Hearing and Structure Preservation Via ECochG

Launched by ADVANCED BIONICS AG · Feb 12, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to help people with severe to profound hearing loss by using a special technique called ECochG during cochlear implant surgery. The goal is to see if this method, which involves monitoring the cochlea (the part of the ear that helps with hearing) during the operation, provides better outcomes compared to the standard surgical approach that doesn’t use this monitoring. Researchers hope that using ECochG will lead to improved hearing and preservation of ear structures.

To participate, you need to be at least 18 years old and have severe to profound hearing loss in the ear that will be implanted. You should have had this level of hearing loss for less than 15 years and have normal ear anatomy as confirmed by imaging studies. If you join the study, you can expect to undergo standard cochlear implant surgery with the added ECochG monitoring. This study is currently recruiting participants, so if you or a loved one meet the eligibility criteria and are interested, you can consider discussing this opportunity with your healthcare provider.

Gender

ALL

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 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