Actively Recruiting
Hearing and Structure Preservation Via ECochG
Led by Advanced Bionics AG · Updated on 2026-01-06
102
Participants Needed
7
Research Sites
137 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Hearing and Structure Preservation Via ECochG
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Meet local cochlear implant criteria at time of implantation
- Severe to profound hearing loss (average unaided air conduction 70 dB HL at 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 in the ear to be implanted
- Post-lingually acquired hearing loss in the ear to be implanted
- Normal cochlear anatomy confirmed by pre-operative imaging in the ear to be implanted
- Listed for Advanced Bionics HiRes Ultra (3D) HiFocus SlimJ electrode array
- Listed for cochlear implant surgery under general anesthesia
- Fluent in local language
- Provided informed consent to participate
You will not qualify if you...
- Abnormal cochlear anatomy including ossification seen on pre-operative imaging
- Pre-existing cochlear or middle ear disease such as otosclerosis, cholesteatoma, or prior middle ear surgery in the ear to be implanted
- Medical conditions increasing risk of complications during implantation, such as autoimmune diseases or active infections
- Diagnosis of auditory spectrum neuropathy disorder
- Deafness caused by lesions of the acoustic nerve or central auditory pathway
- Deafness due to meningitis
- Single sided deafness with better ear average hearing 30 dB HL at 500, 1000, 2000, and 4000 Hz
- Asymmetric hearing loss with better ear average hearing between >30 and 55 dB HL
- Previous cochlear implantation or re-implantation on either ear
- Contraindications to CT scans
- Participation in other cochlear implant related studies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Universitair Ziekenhuis Gent
Ghent, Gent, Belgium, 9000
Actively Recruiting
2
Le Centre Hospitalier Régional Universitaire de Tours
Tours, Tours, France, 37000
Actively Recruiting
3
Universitätsklinikum Freiburg Klinik
Freiburg im Breisgau, Freiburg, Germany, 79106
Actively Recruiting
4
Ospedale Martini
Torino, TO, Italy, 10141
Actively Recruiting
5
World Hearing Center
Warsaw, Nadarzyn, Poland, 05-830
Actively Recruiting
6
Hospital Universitario Clinico San Cecilio
Granada, Granada, Spain, 18007
Actively Recruiting
7
Cambridge University Hospitals NHS Foundation Trust
Cambridge, England, United Kingdom, CB2 0QQ
Actively Recruiting
Research Team
U
Unai Martinez de Estibariz, Mr
CONTACT
M
Martina Brendel, Ms
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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