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Hearing and Structure Preservation Via ECochG

This trial has no sites in United States.

It has sites in 7 countries. Choose a country to see its sites.

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Trial details

Who runs it
Advanced Bionics AG
Trial code
NCT06268340
Record updated
6 January 2026
Original description
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.Read full original descriptionShow less

Preservation of Hearing and Structure Using an Electrocochleography Based Corrective Action Guide

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.

Inclusion: 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: Any pre-existing cochlear or middle ear pathology, such as otosclerosis, cholesteatoma, or previous middle ear surgery in the ear to be implanted; History of previous cochlear implantation/re-implantation on either ear; Concurrent participation in other cochlear implant related studies; 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; Abnormal cochlear anatomy (including ossification) as identified by pre-operative radiological evaluation in the ear to be implanted; 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); Any contraindications to computed tomography (CT) scans.

ClinicalTrials.gov NCT06268340