NCT05808543 BEARS Training Package to Maximise Hearing Abilities in Older Children and Teenagers With Bilateral Cochlear Implants

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 272 participants in total. It began in 2023-07-27 with a primary completion date of 2026-10-31.

Brief Summary

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

Inclusion Criteria: 1. Participant is a simultaneous or sequential bilateral cochlear implant user\*, who either has: 1. Congenital severe/profound bilateral sensorineural hearing loss and have received at least one implant ≤ 36 months of age. 2. 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) 2. Participant has stable programmes (defined as no longer using progressive programmes to work through). 3. 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. 4. Participant is aged 8-16 years, inclusive. Exclusion Criteria: 1. Participant (or parent/legal representative) does not speak/understand English sufficiently to undertake assessments. 2. Participant has an intellectual disability at a level that would prevent their ability to understand the trial the intervention or assessment questions. 3. Participant has a comorbid condition impacting ability to participate in the intervention and/or outcome assessment. 4. Participant has an audiological profile impacting ability to participate in the intervention and/or outcome assessments. 5. Participant is actively participating in other trials that may affect hearing outcomes or impact their ability to participate in the intervention. 6. Participant is currently or anticipated to receive treatment and/or intervention that may affect hearing outcomes or adapt implant settings/programming. 7. Participant is refusing to consent to trial activities/protocol. 8. Participant is awaiting reimplantation following device failure or infection. 9. 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). 10. Participant is a fulltime boarder at a boarding school 11. Participant has unresolvable issues found in device checks that render one of the implants unusable. 12. Participant is a female that is pregnant. 13. Participant has a diagnosis of epilepsy or history of seizures of any kind.

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