NCT04222296

Bimodal, CROS and Severe Profound Hearing Loss Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Cambridge University Hospitals NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The study will involve the comparison of three groups with severe-profound hearing loss. Patients with a Cochlear Implant only, patients with a cochlear implant and Hearing Aid, and finally patients with two hearing aids. This will enable a comparison of standard fitting protocols against the new rationale using the same devices. Devices used for patients in all 3 groups are now available in standard of care, and can be kept afterwards should the patients wish.

Detailed description

The study will involve three groups of 20 patients per group. 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. The second 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 third intervention will involve modifying the CI settings to minimize the mis-match between frequencies delivered via the CI. A second group with no aidable hearing on their non-implanted ear will also be studied. A contralateral routing of signal (CROS) device will send sounds on the non-implanted side. Tests will be made with and without CROS, as well as with directional microphone settings. 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.

Conditions

• Cochlear Implant
• Severe-Profound Hearing Loss
• Hearing Loss, Bilateral
• Hearing Loss, Cochlear

Interventions

Type	Name	Description
DEVICE	Fitting strategy of cohlear implant of hearing aid	To determine whether new hardware and fitting strategy provides better sound quality or ease of use than generic hardware and fitting methods

Timeline

• Start date: 2018-09-04
• Primary completion: 2021-03-01
• Completion: 2021-03-01
• First posted: 2020-01-09
• Last updated: 2021-07-02

Locations

1 site across 1 country: United Kingdom