Deafness sensory neuronal hearing loss
Conditions
Interventions
Randomisation to one of the four groups.
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Severe hearing loss, CI candidate - 18 years of age or older - normal function of middle ear (i.e. no acute middle ear infections) - dutch language proficiency - choice for Advanced Bionics implant
Exclusion criteria
Exclusion criteria: - prior otologic surgery in the implanted ear (excluding tympanostomy tube placement) - inner ear malformation present in the ear to be implanted (i.e. ossification, Mondini malformation) - retrocochlear pathology present in the auditory system to be implanted - neurocognitive disorders - sudden deafness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hearing preservation is the main outcome, which will be expressed in percentage. Hearing preservation is calculated by using the preoperative and postoperative puretoneaudiometry (PTA). | — |
Secondary
| Measure | Time frame |
|---|---|
| Scalar position of the electrode array (scala tympani or scala vestibuli assessed by CB-CT), ECochG (among others amplitude in µV) and eCAP (among others amplitude in µV) potentials, and speech perception test with/without noise in CVC words correct score (in percentage) with signal to noise ratio of 10 dB. | — |
Countries
Netherlands
Contacts
Public ContactIAML Beurden
Universitair Medisch Centrum Utrecht
Outcome results
None listed