BEARS Training Package to Maximise Hearing Abilities in Older Children and Teenagers With Bilateral Cochlear Implants (BEARS)
Hearing Loss, Sensorineural, Hearing Loss, Deafness
About this trial
This is an interventional treatment trial for Hearing Loss, Sensorineural focused on measuring Cochlear Implant, Virtual Reality, Children, Teenagers, Deaf, Bilateral, Training, Rehabilitation
Eligibility Criteria
Inclusion Criteria: Participant is a simultaneous or sequential bilateral cochlear implant user*, who either has: 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. Participant is aged 8-16 years, inclusive. Exclusion Criteria: 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. Participant is actively participating in other trials that may affect hearing outcomes or impact their ability to participate in the intervention. Participant is currently or anticipated to receive treatment and/or intervention that may affect hearing outcomes or adapt implant settings/programming. Participant is refusing to consent to trial activities/protocol. Participant is awaiting reimplantation following device failure or infection. Participant has had any changes to the programmes of either cochlear implant within the last four weeks. Participant has had a change of cochlear implant processor model or upgrade within the last four weeks. Participant is a non-user of one or both implant processors (i.e., must use both processors for a minimum of 6 hours per day over a month). Participant is a fulltime boarder at a boarding school Participant has unresolvable issues found in device checks that render one of the implants unusable. Participant is a female that is pregnant. Participant has a diagnosis of epilepsy or history of seizures of any kind.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Both EARS training package (BEARS) and Usual Care
Usual Care
BEARS is a compilation of virtual reality games designed specifically for young people with bilateral cochlear implants. The hardware is either: A Head Mounted Display Device or an iPad with headphones.
Usual care describes the routine rehabilitation received by participants via their implant centre.