Evaluation of safety & effectiveness Nurotron CS-30A cochlear implant
Research type
Research Study
Full title
Evaluation of safety and effectiveness the Nurotron CS-30A cochlear implant system in adults.
IRAS ID
347371
Contact name
Dan Jiang
Contact email
Sponsor organisation
Nurotron Biotechnology
ISRCTN Number
ISRCTN00046446
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
00015497 , DIMDIS
Duration of Study in the UK
1 years, 8 months, 1 days
Research summary
This study is to collect safety and performance data to support an application for CE/UKCA markings of the CS-30A cochlear implant system.
The Nurotron CS-30A is a cochlear implant system that improves hearing sensation via electrical stimulation of the hearing nerve for patients with severe to profound hearing loss who obtain limited benefit from hearing aids. It consists of two parts, an implantable cochlear receiver stimulator unit and an external sound processor.
The aim of the study is to assess safety of the device and compare within-participant sound perception and speech understanding abilities achieved with participants current hearing aids and those obtained whilst using the CS-30A cochlear implant system.The study will be a multi-centre multi-country study sponsored by Nurotron. In the UK the study will be performed at Hearing Implant Centre, Guy's and St. Thomas NHS Foundation Trust
In total 40 and at each site 4-8 participants will be recruited.
To assess safety, all adverse events will be monitored and evaluated through a Data Safety Monitoring Board (DSMB) and Clinical Event Committee (CEC) to adjudicate independently of any device related adverse events.
To assess performance we will collect data during four standard practice audiology appointments at 1, 3, 6 and 12 months after implantation as well as at an assessment appointment pre-implantation. At each appointment the device will be adjusted and three hearing perception tests will be performed. These tests will consist of listening and responding to several lists of words and sentences.
The assessment process and surgery for potential recipients otherwise will be as per standard practice at NHS hearing implant centres as will their long term follow-up care after the study concludes.
Statistical analysis suitable for assessing within-patient benefit will be used to determine efficacy of the CS-30A cochlear implant system using speech testing results from the 6 month post-activation appointment.REC name
London - Dulwich Research Ethics Committee
REC reference
24/LO/0903
Date of REC Opinion
16 Jan 2025
REC opinion
Further Information Favourable Opinion