Designing a trial of bilateral cochlear implantation in adults
Research type
Research Study
Full title
Designing 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
224847
Contact name
Pádraig Kitterick
Contact email
Sponsor organisation
Nottingham University Hospitals NHS Trust
Duration of Study in the UK
1 years, 10 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 consult with patients to explore whether the trial would be acceptable to future implant recipients. The study will also work with clinicians to design a trial comparing bilateral and unilateral implantation in adults. These clinicians will also be surveyed to assess the acceptability of the trial. A group of clinicians that span the range of professions involved in delivering the care pathway will be invited to attend a trial design workshop to establish a consensus on acceptable trial design elements from a clinical perspective. Representatives from cochlear implant manufacturers will be consulted to determine possible strategies for securing industry support for a future trial. Those who run cochlear implantation services will be engaged in a working group to gather information on the current care pathway to inform future assessments of whether bilateral implantation could be cost-effective.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
17/SW/0124
Date of REC Opinion
8 Jun 2017
REC opinion
Further Information Favourable Opinion