Addenbrooke's Hospital
Cambridge, CB2 OQQ, United Kingdom
NCT Number: NCT04222296
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Cambridge, CB2 OQQ, United Kingdom
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
To determine whether new hardware and fitting strategy provides better sound quality or ease of use than generic hardware and fitting methods
Time frame: 24 months
ASSE score
Cambridge University Hospitals NHS Foundation Trust
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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