Home › Trials › NCT05808543

BEARS directional-listening training to improve hearing in older children and teens with two cochlear implants

A Randomised Controlled Trial to Evaluate the Effectiveness of Spatial-listening Training Delivered Via the Both EARS Training Package (BEARS) in Older Children and Teenagers With Bilateral Cochlear Implants

Not applicable Interventional Guy's and St Thomas' NHS Foundation Trust · NCT05808543

This trial tests whether 3 months of the BEARS virtual-reality directional listening training, added to usual care, helps 8–16 year olds with two cochlear implants hear better in noisy places, reduce listening effort, and improve vocabulary and quality of life.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment272 (estimated)
Ages8 Years to 16 Years
SexAll
SponsorGuy's and St Thomas' NHS Foundation Trust Academic / other
Locations13 sites (Birmingham, Birmingham and 12 other locations)
Trial IDNCT05808543 on ClinicalTrials.gov

What this trial studies

The trial randomizes 8–16 year olds who use two cochlear implants to either 3 months of BEARS virtual-reality directional listening training plus usual care or to usual care alone. BEARS consists of game-like VR exercises that train sound localisation and listening in noise. Participants complete baseline hearing tests and questionnaires, then the 3-month intervention, followed by online and in-person follow-up visits over the next 9 months. The study is conducted at NHS and university cochlear implant centres in the UK with regular clinical oversight.

Who should consider this trial

Good fit: Ideal candidates are 8–16 year olds who use two cochlear implants (both processors for at least 6 hours per day), have stable device programming and recent clinic checks, and can engage with virtual-reality game training.

Not a fit: Children with only one implant, those who do not use both processors regularly, those with unstable or progressive device maps, or who cannot use VR equipment or understand the study materials are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, BEARS could improve speech-in-noise understanding, reduce listening effort, and boost vocabulary and quality of life for young bilateral cochlear implant users.

How similar studies have performed: Some auditory training programs have shown modest gains in speech-in-noise for cochlear implant users, but VR directional-listening training for bilateral pediatric CI users is relatively novel and not yet widely tested in randomized trials.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Birmingham, Birmingham and 12 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hearing Loss, SensorineuralHearing LossDeafnessHearing Impaired Children and AdolescentsCochlear ImplantVirtual RealityChildrenTeenagers
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.