Hearing and Structure Preservation Via ECochG
Preservation of Hearing and Structure Using an Electrocochleography Based Corrective Action Guide
Advanced Bionics AG
102 participants
May 15, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria10
- Aged 18 years of age or older
- 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 Criteria11
- 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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Interventions
Interventional surgery with surgeon having access to intra-operative ECochG monitoring feedback to deploy ECochG based corrective action guide
Routine CI surgery with access to ECochG monitoring by surgeon
Locations(7)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06268340