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

Oticon Medical

Status: Completed

Conditions: Neurinoma of the Acoustic Nerve; Hearing Loss, Cochlear

Treatments: Device: Neuristim; Device: Cochlear implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT02948790

PIC_05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must be 18 years or older
• Patient with an acoustic neuroma already surgically removed with associated hearing loss (experimental group),
• Patient with an acoustic neuroma programmed to be surgically removed and candidates for an implantable hearing rehabilitation solution (experimental group),
• Patient with an acoustic neuroma that not need to be removed and candidate for an implantable hearing rehabilitation solution (experimental group), or
• Typical patient candidate for a cochlear implant (control group)

Exclusion criteria

• Cochlea malformation, cochlea ossification
• Vulnerable subject

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 2 patient groups

Neuristim

Experimental group

Description:

Electrical stimulation with the Neuristim and auditory nerve electrical response measurements (wave V).

Treatment:

Device: Neuristim

Digisonic SP EVO cochlear implant

Active Comparator group

Description:

Electrical stimulation with the patient's cochlear implant and auditory nerve electrical response measurements (wave V).

Treatment:

Device: Cochlear implant