Health Trials

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • ECochG monitored CI surgery incl. corrective action guide
  • Routine CI surgery without ECochG monitoring

Treatment groups

102 Participants
are divided into 2 treatment groups

Locations

7
Belgium
Universitair Ziekenhuis Gent9000, GhentGent, Belgium
France
Le Centre Hospitalier Régional Universitaire de Tours37000, ToursTours, France
Germany
Universitätsklinikum Freiburg Klinik79106, Freiburg im BreisgauFreiburg, Germany
Italy
Ospedale Martini10141, TorinoTO, Italy

Sponsors and collaborators

Advanced Bionics AG

Lead sponsor

Source ClinicalTrials.gov