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

Hearing Loss, Cochlear Clinical Trial

— NeuriStim  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02948790
• Other study ID #: PIC_05
• Status: Completed
• Phase: N/A
• Start date: April 7, 2017
• Est. completion date: April 3, 2019

Study information

• Verified date: October 2021
• Source: Oticon Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: April 3, 2019
• Est. primary completion date: April 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hearing Loss
• Hearing Loss, Cochlear
• Hearing Loss, Sensorineural
• Neurinoma of the Acoustic Nerve
• Neuroma
• Neuroma, Acoustic

Intervention

Device:
• Neuristim
Stimulation at high, medium and low intensity on apical, medial and basal Neuristim electrode
• Cochlear implant
Stimulation at high, medium and low intensity on apical, medial and basal Cochlear implant electrode

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Oticon Medical

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wave V latency		perioperatively
Secondary	Complications		perioperatively, 15 days postoperatively
Secondary	Impedance measurement		perioperatively
Secondary	ergonomics of the Neuristim	satisfaction questionnaire	perioperatively
Secondary	Speech audiometry	in quiet and in noise	3 months postoperatively
Secondary	Pure tone audiometry		3 months postoperatively

External Links

•   oticon medical website