Feasibility of a trial of bilateral cochlear implantation in adults
Research type
Research Study
Full title
Feasibility of conducting a randomised controlled trial to examine the benefit of bilateral cochlear implantation compared with unilateral cochlear implantation in adults with severe to profound deafness
IRAS ID
213342
Contact name
Natalie McGregor
Contact email
Sponsor organisation
Nottingham University Hospitals NHS Trust
Duration of Study in the UK
1 years, 3 months, 31 days
Research summary
In the UK, cochlear implantation is the standard treatment for adults with ‘severe-to-profound’ deafness. This level of deafness means that without a cochlear implant they have difficulty understanding what people are saying even when they wear hearing aids. The NHS provides a cochlear implant for one ear even though these adults are deaf in both ears. Two cochlear implants could help them understand speech in noisy environments, know where to look to see who is talking, and avoid hazards outdoors.
The decision about who can receive cochlear implants and how many they can receive is based on guidance from the National Institute for Health and Care Excellence (NICE). NICE agreed that providing two cochlear implants can provide additional benefits over providing just one implant. However, they decided that there is not enough evidence to show that these additional benefits are worth the additional cost of providing the second implant. NICE recommended that a clinical trial should be conducted to gather this evidence.
This study will gather information to see if the trial recommended by NICE could be conducted in the future. The study will involve adults with severe-to-profound deafness who have been offered a cochlear implant by an NHS service provider in the UK but who have not yet had their implant surgery. These participants will be provided with information about the trial recommended by NICE. They will then be asked what they think about it and if they think other patients like them would be willing to take part. These participants will also be asked to complete questionnaires before and after they receive their cochlear implant. The data from these questionnaires will help us to find out how many participants would need to be recruited into the future trial that NICE recommended.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
17/WM/0413
Date of REC Opinion
22 Dec 2017
REC opinion
Further Information Favourable Opinion