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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Hearing Loss, Cochlear, Neurinoma of the Acoustic Nerve

Intervention / Treatment
-----------------
* Device: Neuristim
* Device: Cochlear implant


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neuristim<br>Electrical stimulation with the Neuristim and auditory nerve electrical response measurements (wave V). | Device: Neuristim<br>* Stimulation at high, medium and low intensity on apical, medial and basal Neuristim electrode<br>|
| Active Comparator: Digisonic SP EVO cochlear implant<br>Electrical stimulation with the patient's cochlear implant and auditory nerve electrical response measurements (wave V). | Device: Cochlear implant<br>* Stimulation at high, medium and low intensity on apical, medial and basal Cochlear implant electrode<br>* Other names: Digisonic SP EVO;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wave V latency |  | perioperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications |  | perioperatively, 15 days postoperatively | 
| Impedance measurement |  | perioperatively | 
| ergonomics of the Neuristim | satisfaction questionnaire | perioperatively | 
| Speech audiometry | in quiet and in noise | 3 months postoperatively | 
| Pure tone audiometry |  | 3 months postoperatively |