Taking people in FranceNo phase
Hearing and Structure Preservation Via ECochG
Key facts
- Who runs it
- Advanced Bionics AG
- Where
- Tours, FranceSee the siteAlso in 6 other countries, 6 sites
- Trial code
- Status
- Recruiting
- People taking part
- 102 people, planned
- Started
- 15 May 2024
- Expected to end
- 31 Dec 2026
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- ECochG monitored CI surgery incl. corrective action guide
- Routine CI surgery without ECochG monitoring
- Record updated
- 6 January 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 22 criteriaShow less
Who can take part
- 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
Who cannot take part
- Any pre-existing cochlear or middle ear pathology, such as otosclerosis, cholesteatoma, or previous middle ear surgery in the ear to be implanted
- History of previous cochlear implantation/re-implantation on either ear
- Concurrent participation in other cochlear implant related studies
- 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
- Abnormal cochlear anatomy (including ossification) as identified by pre-operative radiological evaluation in the ear to be implanted
- 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)
- Any contraindications to computed tomography (CT) scans
Where in France
Also in 6 other countries, 6 sites
- Le Centre Hospitalier Régional Universitaire de ToursTours, FranceContact: David Bakhos, Prof (principal investigator)Taking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- InterventionTreatment being tested
ECochG monitored CI surgery incl. corrective action guide
Treatment: ECochG monitored CI surgery incl. corrective action guide
- ControlExisting treatment, for comparison
Routine CI surgery without ECochG monitoring
Treatment: Routine CI surgery without ECochG monitoring
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Preservation of Hearing and Structure Using an Electrocochleography Based Corrective Action Guide
- Record updated
- 6 January 2026