An interventional study of Both EARS training package (BEARS) and Usual Care in Hearing Loss, Sensorineural, Hearing Loss and Deafness, sponsored by Guy's and St Thomas' NHS Foundation Trust. Recruiting at 13 sites in United Kingdom. Open to participants aged 8 Years to 16 Years. Per ClinicalTrials.gov, last updated 2026-04-01.
Sponsored by Guy's and St Thomas' NHS Foundation Trust · Not applicable, Interventional, and Treatment
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.
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:
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
Participant is a simultaneous or sequential bilateral cochlear implant user*, who either has:
Exclusion Criteria:
BEARS is a compilation of virtual reality games designed specifically for young people with bilateral cochlear implants. The hardware is either: A Head Mounted Display Device or an iPad with headphones.
Other: Both EARS training package (BEARS) · Other: Usual Care
Usual care describes the routine rehabilitation received by participants via their implant centre.
Other: Usual Care
The BEARS training package comprises of three games addressing different hearing functions: speech-in-noise perception, music listening and sound-source localisation. Each game is based on an audio-visual task performed through a virtual-reality interface. Players are guided through on-screen visual prompts to support the gameplay with feedback given on their performance and progress through levels of increasing difficulty. The BEARS training package design allows for the training to be self-administered, played anywhere and at any time. There is no upper limit to the frequency of use of the BEARS training package, it is advised to play the games for a minimum of 1 hour a week over a minimum of 2x 30-minute sessions, all three games will need to be played.
This is an annual review appointment with the patient and their clinician. This could be face-to-face, virtual video consultation, questionnaire, or be cochlear remote care checks. As a minimum this review will check the following: Microphone covers changed, Reported or recorded device use, all external and internal equipment working (known through no reported or recorded degradation in hearing ability). During the appointment, the clinician would establish if there were any concerns regarding the cochlear implant functioning and the patient's rehabilitation programme. They will then make any repairs or adjustments to the device and manage additional support and contact as required. Between the annual review appointments patients can attend the implant centre for repair appointments or have spare equipment posted. There is no limit to the level of contact between the patient and the implant centre.
Spatial speech in Noise - Virtual Acoustics (SSiN-VA) test outcome
The Primary outcome for the BEARS trial is the difference between the intervention groups in speech-in-noise perception score (% correct overall task) at 3 months, accounting for the participant's baseline score. This is derived from the spatial speech in noise (SSiN-VA) test.
Time frame: Three months
SSiN-VA test outcome
Speech-in-noise perception score (% correct of the overall task) at twelve months accounting for the baseline score.
Time frame: Twelve months
SSiN-VA test outcome
Relative localisation score (% correct) at three months and at twelve months accounting for the baseline score.
Time frame: Three and Twelve Months
Spatial Adaptive Sentence List (Sp-ASL) test outcomes
Speech reception threshold at three months and at twelve months, accounting for baseline (for better ear, worse ear, and average of both).
Time frame: Three and Twelve Months
British Picture Vocabulary Scale (BPVS) test outcome
Difference between arms in vocabulary age at twelve months, accounting for baseline vocabulary age
Time frame: Twelve Months
Vanderbilt Fatigue Scale: Child self-report version (VFS-C) questionnaire outcome
Difference between arms in listening-related fatigue score at three and 12 months, accounting for baseline.
Time frame: Three and Twelve Months
Speech, Spatial, and Qualities of Hearing Scale for Children with Impaired Hearing (SSQ) outcome
Difference between arms in SSQ scores at three and 12 months, accounting for baseline.
Time frame: Three and Twelve Months
Health Economic outcomes
The economic evaluation will calculate incremental cost per quality-adjusted life-year (QALY) gained by offering BEARS and usual care, compared to usual care, from an NHS, Personal Social Services (PSS) and Local Education Provider perspective over the twelve months of the trial.
Time frame: Twelve Months
SSiN-VA test outcome
Average reaction time (measure of listening effort) for word identification selections at three months and at twelve months accounting for the baseline score.
Time frame: Three and Twelve Months
SSiN-VA test outcome
Average reaction time (measure of listening effort) for location shift selection at three months, and at twelve months accounting for the baseline score.
Time frame: Three and Twelve Months
SSiN-VA test outcome
Spatial index for word identification at three months and at twelve months accounting for the baseline score.
Time frame: Three and Twelve Months
SSiN-VA test outcome
Spatial index for relative localisation at three months and at twelve months accounting for the baseline score.
Time frame: Three and Twelve Months
Spatial Adaptive Sentence List (Sp-ASL) test outcomes
Spatial release from masking score at three months and at twelve months, accounting for baseline (for better ear, worse ear, and average of both).
Time frame: Three and Twelve Months
Age effects
No further data will be collected for the age effect analyses but the data regarding the trajectory of the children's speech-in-noise scores relative to normative age range for the speech measures will be assessed to determine if there is a difference in trajectory over time between the BEARS intervention and Usual Care groups.
Time frame: Twelve Months
Retention of training effects
No further data will be collected for the retention effect analyses. It is considered best practice in training interventions to evaluate if the training effects remain after the intervention period has finished. For this analysis fixed effects of timepoint (baseline, 3, 6, 9 and 12 months) and group (BEARS intervention, Usual care) and random effect of participant will be used to understand the speech-in-noise outcomes.
Time frame: Three and Twelve Months
Impact of degree of balance between ears
For this analysis, the balance app will be used to indicate the degree of symmetry across the two ears. The balance measurements at baseline, three months and 12 months will be used as an outcome to determine if there have been any changes in the balance between the ears over time.
Time frame: Three and Twelve Months
Plan to share: Yes
Supporting information: Study protocol
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Guy's and St Thomas' NHS Foundation Trust