NCT02948790

Auditory Nerve Monitoring Using Intra-cochlear Stimulation in Subjects With Acoustic Neuroma

Auditory Nerve Monitoring Using Intra-cochlear Stimulation in Subjects With Acoustic Neuroma : Feasibility Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Oticon Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hearing Loss, Cochlear
• Neurinoma of the Acoustic Nerve

Interventions

Type	Name	Description
DEVICE	Neuristim	Stimulation at high, medium and low intensity on apical, medial and basal Neuristim electrode
DEVICE	Cochlear implant	Stimulation at high, medium and low intensity on apical, medial and basal Cochlear implant electrode

Timeline

• Start date: 2017-04-07
• Primary completion: 2019-04-03
• Completion: 2019-04-03
• First posted: 2016-10-28
• Last updated: 2021-10-20

Locations

4 sites across 1 country: France