All studies
RecruitingNot ApplicableInterventional

Safety and performance of the Nurotron CS-30A cochlear implant system in adults with hearing loss

Many adults live with severe hearing loss that cannot be helped by standard hearing aids. A cochlear implant is an electronic device fitted during surgery that bypasses damaged parts of the inner ear to directly stimulate the hearing nerve. This clinical study is testing the Nurotron CS-30A cochlear implant system in adults across the UK and Europe. Doctors want to see how safe the implant is and how much it improves everyday hearing and quality of life. To be eligible, you must be 18 or older, have severe hearing loss in both ears that started after you learned to talk, and get little benefit from hearing aids. Everyone who takes part receives the implant from a specialist surgical team. You will have regular hearing checks and fill in questionnaires over a 12-month period to monitor your progress.

At a glance

Status
Recruiting
Phase
Not Applicable
Sponsor
Nurotron Global SARL
Enrolment target
40
Start
12 May 2026
Estimated completion
15 Nov 2026

What is this study about?

Hearing loss can make conversations, work, and social life very difficult. While standard hearing aids help many people by making sounds louder, they rely on working parts of the inner ear. When hearing loss is severe or profound, sounds can become too distorted for hearing aids to work well. In these cases, a cochlear implant can often help.

A cochlear implant has an external sound processor that sits behind the ear and an internal part placed under the skin during a surgical procedure. It picks up sound, turns it into electrical signals, and sends them straight to the hearing nerve. This study is testing a specific model called the Nurotron CS-30A cochlear implant system.

The main goal of this research is to check how safe this system is and how well it helps adults hear in everyday situations. Specialist ear clinics in the UK, Germany, Spain, and Poland are taking part. The results will give doctors valuable information on how this device performs in standard clinical care.

By taking part, participants help researchers understand whether this system can provide clear speech perception, improve confidence, and boost general quality of life for adults living with severe hearing loss.

Key takeaways

  • Tests the safety and performance of the Nurotron CS-30A cochlear implant system.
  • Aimed at adults with severe hearing loss who get limited help from standard hearing aids.
  • Every participant receives the cochlear implant surgery from specialist surgeons.
  • Involves regular hearing assessments and check-ups over a 12-month period.
  • Participation is voluntary, and you can leave the study at any time.

Who may be eligible?

You may be able to join this study if you are 18 years of age or older and have severe-to-profound hearing loss in both ears. Your hearing loss must have developed after you learned to speak (from age six or older). You also need to have tried conventional hearing aids and found that you still struggle to understand speech without relying on lip-reading.

This study will not be suitable if you have had past ear surgeries that damaged the inner ear, or if you have problems with your hearing nerve. People with certain physical ear conditions, an allergy to silicone, or another active medical device (such as an adjustable shunt in the brain) cannot take part.

Before you join, a specialist hospital team will carry out detailed hearing tests, health checks, and scans to confirm whether having a cochlear implant is safe and medically appropriate 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.

  1. You are aged 18 or older.
  2. You have severe or profound hearing loss in both ears.
  3. Your hearing loss started after you learned to speak (age 6 or older).
  4. Hearing aids no longer help you understand speech clearly.
  5. You do not have other active implanted devices, such as a magnetic brain shunt.
Answer every question to see your result.

What does participation involve?

If you decide to take part, you will have surgery at a specialist hospital to fit the Nurotron CS-30A cochlear implant. The operation is done under general anaesthetic by an experienced surgeon. Before your operation, you will attend hospital appointments for baseline hearing checks and medical scans. After the implant has healed, you will return to the clinic so the audiologist can activate and fine-tune your device. You will attend regular follow-up visits over a 12-month period. During these visits, the team will test your hearing, check device safety, and ask you to complete short questionnaires about your daily life. No experimental medications are involved, and the entire study lasts about a year from the time of your surgery.

Potential risks and benefits

Many people who receive a cochlear implant experience noticeable improvements in their hearing and find it easier to communicate with family and friends. However, benefits differ for each person and cannot be guaranteed. As with any operation, there are risks, including swelling, infection, temporary dizziness, or device issues that might require further treatment. Your clinical team will monitor you closely at every step to support your recovery. Joining this study is entirely your choice, and you can withdraw at any time without your normal medical care being affected.

Locations (4)

  • Guy's and St Thomas' NHS Foundation Trust
    City only
    London, England
  • Universitaetsklinikum Freiburg
    Approximate
    Freiburg, Germany
  • University of Valencia
    Approximate
    Valencia, Spain
  • Warsaw Institute of Physiology and Pathology of Hearing
    City only
    Warsaw, Poland

Common questions

What is a cochlear implant?

It is an electronic medical device that provides a sense of sound by directly stimulating the hearing nerve, bypassing the damaged inner ear.

Will I definitely receive an implant if I join?

Yes. Every participant who is accepted into the study will receive the Nurotron CS-30A cochlear implant system.

Does the implant surgery hurt?

The operation is carried out under general anaesthetic, so you will be asleep throughout. It is common to have some mild soreness or bruising afterwards, which can be managed with everyday painkillers.

How long will I be in the study?

You will be followed up for 12 months after your surgery to monitor your hearing progress and check device safety.

Can I leave the study if I change my mind?

Yes, taking part is completely voluntary. You are free to stop participating at any time without giving a reason, and your regular NHS care will continue as normal.

How to find out more

Dan Jiang

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

Interested in taking part?

Register your interest

Share your details and the research team for "Safety and performance of the Nurotron CS-30A cochlear impla…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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