Sensorineural Hearing Loss
Conditions
Keywords
Sensorineural Hearing Loss, Cochlear Implantation, Residual Hearing Preservation, Electrocochleography
Brief summary
In order to preserve the residual hearing in patients with sensorineural hearing loss (SNHL) receiving a cochlear implant (CI), the insertion trauma to the delicate and microscopic structures of the cochlea needs to be minimized. The surgical procedure starts with the conventional mastoidectomy-posterior tympanotomy (MPT) approach to the middle ear, and is followed by accessing the cochlea, with either a cochleostomy (CO) or via the round window (RW). Both techniques have their benefits and disadvantages. Another aspect is the design of the electrode array. There are fundamentally two different designs: a \*straight\* lateral wall lying electrode array (LW), or a \*pre-curved\* perimodiolar cochlear lying electrode array (PM). Interestingly, until now, the best surgical approach and type of implant is unknown. Our hypothesis is that the combination of a RW approach and a LW lying electrode array minimizes insertion trauma, leading to better hearing outcome for SNHL patients.
Interventions
PROCEDURERound window insertion
Insertion of the electrode array via the round window.
PROCEDURECochleostomy insertion
Insertion of the electrode array via cochleostomy.
DEVICELateral wall array
Lateral wall electrode array from Advanced Bionics.
DEVICEPeriomodiolar electrode array
Perimodiolar MidScala electrode array from Advanced Bionics.
Sponsors
UMC Utrecht
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Randomized controlled single-blind trial consisting of four groups: I: RW and LW, II: RW and PM, III: CO and LW and IV: CO and PM.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
* 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 | Description |
|---|---|---|
| Hearing preservation | 12 months | 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 | Description |
|---|---|---|
| Scalar position of the electrode array | 12 months | Scalar position of the electrode array (scala tympani or scala vestibuli assessed by CB-CT) |
| Electrocochleography | 12 months | ECochG (among others amplitude in µV) and eCAP (among others amplitude in µV) potentials |
| Speech perception | 12 months | Speech perception test with/without noise in CVC words correct score (in percentage) with signal to noise ratio of 10 dB. |
Countries
Netherlands
Contacts
Primary ContactImogen AML van Beurden, MD
Outcome results
None listed