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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Mrs Imogen Parker
+44 (0)7773 206 747
coach@nottingham.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

Study Location:

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Be Part of Research - Trial Details - Comparing cochlear implants with hearing aids in adults with severe hearing loss

Comparing cochlear implants with hearing aids in adults with severe hearing loss

Recruiting

Open to: All Genders

Age: Adult

Medical Conditions

Severe hearing loss


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


In the UK, cochlear implants are provided to some people with severe or profound hearing loss who do not get enough benefit from their hearing aids. Cochlear implants can improve their ability to recognise sounds and understand speech. Currently, only these adults are offered a cochlear implant on the NHS.
This study aims to find out whether some adults who are not currently offered a cochlear implant on the NHS would benefit more from a cochlear implant than they would from using hearing aids alone. These people are those whose hearing or speech test results are just outside of the range that would make them eligible for a cochlear implant on the NHS. It is not known if cochlear implantation is a good treatment option compared to hearing aids for these people.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

04 Oct 2021 31 Aug 2025

Participants are randomly allocated to receive a cochlear implant or new hearing aids (or can choose to continue to wear their own). The researchers will compare how well the two groups can understand speech after 9 months.


Patients aged 18 years and over with severe hearing loss

You can take part if:



You may not be able to take part if:


1. Patient characteristics falling outside the indications for use of the trial devices as per their CE marking2. Inability to undergo speech perception testing and/or inability of audiologist to obtain an accurate measurement of speech perception abilities3. Patients who would not be able to adhere to trial procedures or complete the trial questionnaires4. Patients whose hearing loss is suspected or confirmed to be wholly or partly unexplained by anatomic or physiologic abnormalities (non-organic hearing loss)5. Patients who have a congenital severe hearing loss6. Any known factor that may restrict the full insertion of the electrode array7. Patients with any known contraindication for cochlear implantation8. Patients whose primary concern is the suppression of tinnitus 9. Patients in whom cochlear implantation would present an unacceptable risk to balance function10. Any serious concerns about medical fitness for surgery or cochlear implantation11. Participation in other research related to hearing loss while participating in the trial (i.e., until collection of primary outcome), including research that involves any changes to or use of hearing devices, changes to hearing care/management, or duplication of trial outcome assessments


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Cardiff & Vale University Lhb
    Woodland House Maes-y-coed Road
    Cardiff
    CF14 4HH
  • Queen Elizabeth Hospital
    Mindelsohn Way Edgbaston
    Birmingham
    B15 2GW
  • Queens Medical Centre
    Derby Road
    Nottingham
    NG7 2UH
  • St George's Hospital
    Blackshaw Road Tooting
    London
    SW17 0QT
  • The James Cook University Hospital
    Marton Road
    Middlesbrough
    TS4 3BW
  • University College London Hospital
    250 Euston Road
    London
    NW1 2PG
  • Bradford Royal Infirmary
    Duckworth Lane
    Bradford
    BD9 6RJ
  • St Thomas' Hospital
    Westminster Bridge Road
    London
    SE1 7EH
  • Manchester Royal Infirmary
    Oxford Road
    Manchester
    M13 9WL

Both treatments in this study 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. For the cochlear implant group some risks following surgery may include potential loss of the natural hearing the patient had before (meaning that the patient might not be able to go back to using a hearing aid if they weren’t happy with the cochlear implant), temporary facial weakness, tinnitus, meningitis, pain and discomfort, as well as the normal risks associated with surgery and general anaesthesia. For the hearing aid group the risks may include pain and discomfort from the use of the new hearing aids, ear infections and exacerbation of eczema.

Mrs Imogen Parker
+44 (0)7773 206 747
coach@nottingham.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by University of Nottingham and funded by Cochlear.




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Read full details for Trial ID: ISRCTN15352106

Or CPMS 50095

Last updated 21 August 2024

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