettini, PhD

stefano.morettini@medel.com +43664607051034 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.