Title: Both EARS training package (BEARS) to maximise hearing abilities in older children and teenage bilateral cochlear implant users
Funder: Department of Health and Social Care

Abstract: Background Older children and teenagers with bilateral cochlear implants do not fulfil their potential due to poor sound localisation abilities and degraded speech-in-noise perception. These deficits jeopardise speech and language development, education, and social well-being. The lack of protocols for fitting bilateral cochlear implants, ecologically-valid outcome measures, and resources for spatial-hearing training, contribute to these listening difficulties. Spatial hearing abilities develop over time with bilateral experience. A large body of research demonstrates that sound localisation can improve with training, underpinned by plasticity-driven changes in the auditory pathways for children and adults. We have developed a package of Virtual-Reality games (BEARS, Both EARS) to train spatial hearing in older children and teenagers with bilateral implants. This Programme is to evaluate this package. Aim To determine whether the use of BEARS leads to improvements in everyday hearing for older children and teenagers with bilateral cochlear implants. Objectives To determine whether the use of BEARS: (i) improves speech-in-noise perception in spatial environments; (ii) improves quality of life; (iii) is cost effective; (iv) improves perceived benefits of everyday listening. Methods During the development phase (years 1 and 2), we will optimise BEARS using participatory design methods with a Patient and Public Involvement Group as co-creators. Another group will inform the content of a qualitative topic guide for the clinical trial and define the Normalisation Process Theory elements for use in a Process Evaluation and for Scaling Up BEARS for mainstream use in the NHS. A clinician group will manualise the Usual Care Pathway. Additionally, the age-appropriate normal-hearing range will be determined for the spatial speech-in-noise measures. An existing bilateral hearing-specific quality of life measure and a tool for capturing healthcare resource usage will be adapted for older children and teenagers with bilateral implants for use in the clinical trial. In the trial phase (years 3, 4 and 5), we will recruit 384 children (8-16 years) with bilateral implants from 9 clinics. They will be randomly allocated to one of two groups: BEARS or Usual Care. The BEARS group will receive 3 months of spatial-listening training. Both groups will attend clinics for assessments at baseline, 3 and 12 months. Qualitative interviews will occur following the trial. Outcomes include spatial speech-in-noise measures, quality of life, resource use and perceived benefits. Assessors will be blind to group allocation. A Process Evaluation will evaluate the trial quality and the intervention engagement. A cost-utility analysis using trial data will be performed. Timeline for delivering Outputs and deliverables will be made immediately available to clinicians. We will communicate findings to the public through organised events supported by patient groups and charities. It should take 12 to 18 months for full awareness. Anticipated impact and dissemination Positive outcomes will lead to readily available computer-based portable training tools for older children and teenagers with bilateral implants. It would transform current practice from outpatient-based rehabilitation to self-administered training. Tailored objective and subjective outcome measures can replace current utilities, to better evaluate everyday hearing experiences.

Lay abstract: Background Cochlear implants are medical devices implanted in the ears. They send electricity to the hearing nerve, allowing people with significant deafness to hear. Deaf children can have an operation to put cochlear implants in both ears. The brain learns to make sense of the sound from the implants. Two implants provide better access to sound but it can be challenging to interpret what is heard from both sides. Children with normal hearing can separate and locate sounds (localisation) which is vital for understanding speech in noisy places. For children with two cochlear implants they find this difficult because: Cochlear implants cannot play all sounds Their two implants are set up separately and not as one hearing system There is no specific training to make the most of having two implants We spoke with a group of older children and teenagers with two implants, who told us that: It is hard to balance sounds from two implants. Assessments and rehabilitation in clinics do not reflect real life. They prefer to use technology to support their learning. To address these concerns, we have developed BEARS (Both EARS), a virtual-reality computer game with a series of difficulty levels. BEARS trains sound localisation using speech and music. We also designed a speech test that better reflects everyday listening. Aims of the Study We will determine whether BEARS leads to better hearing in noisy places for older children and teenagers with two cochlear implants. Study Design Initially, we will make BEARS even more engaging. We will determine the range of scores expected on our speech test by older children and teenagers with normal hearing, to help understand how older children and teenagers with cochlear implants compare to normal-hearing peers. With help from cochlear-implanted older children and teenagers we will re-design a questionnaire about life quality to measure the benefit of BEARS. Secondly, we will assess BEARS in a clinical trial with 384 older children and teenagers with two implants from nine UK clinics. Half will use BEARS and half routine rehabilitation. After 12 months we will measure whether BEARS is helpful by comparing speech and questionnaire scores from each group. We will interview participants to understand how BEARS affected their daily hearing and ask about ways to make BEARS easy to use in everyday life. Patient Public Involvement We will involve groups of older children and teenagers with two implants to help with: Improving BEARS Designing study website Re-wording our questionnaire to be child friendly Study Completion An important part of our research is to develop a plan with clinicians and patients for using BEARS in clinical practice. After the study, BEARS will be freely available through the website together with clear user guides.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: EAR