Ireland
--:--IST
Recruiting Not applicable

Hearing and Structure Preservation Via ECochG

NCT06268340 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2024-05-15
Last updated
2026-01-06

Condition(s) studied

Hearing Loss, SensorineuralSevere-to-profound Hearing Loss

Investigational drug(s) / intervention(s)

ECochG monitored CI surgery incl. corrective action guideRoutine CI surgery without ECochG monitoring

ECochG monitored CI surgery incl. corrective action guide: Interventional surgery with surgeon having access to intra-operative ECochG monitoring feedback to deploy ECochG based corrective action guide

Routine CI surgery without ECochG monitoring: Routine CI surgery with access to ECochG monitoring by surgeon

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Hearing Preservation — From pre-operative to 6 months post-operative
    Difference in dB (absolute) and % (relative) in low-frequency hearing preservation measured via air conduction pure tone audiometry

Trial sites (7)

FacilityCityRegionStatus
Universitair Ziekenhuis Gent Ghent Gent Recruiting
Le Centre Hospitalier Régional Universitaire de Tours Tours Tours Recruiting
Universitätsklinikum Freiburg Klinik Freiburg im Breisgau Freiburg Recruiting
Ospedale Martini Torino TO Recruiting
World Hearing Center Warsaw Nadarzyn Recruiting
Hospital Universitario Clinico San Cecilio Granada Granada Recruiting
Cambridge University Hospitals NHS Foundation Trust Cambridge England Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06268340 on ClinicalTrials.gov ↗ ← All trials in Spain