Both EARS training package (BEARS) to maximise hearing abilities in older children and teenagers with bilateral cochlear implants

Plain English summary of protocol

Background and study aims
Deafness is the most frequent human sensory deficit. Cochlear implantation is the primary intervention. Currently, over 6000 people have bilateral cochlear implants (CIs) in the UK, and most of these are children. Two implants are supposed to provide better access to sound, but it is challenging to interpret and integrate what is heard from both sides. The 'Living with cochlear implants' Patient and Public Involvement group reported that everyday communication is challenging and tiring, with extra effort required to integrate information from two ears, especially in noise. They reported that current rehabilitation techniques are not engaging, or appropriate to their lifestyles. To address these issues, researchers have developed a set of virtual reality games called BEARS (Both EARS). BEARS trains sound localisation and listening in noise. These are skills required in everyday listening. The aim of this study is to determine whether using the directional listening training delivered through the BEARS training package for 3 months alongside usual care compared to only receiving usual care improves speech-in-noise perception, hearing experiences, vocabulary and quality of life and reduces listening effort in young people between 8-16 years old (inclusive) with two CIs. The study will be carried out in clinical CI departments in NHS or University hospitals.

Who can participate?
Patients aged 8-16 years with severe/profound bilateral hearing loss who use bilateral cochlear implants

What does the study involve?
Participants will be randomly allocated into one of two groups:
1. Receive the BEARS training package to use for 3 months alongside usual care. This group will be given a head-mounted display or iPad with the BEARS training package pre-installed. The participants will be asked to complete the BEARS training package for a minimum of 2 x 30-minute sessions a week during the 3 months and also complete a training diary and answer some questions about the BEARS training package on a weekly basis.
2. Continue with usual care
All participants will complete hearing assessments and questionnaires before completing the 3-month intervention. They will be followed up for the next 9 months through online and in-person appointments. Participants and clinicians can also consent to interviews.

What are the possible benefits and risks of participating?
Participants who receive the BEARS training package of virtual reality games will be given training separate to usual care, which is hoped will develop and improve their hearing ability.
The BEARS training package will be carried out using either an Oculus virtual reality head-mounted display or an iPad with headphones. Both devices are licensed for everyday use. There are risks associated with using the Oculus virtual reality head-mounted display, which are detailed in the device’s safety manual on the Oculus website. The main risk associated with this trial and using the Oculus device is falling while playing the games. For this reason, all participants must play the games whilst sitting down on a chair.

BEARS Program Development Grant (PDG)
Some people may find it hard to take part in research, especially if they are from a minority community or feel excluded for other reasons. We want our research results to apply to everyone, so we want to make sure that the people who take part are similar to the population as a whole. We have an additional Program Development Grant from NIHR to look at how diverse the children involved in BEARS are, and how we can improve this.

PDG Work plan
We will look at the children who have agreed to take part in the first 6 months of BEARS and see if they are similar to the UK population of deaf children with implants. We will look at their ethnicity, socioeconomic status, home language, sex, number of siblings, and parent/carer educational level. However, first we will need to look at lots of different information sources to find out about the diversity of deaf children in the UK, as this is not known at the moment. We can then compare with the children recruited to BEARS and see which groups are not being included. We will hold a workshop for the BEARS team and the clinicians at the participating centres to plan how to make recruitment fairer for the rest of the trial. We will then interview children and parents who chose not to take part in BEARS and find out what put them off. We will also talk to clinicians, teachers and other family representatives to ask their opinions on what makes it difficult to be involved in BEARS. We can then plan to make the BEARS NHS roll-out after the trial more inclusive. We hope this may also help other researchers to include a more diverse population of families with deaf children in future.

Where is the study run from?
Guy’s and St Thomas’ NHS Foundation Trust and UCL’s Comprehensive Clinical Trials Unit (CCTU) (UK)

When is the study starting and how long is it expected to run for?
January 2021 to December 2026

Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK)

Who are the main contacts?
1. Debi Vickers, dav1000@medschl.cam.ac.uk
2. Liz Arram, cctu.bears@ucl.ac.uk

Contact information

Dr Deborah Vickers
Principal investigator

University of Cambridge
SOUND Lab
Clinical Neuroscience Department
Herchel Smith Building
Cambridge Biomedical Campus
Cambridge
CB2 0SZ
United Kingdom

ORCID ID	0000-0002-7498-5637
Phone	+44 (0)1223760683
Email	dav1000@medschl.cam.ac.uk

Dr Deborah Vickers
Scientific

University of Cambridge
SOUND Lab
Clinical Neuroscience Department
Herchel Smith Building
Cambridge Biomedical Campus
Cambridge
CB2 0SZ
United Kingdom

Phone	+44 (0)1223760683
Email	dav1000@medschl.cam.ac.uk

Ms Liz Arram
Public

Comprehensive Clinical Trials Unit at UCL
Institute of Clinical Trials and Methodology
90 High Holborn
London
WC1V 6LJ
United Kingdom

Phone	+44 (0)20 3108 8059
Email	cctu.bears@ucl.ac.uk

Study information

Eligibility

Locations

Countries of recruitment

• United Kingdom
• England

Study participating centres

Results and Publications

Study outputs

Editorial Notes

24/07/2025: The following changes were made:
1. The target number of participants was changed from 384 to 272.
2. The date of final enrolment was changed from 30/07/2025 to 31/07/2026.
3. The completion date was changed from 31/12/2025 to 31/12/2026.
4. The intention to publish date was changed from 31/12/2026 to 31/12/2027.
16/04/2025: The recruitment end date was changed from 30/04/2025 to 30/07/2025.
04/02/2025: Plain English summary updated.
03/12/2024: Ethics approval details added.
02/12/2024: The following changes were made to the study record:
1. The exclusion criteria were updated.
2. The recruitment end date was changed from 31/12/2024 to 30/04/2025.
3. University of Southampton Auditory Implant Service, Great Ormond Street Hospital, Cochlear Implant Programme, UCLH, Auditory Implants Programme, St George's Hospital, Auditory Implant Service, Birmingham Paediatric Cochlear Implant Programme, Nottingham Cochlear Implant Programme, Oxford Auditory Implant Programme, The Scottish Cochlear Implant Programme, North East Regional Cochlear Implant Programme, Belfast Auditory Implant Centre, Manchester Royal Infirmary, Cochlear Implant Department, and Yorkshire Auditory Implant Service were added to the study participating centres.
21/02/2023: Trial's existence confirmed by the NIHR.