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Foundation - Feasibility of conducting a randomised controlled trial to examine the benefit of bilateral cochlear implantation c

Foundation

Foundation - Feasibility of conducting a randomised controlled trial to examine the benefit of bilateral cochlear implantation c
Funding National Institute for Health Research
Portfolio Clinical Specialties
Interventions Other
Randomised No
Status Analysis/reporting
Start Date 18-Apr-2017

A cochlear implant is a device that can restore some hearing to a deaf ear. 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 these adults have difficulty understanding what people are saying even when they wear hearing aids. They have difficulty using the telephone and may be unable to hear important sounds like alarms, doorbells, and traffic. 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.
Adults with severe to profound deafness who are potential and actual recipients of cochlear implants were asked to help design a future trial. To see if this future randomised controlled trial can be conducted, adult patients completed several quality of life questionnaires at different time points post cochlear implant Surgery in addition to an acceptability questionnaire. Online surveys involving patients and clinical staff, patient focus groups, a trial design workshop with health care professionals and an industry forum were conducted in order to assess the acceptability and feasibility of the trial.

Publications

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