Using ECochG to improve cochlear implant surgery outcomes
Preservation of Hearing and Structure Using an Electrocochleography Based Corrective Action Guide
This study is testing whether using a special monitoring technique during cochlear implant surgery can help protect hearing better than standard surgery alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 102 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Advanced Bionics AG Industry-sponsored |
| Locations | 7 sites (Ghent, Gent and 6 other locations) |
| Trial ID | NCT06268340 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of using electrocochleography (ECochG) as a monitoring technique during cochlear implant surgery. Participants will be randomly assigned to receive either ECochG-guided surgery or standard surgery without this monitoring. The ECochG technique allows surgeons to detect potential damage to the inner ear during electrode insertion, enabling corrective actions to be taken. The study will measure participants' natural hearing before surgery and at three and six months post-implant activation to assess the impact of the intervention on hearing preservation.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with severe to profound hearing loss who meet specific cochlear implant criteria.
Not a fit: Patients with abnormal cochlear anatomy or those who do not meet the cochlear implant eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better preservation of residual hearing in patients undergoing cochlear implantation.
How similar studies have performed: While various techniques have been explored for hearing preservation during cochlear implantation, the use of ECochG in this context is a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ghent, Gent and 6 other locations
- Universitair Ziekenhuis Gent — Ghent, Gent, Belgium (Recruiting)
- Le Centre Hospitalier Régional Universitaire de Tours — Tours, Tours, France (Recruiting)
- Universitätsklinikum Freiburg Klinik — Freiburg im Breisgau, Freiburg, Germany (Recruiting)
- Ospedale Martini — Torino, To, Italy (Recruiting)
- World Hearing Center — Warsaw, Nadarzyn, Poland (Recruiting)
- Hospital Universitario Clinico San Cecilio — Granada, Granada, Spain (Recruiting)
- Cambridge University Hospitals NHS Foundation Trust — Cambridge, England, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Matt E Smith, Dr — Cambridge University Hospitals NHS Foundation Trust
- Study coordinator: Unai Martinez de Estibariz, Mr
- Email: unai.martinez@advancedbionics.com
- Phone: +34666964128
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.