A multi-center phase III randomized control trial to evaluate effectiveness of the Both EARS (BEARS) virtual reality training package to maximize hearing abilities in children and young people with bilateral cochlear implants: the BEARS protocol

Introduction Deafness is the most common human sensory deficit. Cochlear implantation is the primary intervention for severe-to-profound deafness. Currently, over 7000 people have bilateral cochlear implants (CIs) in the United Kingdom (UK), most of whom are children. Patient feedback suggests that for children with bilateral CIs, everyday communication is challenging and tiring, with extra effort required to integrate information from two ears, especially in noise, and that current rehabilitation techniques are not engaging, or appropriate to their lifestyles. To address these issues, researchers developed the Both EARS (BEARS) training package comprised of three virtual reality games to improve sound localization and listening in noise. Objectives This protocol describes the design and methodology of a multi-center phase III randomized controlled trial (RCT) to evaluate whether use of the BEARS training package 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 children and young people (aged 8 -16 years (inclusive) with bilateral CIs. Methods This RCT is currently underway in 16 clinical CI departments in National Health Service or university hospitals across the UK. The intervention involves 3 months of spatial-listening training delivered via the BEARS training package in addition to any routine rehabilitation. The control is usual care (routine rehabilitation clinical care pathway). The primary outcome is the difference between the intervention groups in speech-in-noise perception score at 3 months derived from the spatial speech in noise (SSiN-VA) test. Recruitment closes at the end of the day on 31st July 2026, and end of data collection is 31st October 2026. Data analyses will be reported by 31st March 2026. Significance This is the largest known trial of children and young people with bilateral CIs. It will generate high-quality evidence on speech-in-noise outcomes and inform training interventions to improve spatial listening. Trial registration ClinicalTrials.gov registration: NCT05808543; UKs clinical study registry (ISRCTN92454702)