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Recruiting NCT06268340

Hearing and Structure Preservation Via ECochG

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Plain-language summary for patients

Trial Parameters

Condition Hearing Loss, Sensorineural
Sponsor Advanced Bionics AG
Study Type INTERVENTIONAL
Phase N/A
Enrollment 102
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-05-15
Completion 2026-12-31
Interventions
ECochG monitored CI surgery incl. corrective action guideRoutine CI surgery without ECochG monitoring

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Brief Summary

The goal of the study is to determine the benefit of using an ECochG-based corrective action guide during cochlear implant surgery compared to the traditional surgical approach without ECochG surveillance and guidance.

Eligibility Criteria

Inclusion Criteria: * Aged 18 years of age or older * Within cochlear implant inclusion criteria by local regulations/guidelines at the time of implantation * Severe to profound hearing loss (average air conduction unaided hearing threshold of ≥ 70 dB HL for 500, 1000, 2000 and 4000 Hz) in the ear to be implanted * Air conduction unaided hearing threshold ≤ 70 dB HL at 500 Hz in the ear to be implanted * Less than 15 years of severe to profound deafness on the implant ear prior to surgery * Post-lingually acquired hearing loss in the ear to be implanted * Normal cochlear anatomy as confirmed by pre-operative imaging in the ear to be implanted * Listed for an Advanced Bionics HiRes Ultra (3D) HiFocus SlimJ electrode array * Listed for cochlear implant surgery under general anaesthesia * Fluent in local language * Given informed consent to participate in the study Exclusion Criteria: * Abnormal cochlear anatomy (including ossification) as identified by pre-operative radiological evaluati

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