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Hearing and Structure Preservation Via ECochG

RecruitingNAAges 18 Years - anyAllAdvanced Bionics AG
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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 evaluation in the ear to be implanted * Any pre-existing cochlear or middle ear pathology, such as otosclerosis, cholesteatoma, or previous middle ear surgery in the ear to be implanted * Any medical conditions that would increase the risk of local complications during cochlear implantation, such as autoimmune diseases or active local infections * Diagnosis of auditory spectrum neuropathy disorder * Deafness due to lesions of the acoustic nerve or central auditory pathway * Deafened by meningitis * Single sided deafness (average for 500, 1000, 2000 and 4000 Hz in the better ear ≤ 30 dB HL) * Asymmetric hearing loss (average for 500, 1000, 2000 and 4000 Hz in the better ear \> 30 dB HL and ≤ 55 dB HL) * History of previous cochlear implantation/re-implantation on either ear * Any contraindications to computed tomography (CT) scans * Concurrent participation in other cochlear implant related studies
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What it tests

  • ECochG monitored CI surgery incl. corrective action guide
  • Routine CI surgery without ECochG monitoring
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Where

7 sites
Universitair Ziekenhuis Gent
Ghent, Belgium
Le Centre Hospitalier Régional Universitaire de Tours
Tours, France
Universitätsklinikum Freiburg Klinik
Freiburg im Breisgau, Germany
Ospedale Martini
Torino, Italy
World Hearing Center
Warsaw, Poland
Hospital Universitario Clinico San Cecilio
Granada, Spain
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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