Recruiting
Not applicable
Hearing and Structure Preservation Via ECochG
Condition(s) studied
Hearing Loss, SensorineuralSevere-to-profound Hearing Loss
Investigational drug(s) / intervention(s)
ECochG monitored CI surgery incl. corrective action guideRoutine CI surgery without ECochG monitoring
ECochG monitored CI surgery incl. corrective action guide: Interventional surgery with surgeon having access to intra-operative ECochG monitoring feedback to deploy ECochG based corrective action guide
Routine CI surgery without ECochG monitoring: Routine CI surgery with access to ECochG monitoring by surgeon
Study summary
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
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
Primary outcome measure(s)
- Hearing Preservation — From pre-operative to 6 months post-operative
Difference in dB (absolute) and % (relative) in low-frequency hearing preservation measured via air conduction pure tone audiometry
Trial sites (7)
| Facility | City | Region | Status |
| Universitair Ziekenhuis Gent |
Ghent |
Gent |
Recruiting |
| Le Centre Hospitalier Régional Universitaire de Tours |
Tours |
Tours |
Recruiting |
| Universitätsklinikum Freiburg Klinik |
Freiburg im Breisgau |
Freiburg |
Recruiting |
| Ospedale Martini |
Torino |
TO |
Recruiting |
| World Hearing Center |
Warsaw |
Nadarzyn |
Recruiting |
| Hospital Universitario Clinico San Cecilio |
Granada |
Granada |
Recruiting |
| Cambridge University Hospitals NHS Foundation Trust |
Cambridge |
England |
Recruiting |