Using ECochG to improve cochlear implant surgery outcomes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Using robotics and electrocochleography for cochlear implant surgery

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• Understanding listening effort in cochlear implant users

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• Comparing experiences of over-the-counter and audiologist-fitted hearing aids

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  Recruiting at 2 sites University of Iowa · Iowa City, Iowa and 1 other locations · NCT06499805

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.