Integrated bimodal and CROS study
Research type
Research Study
Full title
Clinical evaluation of outcomes with hearing aid parameters designed for adults with severe-profound hearing loss and unilateral cochlear implants in bimodal (cochlear implant and contralateral hearing instrument), CROS (contralateral routing of signals) and bilateral amplification strategies.
IRAS ID
209940
Contact name
James Tysome
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
In the UK, adult cochlear implant (CI) recipients almost always receive only one implant. Despite many having some hearing in their other ear, only a minority also use a hearing aid (HA) for what is known as bimodal listening. This study will investigate whether a HA specifically designed and fitted to work with the CI can bring benefits beyond those provided by a generic HA.
The study will involve three groups. This first is experienced adult bimodal users of the AB system who have usable contralateral residual hearing. A clinical baseline and three research conditions will be evaluated. The Naida CI Link HA (Link) will be fitted, tested and then optimised using a special bimodal fitting formula. Subjects will be allowed three months to acclimatize and will then be retested. A second intervention will involve modifying the CI settings to minimize the mis-match between frequencies delivered via the CI. The third research condition will evaluate the fully integrated bimodal system, where the microphone signals from CI and HA are shared and a bilateral beamformer is formed.
A second group with no aidable hearing on their non-implanted ear will also be studied. A contralateral routing of signal (CROS) device will sense sounds on the non-implanted side. Tests will be made with and without CROS. The bimodal group will also be tested with CROS. Conditions without and with CROS and with a beamformer as described above will be tested.
Finally as a control group, bilateral HA users will be tested with the similar HA fitting as used for the bimodal group. This will enable a comparison of standard fitting protocols against the new rationale using the same devices.
Devices used for patients in groups 1+2 are available in standard of care, Group 3 must return the device following the trial.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
18/EE/0160
Date of REC Opinion
27 Jul 2018
REC opinion
Further Information Favourable Opinion