At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- Mix of remote tasks and in-person visits
- Drug or intervention
- Both EARS training package (BEARS) (other), Usual Care (other)
- How long the study runs
- Study runs about 39 months (dates as stated)
- About the drug or intervention
- Both EARS training package (BEARS) — other: The BEARS training package comprises of three games addressing different hearing functions: speech-in-noise perception, music listening and sound-source localisation. · Usual Care — other: This is an annual review appointment with the patient and their clinician.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 8 Years to 16 Years
- Who
- All
- Number of participants
- 272
- Started
- 2023-07-27
- Last checked
- 2026-03
Plain English Summary
What is this study?
- • Testing a new treatment for hearing loss, sensorineural
- • NA - 272 participants
- • The goal of the BEARS clinical trial is to determine whether using the directional listening training delivered via 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 cochlear implants
Who can take part?
- • Ages 8 Years to 16 Years
- • Diagnosed with hearing loss, sensorineural
Where?
- • Birmingham - The Midlands Hearing Implant Programme (Children's Service)
- • Bradford - Yorkshire Auditory Implant Service
- • Cambridge - Emmeline Centre for Hearing Implants
- • Kilmarnock - Scottish Cochlear Implant Programme
- • +9 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The goal of the BEARS clinical trial is to determine whether using the directional listening training delivered via 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 cochlear implants. The 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.
More detail
Deafness is the most frequent human sensory deficit. Cochlear implantation is the primary intervention. Currently over 6000 people have bilateral cochlear implants in the United Kingdom, 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. Our '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, we 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 trial is to determine whether using the directional listening training delivered via 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 cochlear implants. The study will be carried out in clinical cochlear implant departments in National Health Service or University hospitals. Participants will be randomly allocated into one of two groups: 1. Receiving the BEARS training package to use for 3-months alongside usual care 2. Continue with usual care The 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 qualitative or process evaluation interviews, which are BEARS sub-studies
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 8 Years - 16 Years
- Who can join: All genders
What the study is looking for
- ✓Participant is a simultaneous or sequential bilateral cochlear implant user\*, who either has:
- ✓Congenital severe/profound bilateral sensorineural hearing loss and have received at least one implant ≤ 36 months...
- ✓Participant has stable programmes (defined as no longer using progressive programmes to work through).
- ✓Participant is aged 8-16 years, inclusive.
Who cannot take part
- ✗Participant (or parent/legal representative) does not speak/understand English sufficiently to undertake assessments.
- ✗Participant has an intellectual disability at a level that would prevent their ability to understand the trial the...
- ✗Participant has a comorbid condition impacting ability to participate in the intervention and/or outcome assessment.
- ✗Participant has an audiological profile impacting ability to participate in the intervention and/or outcome assessments.
- ✗Participant is actively participating in other trials that may affect hearing outcomes or impact their ability to...
See the full criteria
Where Is This Study? (13 UK sites)
The Midlands Hearing Implant Programme (Children's Service)
Birmingham B4 7ET, United Kingdom
Yorkshire Auditory Implant Service
Bradford BD9 6RJ, United Kingdom
Emmeline Centre for Hearing Implants
Cambridge CB2 0QQ, United Kingdom
Scottish Cochlear Implant Programme
Kilmarnock KA2 0BE, United Kingdom
St Thomas' Hospital Hearing Implant Centre
London SE1 7EH, United Kingdom
St George's Auditory Implant Service
London SW17 OQT, United Kingdom
Auditory Implants: Royal National ENT and Eastman Dental Hospitals
London WC1E 6DG, United Kingdom
Great Ormond Street Cochlear Implant Programme
London WC1N 3JH, United Kingdom
Main Email: Research.Governance@gosh.nhs.uk
Research.Governance@gosh.nhs.uk0207 905 2700The Richard Ramsden Centre for Hearing Implants
Manchester M13 9WL, United Kingdom
North East Regional Cochlear Implant Programme
Middlesbrough TS4 3BW, United Kingdom
Rishma Bhatti, Head of Research (Mount Vernon Cancer Centre)
mvccresearch.enh-tr@nhs.net0203 826 2068 / 2069Nottingham Auditory Implant Programme
Nottingham NG1 5DU, United Kingdom
Oxford Auditory Implant Centre
Oxford OX3 9DU, United Kingdom
University of Southampton Auditory Implant Service
Southampton SO17 1BJ, United Kingdom
How to Get in Touch
Debi Vickers, PhD
Sponsor contactCONTACT
Liz Arram, MSc
Sponsor contactCONTACT
