The aim of this study is to assess the auditory nerve functionality with an intraoperative approach following a surgical removal of acoustic neuroma in patients with severe to profound sensorineural hearing disabilities.
Whatever the acoustic neuroma treatments, the patient risks a hearing loss. The global strategy of hearing care aims to preserve the quality of life and patient hearing. For severe to profound hearing loss and anatomical auditory nerve preservation, the cochlear implant is put forward compared to the auditory brainstem implant. Indeed, cochlear implant provides better speech outcomes. If cochlear implantation is not possible or no benefit for the patient, the brainstem implant is the most widely used. The Neuristim device is used to investigate the auditory nerve integrity following neuroma surgery or on an affected auditory nerve. The Neuristim is an intra-cochlear stimulator used in an intraoperative way. The intra-cochlear electrodes provide an electrical stimulation to auditory nerve fibers, and auditory nerve response measurements to these electrical stimulation are recorded and evaluated to determine the auditory nerve functionality. The Neuristim is a device for helping surgeons to choose the most appropriate implantable solution. 2 groups of patients will be involved in this study: * a group of 17 patients with an acoustic neuroma or a past neuroma surgically removed or acoustic neuroma not requiring a surgery and with severe to profound hearing loss candidate for a cochlear implant or a auditory brainstem depending on the auditory nerve functionality, * a group of 17 patients with severe to profound hearing loss candidate for a cochlear implant.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
17
Stimulation at high, medium and low intensity on apical, medial and basal Neuristim electrode
Stimulation at high, medium and low intensity on apical, medial and basal Cochlear implant electrode
University Hospital Bordeaux - Pellegrin
Bordeaux, France
University Hospital Grenoble - A. Michallon
Grenoble, France
University Hospital Lyon - Edouard Herriot
Lyon, France
University Hospital Pitié Salpétrière
Paris, France
Wave V latency
Time frame: perioperatively
Complications
Time frame: perioperatively, 15 days postoperatively
Impedance measurement
Time frame: perioperatively
ergonomics of the Neuristim
satisfaction questionnaire
Time frame: perioperatively
Speech audiometry
in quiet and in noise
Time frame: 3 months postoperatively
Pure tone audiometry
Time frame: 3 months postoperatively
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