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Taking people in ItalyNo phase

Hearing and Structure Preservation Via ECochG

Key facts

Who runs it
Advanced Bionics AG
Where
Torino, ItalySee 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 Italy

Also in 6 other countries, 6 sites

  • Ospedale MartiniTorino, ItalyContact: Diego Di Lisi, Dr (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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data 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