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

272 Participants
are divided into 2 treatment groups

Locations

13
Birmingham
The Midlands Hearing Implant Programme (Children's Service)B4 7ET, Birmingham United Kingdom
Bradford
Yorkshire Auditory Implant ServiceBD9 6RJ, Bradford United Kingdom
Cambridge
Emmeline Centre for Hearing ImplantsCB2 0QQ, Cambridge United Kingdom
Kilmarnock
Scottish Cochlear Implant ProgrammeKA2 0BE, Kilmarnock United Kingdom

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