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.
Eligibility criteria
Qualifiers
Congenital severe/profound bilateral sensorineural hearing loss and have received at least one implant ≤ 36 months of age.
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)
Participant has stable programmes (defined as no longer using progressive programmes to work through).
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.
Disqualifiers
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 intervention or assessment questions.
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.
Trial design
Treatments tested in this trial
- Both EARS training package (BEARS)
- Usual Care
Treatment groups
Sponsors and collaborators
Guy's and St Thomas' NHS Foundation Trust
Lead sponsor
University of Cambridge
Collaborator
University College, London
Collaborator
Imperial College London
Collaborator
University of Nottingham
Collaborator
Cambridge University Hospitals NHS Foundation Trust
Collaborator
University of Southampton
Collaborator
National Institute for Health Research, United Kingdom
Collaborator