Safety and performance of the Nurotron CS-30A cochlear implant system in adults with hearing loss
| ISRCTN | ISRCTN98976493 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98976493 |
| Integrated Research Application System (IRAS) | 347371 |
| Sponsor | Nurotron Global SARL |
| Funder | Nurotron Global SARL |
- Submission date
- 10/06/2026
- Registration date
- 15/06/2026
- Last edited
- 11/06/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Ear, Nose and Throat
Plain English summary of protocol
Background and study aims
Some adults have severe to profound hearing loss in both ears and do not gain enough benefit from hearing aids. A cochlear implant is a medical device that can help people hear sounds by directly stimulating the hearing nerve.
This study aims to look at how safe the Nurotron CS-30A cochlear implant system is and how well it helps adults hear following implantation. The information collected will help doctors understand how the device performs when used in routine clinical practice.
Who can participate?
Adults under 18 years and older with sever to profound hearing loss in both ears may be able to take part. Participants must meet the usual medical criteria for cochlear implantation in the ear to be implanted. People will be assessed to confirm whether they are suitable before joining the study.
What does the study involve?
All participants in the study will receive a cochlear implant as part of their treatment. The implant surgery will be performed by experienced specialists.
Before and after implantation, participants will attend follow-up visits at the study centre. During these visits, hearing tests will be carried out and participants will be asked to complete questionnaires about their hearing and daily life. Participants will be followed for up to 12 months after implantation.
What are the possible benefits and risks of participating?
Based on previous clinical use of cochlear implants, many participants are expected to experience improvements in hearing and hearing-related quality of life after implantation. However, the degree of improvement varies between individuals and cannot be guaranteed.
As with any operation and implanted medical device, there are possible risks. These include risks related to surgery and potential device-related problems. Participants will be monitored throughout the study to check for any safety issues.
Where is the study run from?
This study is managed from specialist cochlear implant centres in Europe and will take place at centres in the United Kingdom, Germany, Spain, and Poland.
When is the study starting and how long is it expected to run for?
May 2026 to May 2027
Who is funding the study?
The study is funded by Nurotron Global SARL
Who is the main contact?
Professor Dan Jiang: dan.jiang@gstt.nhs.uk
Contact information
Principal investigator, Scientific, Public
St Thomas' Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom
| Phone | +44 207 188 6245 |
|---|---|
| dan.jiang3@nhs.net |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | N/A: single arm study |
| Masking | Open (masking not used) |
| Control | Uncontrolled |
| Assignment | Single |
| Purpose | Pre-market clinical investigation |
| Scientific title | Evaluation of safety and effectiveness the Nurotron CS-30A cochlear implant system in adults |
| Study objectives | To establish the benefits of the Nurotron CS-30A Cochlear Implant System in adults with severe-to-profound bilateral sensorineural hearing loss, including improvements in hearing performance, speech perception, and hearing-related quality of life, while monitoring safety through detailed adverse event assessment. |
| Ethics approval(s) |
Approved 16/01/2025, Dulwich Research Ethics Committee (Dulwich Research Ethics Committee, Health Research Authority, 2nd Floor, 2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 20 7104 8000; dulwich.rec@hra.nhs.uk), ref: 24/LO/0903 |
| Health condition(s) or problem(s) studied | Post-lingual severe-to-profound bilateral sensorineural hearing loss in adults |
| Intervention | This is a prospective, multicentre, single-arm interventional study. Participants will undergo implantation with the Nurotron CS-30A Cochlear Implant System in the ear selected according to study inclusion criteria. The device consists of an implantable internal unit and an external speech processor that converts sound into electrical stimulation of the auditory nerve. Following baseline assessments (aided and unaided hearing thresholds, speech perception tests, and quality-of-life questionnaire), participants will undergo cochlear implantation surgery. The external speech processor will be activated approximately 1–6 weeks post-surgery, with device fitting, programming, and rehabilitation sessions provided using the NuroSound system. Outcomes will be assessed at follow-up visits at 1, 3, 6, and 12 months after activation. Primary efficacy endpoints include aided word and sentence recognition in quiet and in noise, and secondary endpoints include hearing-related quality of life. Safety is monitored through adverse event reporting, adjudicated by an independent Data Safety Monitoring Board and Clinical Event Committee. |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | CS-30A Cochlear Implant System |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 30/11/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 40 |
| Key inclusion criteria | 1. 18 years or older 2. Post-lingual onset of severe sensory neural hearing loss (from 6 years old or older) 3. Local language proficiency 4. In the ipsilateral ear: unaided acoustic pure-tone thresholds of ≥ 50 dB HL at 500 Hz, ≥ 60 dB HL at 1000 Hz, ≥ 70 dB HL by 2000, 4000 and 8000 Hz; Marginal hearing aid benefit, defined as word recognition score of ≤ 50% in the best-aided condition at 65dB SPL without lip-reading; Duration & performance situation at base-line, sensory neural loss level ≥ 3 months stable (preferably ≥ 6 months) unless risk of imminent obliteration |
| Key exclusion criteria | 1. Previous ear surgery that could compromise the inner ear 2. Indication of a central auditory lesion or compromised auditory nerve (ideally confirmed by preoperative MRI) 3. Cochlear malformation or obstruction that would preclude full insertion of electrode array 4. Presence of additional disabilities that would prevent or interfere with participation in the required study procedures; 5. Medical or physiological conditions that contraindicate surgery or impact the ability to manage an implanted device or the study related procedures (e.g. silicone allergy) 6. Presence of magnetically adjustable CSF shunts or any active implantable medical device in the study candidate at the time of informed consent signature |
| Date of first enrolment | 12/05/2026 |
| Date of final enrolment | 15/11/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
- Germany
- Poland
- Spain
Study participating centres
Westminster Bridge Road
London
SE 1 7EH
England
Freiburg
79106
Germany
Nivell 3
Valencia
46010
Spain
Warsaw
05-830
Poland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
10/06/2026: Trial's existence confirmed by MHRA.
