Hearing and Structure Preservation Via ECochG
Recruiting now · Not applicable
Conditions studied: Hearing Loss, Sensorineural, Severe-to-profound Hearing Loss
In brief
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.
Key facts
- Study ID
- NCT06268340
- Run by
- Advanced Bionics AG
- People needed
- 102
- Starts
- 2024-05-15
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-01-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Universitair Ziekenhuis Gent — Ghent, Gent, Belgium (enrolling)
- Le Centre Hospitalier Régional Universitaire de Tours — Tours, Tours, France (enrolling)
- Universitätsklinikum Freiburg Klinik — Freiburg im Breisgau, Freiburg, Germany (enrolling)
- Ospedale Martini — Torino, TO, Italy (enrolling)
- World Hearing Center — Warsaw, Nadarzyn, Poland (enrolling)
- Hospital Universitario Clinico San Cecilio — Granada, Granada, Spain (enrolling)
- Cambridge University Hospitals NHS Foundation Trust — Cambridge, England, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
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