Active not recruitingNAINTERVENTIONAL

A Pivotal Study to Evaluate the Efficacy and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults

This study is looking at a new type of hearing device called a totally implantable cochlear implant (TICI) system. Unlike current hearing aids or some cochlear implants, this system would be completely hidden under the skin, so you wouldn't need a part on the outside of your ear. It's designed to pick up sounds and speech from the environment, helping people with severe hearing loss hear more clearly. We want to see how well it works and if it's safe for adults who have a specific kind of hearing loss (sensorineural). Participants will have their hearing checked and fill out questionnaires to share their experiences.

At a glance

Status

Active not recruiting

Phase

Sponsor

Cochlear

Enrolment target

Start

01 Dec 2025

Estimated completion

01 Oct 2027

Hearing Loss, Bilateral Sensorineural

What is this study about?

This study is a really important step in developing new ways to help people with hearing loss. It's looking at a device called a totally implantable cochlear implant, or TICI for short. Imagine a hearing device that works completely from under your skin – that's what this study is exploring. The idea is to have a small microphone under your skin that can pick up sounds and send them to the implant, helping you to hear without needing to wear a visible device on the outside of your ear.

This device is for adults who have what's called sensorineural hearing loss. This type of hearing loss happens when there's damage to the inner ear or the nerve that carries sound signals to your brain. For people with this kind of hearing loss, standard hearing aids might not be enough. This new implant aims to offer a different solution, potentially making it easier and more discreet for people to hear in their daily lives.

By taking part, individuals will help researchers understand how well this new implant works, how safe it is, and how it impacts people's ability to hear and their overall quality of life. The information gathered will be crucial in deciding if this technology could be widely available in the future to help many more people with hearing difficulties.

Key takeaways

New fully implantable hearing device being tested.
Aims to help adults with severe sensorineural hearing loss.
Could allow for hearing without external parts.
Participation involves surgery and follow-up appointments.
You must be 18+ and meet specific hearing loss criteria.
Your well-being is a priority, and you can withdraw anytime.

Who may be eligible?

To join this study, you need to be at least 18 years old. You must have severe hearing loss in one ear that would normally make you a candidate for a cochlear implant, and your current hearing aid in that ear isn't helping enough. You should be willing to have the implant placed in only one ear and be able to speak the language used in the study.

There are also some reasons why you might not be able to join. For example, if you've already had a cochlear implant in either ear, or if you have certain types of infections in your ear or have recently had ear surgery. If your hearing loss started very early in life (before age 5) and was very severe, or if you've had severe hearing loss for more than 20 years, you might not be eligible. We also need to make sure there are no other medical conditions that would make the surgery or the implant unsafe for you.

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 in one ear that typical hearing aids don't help much?
Are you willing to have surgery for an implant in one ear?
Have you NOT had a cochlear implant before in either ear?
Do you have access to a compatible smartphone?
Do you not have certain ear infections or recent ear surgeries?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first go through some checks to make sure the study is right for you. If you qualify, you'll have surgery to place the implant. After the surgery, there will be several follow-up appointments where doctors will check how you're healing, activate and adjust your implant, and test your hearing. You'll also be asked to complete questionnaires about your hearing and general well-being. The total duration of your participation, including all visits and assessments, will be explained to you before you agree to join.

Potential risks and benefits

Taking part in this study could offer the potential benefit of improved hearing through a completely internal device, which might mean a better quality of life and less noticeable hearing support. However, like any surgery, there are potential risks, such as infection, pain, or issues with the implant itself. You'll be fully informed about these risks before you agree to participate. Remember, your participation is completely voluntary, and you can withdraw from the study at any time without affecting your medical care.

Locations (8)

Royal Prince Alfred Hospital
Verified postcode
Camperdown, Australia
Macquarie University Hospital
Approximate
Macquarie, Australia
Westmead Private Hospital
Verified postcode
Westmead, Australia
Westmead Public Hospital
Verified postcode
Westmead, Australia
Royal Victoria Eye and Ear Hospital
Verified postcode
East Melbourne, Australia
St Vincent's Private Hospital
Verified postcode
East Melbourne, Australia
Centre Hospitalier Universitaire Grenoble Alpes
Verified postcode
La Tronche, France
Centre Hospitalier Universitaire de Lille
Verified postcode
Lille, France

Common questions

What is a totally implantable cochlear implant?

It's a new hearing device designed to be completely placed under your skin, helping you hear without needing any external parts.

Who is this study for?

This study is for adults (18 years and older) with severe sensorineural hearing loss in one ear, where hearing aids aren't helping enough.

Will I need surgery if I join?

Yes, if you're eligible and choose to participate, you will have surgery to place the new implant.

What kind of hearing loss is this implant for?

It's for sensorineural hearing loss, which is when there's damage to the inner ear or the nerve that sends sound to the brain.

Can I still use my hearing aid in the other ear?

The study focuses on the implanted ear, but specific guidance on other hearing aids will be discussed by the medical team.