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BEARS Training Package to Maximise Hearing Abilities in Older Children and Teenagers With Bilateral Cochlear Implants

Sponsor: Guy's and St Thomas' NHS Foundation Trust

NCT ID: NCT05808543

View on ClinicalTrials.gov ↗

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

Hearing Loss, SensorineuralHearing LossDeafnessHearing Impaired Children and Adolescents

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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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
Inclusion Criteria: 1. Participant is a simultaneous or sequential bilateral cochlear implant user\*, who either has: 1. Congenital severe/profound bilateral sensorineural hearing loss and have received at least one implant ≤ 36 months of age. 2. Progressive or acquired severe/profound bilateral sensorineural hearing loss (no age at implant restrictions for these patients) \*(a bilateral CI user is defined as a patient who uses both cochlear implant processors for a minimum of 6-hours per day over a month) 2. Participant has stable programmes (defined as no longer using progressive programmes to work through). 3. Participant has had at least two usual care checks/clinical appointments with stable aided levels (+/- 10 dB across 500Hz-4kHz) and no progressive maps to still work through, if they have had re-implantation of internal implant devices. 4. Participant is aged 8-16 years, inclusive. Exclusion Criteria: 1. Participant (or parent/legal representative) does not speak/understand English sufficiently to undertake assessments. 2. Participant has an intellectual disability at a level that would prevent their ability to understand the trial the intervention or assessment questions. 3. Participant has a comorbid condition impacting ability to participate in the intervention and/or outcome assessment. 4. Participant has an audiological profile impacting ability to participate in the intervention and/or outcome assessments. 5. Participant is actively participating in other trials that may affect hearing outcomes or impact their ability to participate in the intervention. 6. Participant is currently or anticipated to receive treatment and/or intervention that may affect hearing outcomes or adapt implant settings/programming. 7. Participant is refusing to consent to trial activities/protocol. 8. Participant is awaiting reimplantation following device failure or infection. 9. Participant is a non-user of one or both implant processors (i.e., must use both processors for a minimum of 6 hours per day over a month). 10. Participant is a fulltime boarder at a boarding school 11. Participant has unresolvable issues found in device checks that render one of the implants unusable. 12. Participant is a female that is pregnant. 13. Participant has a diagnosis of epilepsy or history of seizures of any kind.

Where Is This Study? (13 UK sites)

The Midlands Hearing Implant Programme (Children's Service)

Birmingham B4 7ET, United Kingdom

ACTIVE_NOT_RECRUITING

Yorkshire Auditory Implant Service

Bradford BD9 6RJ, United Kingdom

Recruiting

Emmeline Centre for Hearing Implants

Cambridge CB2 0QQ, United Kingdom

Recruiting

Scottish Cochlear Implant Programme

Kilmarnock KA2 0BE, United Kingdom

Recruiting

St Thomas' Hospital Hearing Implant Centre

London SE1 7EH, United Kingdom

Recruiting
Hospital R&D contact (matched)

Main Email: gstt.RandD@nhs.net

gstt.RandD@nhs.net---

St George's Auditory Implant Service

London SW17 OQT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mr Subhir Bedi

researchgovernance@sgul.ac.uk020 8725 4986

Auditory Implants: Royal National ENT and Eastman Dental Hospitals

London WC1E 6DG, United Kingdom

Recruiting

Great Ormond Street Cochlear Implant Programme

London WC1N 3JH, United Kingdom

Recruiting
Hospital R&D contact (matched)

Main Email: Research.Governance@gosh.nhs.uk

Research.Governance@gosh.nhs.uk0207 905 2700

The Richard Ramsden Centre for Hearing Implants

Manchester M13 9WL, United Kingdom

Recruiting

North East Regional Cochlear Implant Programme

Middlesbrough TS4 3BW, United Kingdom

Recruiting
Hospital R&D contact (matched)

Rishma Bhatti, Head of Research (Mount Vernon Cancer Centre)

mvccresearch.enh-tr@nhs.net0203 826 2068 / 2069

Nottingham Auditory Implant Programme

Nottingham NG1 5DU, United Kingdom

Recruiting
Hospital R&D contact (matched)

Alison Lloyd

nuhnt.researchsponsor@nhs.net0115 9249924

Oxford Auditory Implant Centre

Oxford OX3 9DU, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research Support Team

research@oxfordhealth.nhs.uk01865 902401

University of Southampton Auditory Implant Service

Southampton SO17 1BJ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Mikayala King

researchmanagement@uhs.nhs.uk023 81208215

How to Get in Touch

Debi Vickers, PhD

Sponsor contact

CONTACT

01223 760683 dav1000@medschl.cam.ac.uk

Liz Arram, MSc

Sponsor contact

CONTACT

cctu.bears@ucl.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2026-03