Well actually, I can get by, although it’s not perfect. Is it worth having surgery when I don’t know if it will be better?
Currently we don’t know if a hearing aid or a cochlear implant will be better for you. Whilst it is possible that having CI surgery will result in better hearing than using your hearing aids, it is also possible that CI surgery will result in worse hearing. The aim of the study is to find out. Therefore, if you are getting by OK with your hearing aid right now and don't wish to accept the risks of CI surgery, you should not take part.
Well, actually, I really want a CI. But you can’t guarantee that. So, should I take part or can I drop out if I don’t get what I want?
We are seeking to recruit people who will remain in the study regardless of which treatment they are allocated (hearing aids or CI surgery). Therefore, if you have a strong preference for one or other device, and are considering dropping out if you don’t get the device you want, then we would not advise you to take part in this study.
Why would I keep my own hearing aids?’, ‘What are the differences between the hearing aids I have got and the hearing aids that you are offering?’ why would I keep them after going through the whole CI assessment.
For some people, using hearing aids that they are used to is important and they do not like changes to either the aids or how they are set up. Others may appreciate the opportunity to try new hearing aids to see if they offer any improvement for their hearing. For this study either approach is acceptable, and if you were to take part you would be free to make this choice between your existing hearing aids and the trial hearing aids.
The purpose of this study is not to compare different hearing aids, but to compare the outcomes of participants who continue using hearing aids to the outcomes of participants who are randomised to receive a cochlear implant. The audiologists working on the trial will ensure that all hearing aids are appropriately fitted, no matter which hearing aids are used (existing or new).
Unfortunately not. To understand if a hearing aid or CI is better for people with hearing loss like yours, we need to ensure that you do not swap the device that you have been allocated in the study.
The risks associated with Cochlear implant surgery include, facial weakness, altered taste, loss of normal hearing in that ear, device failure, incomplete electrode insertion, need for revision surgery, dizziness, imbalance, wound infection, and meningitis and restrictions on the use of MRI scanning. However, fortunately, these risks are uncommon.
This study/project is sponsored by the University of Nottingham and co-ordinated by Nottingham Clinical Trials Unit.
COACH is an NIHR portfolio adopted, registered clinical trial, sponsored by the University of Nottingham. ISRCTN 15352106. IRAS project ID 297574.