In the trial, we are looking to recruit 130 adults with severe hearing loss. Half of the people will receive a cochlear implant, and the other half will receive new hearing aids (or can choose to continue to wear their own). People will be randomly assigned (by a computer) to one of the two groups.  Though we don’t know if either treatment might be better than the other, we know enough about the safety and potential benefits of both treatments to believe it is appropriate to offer either option to people in this trial.  Whatever group you are randomly put in by the computer, a doctor will first confirm beforehand that either treatment would be a safe and appropriate option for you. 

After all trial data is collected from all people, we will compare how well the two groups can understand speech after 9 months.

This trial plans to recruit a total of 130 people at 9 different NHS hospitals across the UK. To be eligible, we will need to check your current level of your hearing loss, how well you understand speech, and whether you are suitable for cochlear implant surgery. Taking part is entirely voluntary and it is completely up to you whether or not you take part in the trial.  Before you decide, it is important for you to understand why we are doing the trial and what it involves. 

Click here to download the Participant Information Sheet for more information.

If you are still eligible after these first checks, you will then start the COACH eligibility pathway. This will include several appointments and will follow the same procedures that all patients being considered for a cochlear implant would receive at your clinic. These could vary between hospitals and is to ensure you are fit and well enough to receive a CI if that is the group you are allocated to. The researcher will explain to you what further visits you will have.  One of these visits will include an MRI or CT scan to check that your inner ear (cochlear) is suitable for cochlear implantation. Other appointments also include counselling, to ensure that you understand the changes in your hearing that a cochlear implant may provide and what learning to hear with a cochlear implant involves, offer you support, give you the opportunity to ask questions, and ensure you would be happy to go ahead with surgery if you were offered a cochlear implant as part of the trial. Only people who are confirmed as both eligible for the trial and eligible for a cochlear implant after going through the COACH eligibility pathway would be invited for a treatment allocation appointment. If you are not eligible for the trial, your care will continue as normal under the NHS. The information collected up to this point will still be kept.

If you are eligible for the trial, you will randomly put you in one of the two groups (hearing aid group or cochlear implant group). You will have a 50% chance of being in either group, like flipping a coin. This ensures there is a fair comparison between the two groups. Neither you, the clinical team nor the research team can choose which group you will be allocated to, as this could lead to the groups being unequal and the results of the trial being unreliable. We currently do not know which treatment will give better results which is why we need to compare the groups fairly. 

Hearing aid group: 

If you are in this group, you will continue to use hearing aids in both ears and you will not receive a cochlear implant. The hearing aids offered as part of this trial are from the danalogic GN Ambio Smart range. The decision of which hearing aids you receive will be discussed between you and the clinical team. You will have the choice of being fitted with these state-of-the-art hearing aids, or you can opt to keep your current hearing aids. If you keep your current hearing aids, an audiologist will check to make sure they are set up in the best way for you. Fitting of the new hearing aids, or adjusting your current hearing aids, will happen within 3 months of your treatment allocation appointment.

Support: You will be offered remote follow-on support within 1 week of your fitting/adjustment appointment to discuss and solve any initial difficulties you may have. Ongoing support will be provided throughout the whole trial, but if you have opted for new hearing aids, we will also take care of all repairs and replacements for up to 2 years after you receive the hearing aids.  After the trial is finished, the new hearing aids are yours to keep, and you will continue with your normal NHS care.

Cochlear implant group: 

If you are in this group, you will need to provide consent for surgery. You will receive a cochlear implant in one ear and the clinical team will discuss the choice of ear to be implanted with you. Prior to surgery you will be offered a new hearing aid for the ear that is not being implanted, or if you choose to keep your own hearing aid, we can make sure that this is set up in the best way for you. All other information about hearing aid fitting and maintenance is the same in this group as for the hearing aid group.

Hearing aid fitting/adjustment appointment: You will be offered a new hearing aid for the ear that is not being implanted, or if you choose to keep your own hearing aid, we can make sure that this is set up in the best way for you. All other information about hearing aid fitting and maintenance is the same in this group as detailed above for the hearing aid group.

Implant surgery: The cochlear implant surgery will take place within 3 months of your treatment allocation appointment. You will need an x-ray or CT scan to check the implant has been correctly inserted. You will usually be able to go home on the same day as your surgery, although in some cases (for example if your surgery is later in the day) an overnight stay may be required. Following the surgery there is a wait before implant activation. During this time, you would not be able to use your hearing aid in the implanted ear. If you use a hearing aid in the other ear, you can use that during this time. Surgery will follow routine NHS practices and more information about it will be discussed with you by the clinical team during your appointments. There may be additional imaging as part of routine care.

Implant activation: You will attend an appointment approximately 1 month after your surgery to turn the cochlear implant on.Your implant will be programmed for you over several appointments over the following weeks and months in line with your cochlear implant centre’s standard care.

There will be a choice of which sound processor (the external part of the cochlear implant) you can have, from the options which are included in the trial. The decision of which you receive will be discussed between yourself and the clinical team.

Sound Processor Models currently included in the trial: Cochlear™ Nucleus® 7, Cochlear™ Nucleus® 8, Cochlear™ Kanso® 2.

Support: It is important to know that learning to hear with a cochlear implant takes time and practice. It is very different to adapting to new hearing aids. Once your cochlear implant has been switched on, you will have access to the standard rehabilitation services your cochlear implant service provides. This will vary from site to site and may be offered in-person or online. Rehabilitation services may include any or all of the following: counselling about adapting to cochlear implant sound, listening practice exercises, communication tactics training, support groups, telephone training, and technology such as apps for listening practice and hardware such as remote microphones.

If you have a hearing aid for the non-implanted ear, you will also be offered the same hearing aid support as the hearing aid group, which is detailed above. 

Follow-up:

All follow-up timepoints are scheduled from the time of hearing aid fitting/adjustment (hearing aid group) or when your cochlear implant was activated (cochlear implant group). Contact and appointments after hearing aid fitting/implant activation will be the same for both groups, as detailed below. If you are in the cochlear implant group, these research appointments will be in addition to your clinical cochlear implant rehabilitation appointments but will wherever possible these will be scheduled on the same day to limit your visits to clinic.

1-month: You will be sent a questionnaire booklet in the post. These will be the same questionnaires that you completed at your treatment allocation visit. They can be done in your own time.

3-, 6- and 9-months: At these appointments, an audiologist will test your hearing and ask you to complete the same speech tests and questionnaires as you did at your treatment allocation visit.

Monthly checks: On the months we aren’t seeing you in person for a visit, or posting questionnaires to you (months 2, 4, 5, 7 and 8), you will be contacted by a researcher to check how well your hearing aids/cochlear implants are working, how often you are using them and if you are having any problems. 

Additional information about taking part:

Video Recordings:

Video recordings will be made of you doing one of the speech tests during the trial. These recordings will take place on two occasions:

• Before you start your treatment (at the treatment allocation appointment)

• During your final 9-month follow up appointment

The videos will be taken head-on so that the type of hearing device(s) you are using cannot be seen. This is so that independent audiologists who do not know which group you are in can score the tests, making sure our trial results are fair. These recordings will be transferred digitally to the Nottingham Clinical Trials Unit and saved securely and confidentially with the rest of the trial data. The independent audiologists will only have access to these videos on secure databases, using password protected systems. Recordings will be stored for at least 7 years, after which your data will be disposed of securely and your confidentiality will be protected in line with the UK Data Protection Act.

Optional Interviews:

A small group of people will also be asked to take part in interviews about their views of cochlear implantation. This is optional and will be covered by a separate information sheet. Written quotations from the interviews will be anonymised and may be used in publications and presentations.

Recruitment Study:

Researchers from the University of Nottingham would like to audio-record some of the conversations that healthcare professionals have with people about whether they want to take part in the COACH trial. This is to help us understand how this trial and the treatments are being explained to potential participants and if there are any improvements we can make. There is a separate information sheet to provide details about this. We would need your permission before audio-recording any conversations and it is entirely up to you if you are happy for these conversations to be recorded or not. It will not affect your participation in the trial.

There is no guarantee that taking part in this trial will directly benefit you. Both new hearing aids/adjusting your current hearing aids and cochlear implants may provide an improvement in your hearing, but it is not known if this will be the case. The information we collect from this trial may help us to improve treatment for people with hearing loss like yours in the future and help us understand the condition better. If you are in the cochlear implant group, you will receive a cochlear implant in one ear that would not be available to you on the NHS at the time of the trial, and you will have the option to use a new hearing aid in your other ear or have your current hearing aid adjusted. If you are in the hearing aid group, you will have the option to receive new state-of-the-art hearing aids or have your current hearing aids adjusted.

Both treatments in this trial are already available as standard NHS procedures but only for people who meet the current NHS eligibility criteria. Like any treatment, both have possible disadvantages and risks. If you are confirmed as eligible, then the clinical team involved in your treatment will have already decided that either treatment is a safe and suitable option for you and are happy for you to take part in this research.

To read more about this please see the participant information sheet. 

You can stop being part of the trial at any time, without giving a reason, but we will keep information about you that we have already collected up to that point. We may also use data we collect in this trial for future research. After at least 7 years the data collected during the trial will be disposed of securely. If you give us your permission, we may keep your contact details so we can get in touch if there is any relevant future research to do with your hearing loss that you may be interested in taking part in. 

For more information about your rights involving your data, please see the University of Nottingham Privacy Notice which explains how your personal data is processed and the rights you have with respect to your personal information: https://www.nottingham.ac.uk/utilities/privacy/privacy.aspx.

When the trial ends for you, your healthcare will continue as normal. For up to 2 years after receiving your new hearing aids and/or cochlear implant, ongoing support will be provided for adjustments or repairs. After this period, your care will continue under the NHS. At the end of the trial, we will review and analyse all the data collected, and the results will be published in scientific medical journals and presented at conferences. You will not be identified in any publication. We will send you a newsletter with a summary of the trial results unless you ask us not to.

The anonymised results will be shared with government departments so that they will have better information on which to base their guidance for which adults in the UK should be offered cochlear implantation. The results will also be shared with hearing care professionals across the public and private sectors, via professional bodies, international conferences, and scientific publications. In this way, we hope the results will help adults with severe hearing loss receive the best possible care. This is the first randomised clinical trial of cochlear implants for adults with severe hearing loss, and so the results will be internationally relevant, and could optimise the provision of hearing aids and cochlear implants around the world.