Active not recruitingNAINTERVENTIONAL

Performance and Hearing-related Outcomes in Adults Implanted With the CI622D Dexamethasone-eluting Cochlear Implant Compared to Those Implanted With a Standard Cochlear Implant (CI622)

This study is testing a new cochlear implant, called CI622D. This implant is special because it slowly releases a medicine called dexamethasone, which helps reduce swelling often seen after surgery. We want to find out if this hormone-releasing implant works better for hearing than the standard cochlear implant (CI622), which doesn't have dexamethasone. The study will involve adults who have a type of hearing loss where the inner ear or hearing nerve is damaged. Participants will have their cochlear implant and hearing regularly checked. They will also answer questions about their hearing and how they feel generally. We hope to learn if this new implant offers a better experience and improved hearing for people.

At a glance

Status

Active not recruiting

Phase

Sponsor

Cochlear

Enrolment target

Start

17 Jun 2024

Estimated completion

01 May 2026

Hearing Loss, Bilateral Sensorineural Hearing Loss, Sensorineural Hearing Loss, Bilateral Hearing Loss, Cochlear

What is this study about?

This study is about a new type of 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 bypasses the damaged part of the inner ear and sends sound signals directly to the hearing nerve.

Researchers are testing a new version of this implant, called CI622D. What makes this one different is that it releases a medicine called dexamethasone. Dexamethasone is a type of steroid that can help reduce swelling. After any surgery, including cochlear implant surgery, there can be some inflammation. The idea behind this new implant is that by releasing this medicine directly in the ear, it might help reduce swelling and potentially lead to better hearing results.

The main goal is to see if adults who get the new CI622D implant hear better and have better overall results compared to those who get the standard cochlear implant (CI622) that doesn't release this medicine. By comparing the two, the researchers hope to understand if adding this medicine to the implant makes a positive difference for people with hearing loss.

Key takeaways

Tests a new cochlear implant (CI622D) that releases a swelling-reducing medicine.
Compares the new implant to a standard one (CI622) for adults with inner ear hearing loss.
Aims to see if the medicine-releasing implant improves hearing more.
Participation involves surgery, regular hearing tests, and questionnaires.
You will be randomly assigned to receive either the new or standard implant.
Designed to potentially offer better hearing outcomes by reducing post-surgery swelling.

Who may be eligible?

This study is for adults aged 18 or older who have severe hearing loss in both ears due to inner ear damage (this is called 'sensorineural hearing loss'). You'd be considered if your hearing aids aren't helping enough in the ear that would get the implant.

You would need to be well enough for surgery and willing to follow all the study steps, including being randomly assigned to receive either the new implant or the standard one. You should also be able to understand and speak the language used for the hearing tests, and have had specific vaccinations.

There are also some reasons why you might not be able to join. For example, if you have certain infections in your ear, a specific autoimmune disease, or a history of certain ear conditions or previous ear surgeries in the ear to be implanted. They will also check if you have certain brain conditions or if the structure of your inner ear would make it difficult to place the implant. Your doctor will be able to check all of these specifics.

Quick self-check

Are you 18 years old or older?
Do you have significant hearing loss in both ears from inner ear damage?
Are your current hearing aids not helping enough in the ear that might get the implant?
Are you willing to follow all study instructions and be randomly assigned an implant?
Do you speak the language used for hearing tests?
Do you have a current ear infection or have had certain ear surgeries recently?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you would first need to agree to join after understanding everything about the study. You would then be randomly chosen to receive either the new CI622D implant or the standard CI622 implant. You wouldn't be able to choose which one you get.

After your surgery, you would have regular check-ups where the team will test your implant and your hearing. You'll also be asked to fill out questionnaires about how well you feel you're hearing and your general health. This will help the researchers understand how the implant is working for you and how you're feeling overall. The study will run for a specific period, and you'll have appointments throughout that time to monitor your progress and health.

Potential risks and benefits

Taking part in this study could potentially offer you the benefit of receiving an implant that might lead to better hearing outcomes due to the medicine it releases, though this is what the study aims to find out. As with any surgery, there are general risks, such as infection or bleeding. There might also be unknown effects of the new implant. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (11)

Macquarie University
Sydney, Australia
Royal Prince Alfred Hospital
Sydney, Australia
Westmead Private Hospital
Sydney, Australia
St Vincent Private Hospital
Melbourne, Australia
Royal Victorian Eye and Ear Hospital
Melbourne E., Australia
Centre Hospitalier Universitaire de Lille
Lille, France
Hôpital Universitaire Pitié-Salpêtrière
Paris, France
Centre Hospitalier Universitaire Toulouse
Toulouse, France
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Manchester Royal Infirmary
Manchester, United Kingdom

Common questions

What is a cochlear implant?

It's an electronic device that helps people with severe hearing loss to hear by sending sound signals directly to the brain, bypassing damaged parts of the ear.

What is dexamethasone and why is it in the new implant?

Dexamethasone is a medicine that helps reduce swelling. In this new implant, it's hoped to reduce inflammation after surgery and lead to better hearing results.

Will I get to choose which implant I receive?

No, you will be randomly assigned to either receive the new implant with dexamethasone or the standard implant without it.

Who is this study for?

This study is for adults (18 and over) with significant hearing loss in both ears, where the inner ear or hearing nerve is damaged, and hearing aids don't help enough.

How long will I be in the study?

The study will involve regular check-ups and assessments over a specific period, which the study team will explain in detail.