Both EARS training package (BEARS) to maximise hearing abilities in older children and teenage bilateral cochlear implant users

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.