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Clinical Trials/NCT02948790
NCT02948790
Completed
N/A

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

Oticon Medical4 sites in 1 country17 target enrollmentApril 7, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hearing Loss, Cochlear
Sponsor
Oticon Medical
Enrollment
17
Locations
4
Primary Endpoint
Wave V latency
Status
Completed
Last Updated
4 years ago

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.

Registry
clinicaltrials.gov
Start Date
April 7, 2017
End Date
April 3, 2019
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Wave V latency

Time Frame: perioperatively

Secondary Outcomes

  • Complications(perioperatively, 15 days postoperatively)
  • Impedance measurement(perioperatively)
  • ergonomics of the Neuristim(perioperatively)
  • Speech audiometry(3 months postoperatively)
  • Pure tone audiometry(3 months postoperatively)

Study Sites (4)

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