RecruitingNAINTERVENTIONAL

Pediatric Expansion Study of the Sentio System

This study is investigating a special hearing system, called Sentio, for children aged 3 to 11 who have certain types of hearing loss. The Sentio system is already available for people aged 12 and over. This research aims to understand if it's safe and effective for younger children. It will involve 50 children across eight hospitals in Europe. The main goal is to see if the Sentio system helps children hear better in the ear where it's fitted, compared to not using any hearing device. The study will also gather important information about how well it works and if there are any issues for children in this age group.

At a glance

Status

Recruiting

Phase

Sponsor

Oticon Medical

Enrolment target

Start

30 Apr 2025

Estimated completion

01 Jul 2027

Hearing Loss, Conductive Hearing Loss, Mixed Single Sided Deafness

What is this study about?

This study is all about understanding if a listening device, called the Sentio system, is a good option for children aged 3 to 11 years old. The Sentio system is designed to help people who have certain kinds of hearing loss. It's already used safely and effectively by teenagers and adults (12 years and older), but we need to gather specific information about how it works for younger children.

The Sentio system itself involves two main parts: a tiny device that's placed under the skin behind the ear in a small operation, and an external sound processor that clicks onto it. The sound processor picks up sounds from around you, and the implant then gently vibrates the bone, sending these sound messages directly to your inner ear. This bypasses any problems in the outer or middle ear that might be causing hearing difficulties. The main aim of the study is to see if, with the Sentio system, children can hear better in the ear where it's fitted, compared to when they're not using any hearing aid.

This research is a 'prospective study,' which means we're observing participants as they go along. It's taking place in eight hospitals across Europe, including the UK, and plans to involve 50 children in total. The Sentio system was developed by Oticon Medical AB, which is sponsoring this research. The information collected from this study will help ensure that the Sentio system is a safe and helpful option for even more children in the future.

Key takeaways

Tests the Sentio hearing system in children aged 3-11.
Aims to see if it improves hearing and is safe for this age group.
Previously available for ages 12 and above.
Involves a small implant and an external sound processor.
Requires 8 hospital visits over 12 months.
Participation is voluntary, with no impact on future care if you withdraw.

Who may be eligible?

To be considered for this study, children need to be between 3 and 11 years old. They must have certain types of hearing loss that a special type of bone-anchored hearing system would typically help. This might include hearing loss where sound struggles to reach the inner ear (conductive or mixed hearing loss) or if they have very poor hearing in one ear but good hearing in the other (single-sided deafness).

There are also some important conditions. Children should have some previous experience with other hearing aids, like a regular hearing aid or a softband that uses bone conduction. Importantly, they and their parents or guardians must be able and willing to attend all study appointments and follow any instructions from the medical team.

However, some medical conditions could prevent a child from taking part. For example, if there are reasons why surgery or anaesthesia might not be safe, or if there's an active ear infection. Also, if a child has certain skin conditions that might make it hard to use the external sound processor, or if they have an allergy to materials used in the Sentio system, they wouldn't be able to join. The medical team will check all these details carefully to make sure the study is safe and appropriate for everyone involved.

Quick self-check

Is your child aged between 3 and 11 years old?
Does your child have specific types of hearing loss that might benefit from a bone-anchored system?
Does your child have some experience with other hearing aids or devices?
Are you and your child able and willing to attend all study appointments over a year?
Does your child have any ongoing ear infections or allergies to medical silicone?

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

What does participation involve?

If your child takes part in this study, it will involve a total of eight visits to the hospital. The first visit will be before any surgery to check if your child is suitable and to discuss everything. Then there will be the day of the surgery for the implant. After that, there will be six follow-up visits over a year to monitor your child's progress. The very last visit will be 12 months after the initial surgery. During these visits, the medical team will carry out various assessments to see how well the Sentio system is working and to ensure your child is comfortable and safe. There are no specific medications involved in the study beyond what would normally be prescribed after surgery for comfort or healing.

Potential risks and benefits

Participating in this study might offer the potential benefit of improved hearing for your child if the Sentio system is effective for them. This could enhance their ability to communicate and engage with their surroundings. As with any medical procedure, there are potential risks associated with the surgery, such as infection or issues with healing, though these are carefully managed by the medical team. There's also a chance the system might not work as well as hoped. You and your child have the right to withdraw from the study at any time, for any reason, without it affecting their future medical care.

Locations (8)

University Medical Center Groningen
Groningen, Netherlands· Recruiting
Radboud University Medical Center
Nijmegen, Netherlands· Recruiting
Hospital Universitario de Donostia
San Sebastián, Spain· Recruiting
Hospital Universitario Virgen Macarena
Seville, Spain· Recruiting
Hospital Universitario y Politécnico La Fe
Valencia, Spain· Recruiting
Birmingham Children's hospital, Birmingham Women's and Children's NHS Foundation Trust
Birmingham, United Kingdom· Recruiting
The Evelina London Children's Hospital, Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom· Recruiting
Great Ormond Street Hospital, Great Ormond Street Hospital for Children NHS Foundation Trust
London, United Kingdom· Recruiting

Common questions

What is the Sentio system?

It's a special hearing system with a small implant under the skin and an external sound processor that helps send sounds to the inner ear via bone vibrations.

Which children can take part?

Children aged 3 to 11 with specific types of hearing loss, like those affecting sound reaching the inner ear or severe hearing loss in one ear.

What's the main goal of the study?

To check if the Sentio system helps younger children hear better and whether it's safe for them.

How many hospital visits are there?

There are eight visits over a year, including the surgery day and six follow-up appointments.

Can I change my mind about participating?

Yes, participation is completely voluntary, and you can withdraw your child from the study at any time.

How to find out more

Sara Svensson, MSc, PhD

ssve@oticonmedical.com +46 73 504 2041 Official trial record

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