Hearing and Structure Preservation Via ECochG (NCT06268340) | Clinical Trial Compass
RecruitingNot Applicable
Hearing and Structure Preservation Via ECochG
Belgium, France, Germany102 participantsStarted 2024-05-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* S…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Hearing Preservation
Timeframe: From pre-operative to 6 months post-operative