Using Electrocochleography During Cochlear Implantation of the Neuro Zti.

NCT ID: NCT04651660

Last Updated: 2023-03-31

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-31
• Study Completion Date: 2024-01-31

Brief Summary

The main objective of this study is to evaluate the correspondence between eCochG and residual hearing by adding two modifications. First, a novel technique for placing and maintaining the probe in place during the whole insertion will be used. Second, a new metric for estimating the eCochG response will be evaluated (eCochG trauma index). The secondary objective is to find other markers of the cochlear trauma insertion associated to eCochG measures. This will be used to evaluate to which extend a traumatic insertion will be deleterious for the patient's post-operative hearing, and ultimately to prevent trauma to the inner ear. Finally, the potential differences in cochlear trauma resulting of the electrode array insertion from two different surgery techniques will be investigated; Either using a manual insertion or using a robotic arm that will drive the insertion automatically.

Detailed Description

Main study procedures and assessments:

• Visit 1 (D-30+/-14) INCLUSION: subject information/consent, inclusion/exclusion criteria, CT-scan, Tonal audiometry
• Visit 2 (D0+/-14) COCHLEAR IMPLANT SURGERY: CT-scan, Intra-op eCochG, eCAP, Impedance
• Visit 3 (D+30+/-14) FOLLOW-UP 1 MONTH: Tonal audiometry, Impedance, Fitting maps
• Visit 4 (D+60+/-14) FOLLOW-UP 2 MONTH: Tonal audiometry, Impedance, Fitting maps, Phonemes
• Visit 5 (D+90+/-14) FOLLOW-UP 3 MONTH: Tonal audiometry, Impedance, Fitting maps, Phonemes

Conditions

Cochlear Hearing Loss; Cochlear Trauma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Manual Insertion

The surgeon will follow a classical surgical procedure for the cochlear implantation, i.e. mastoidectomy to access the temporal bone, posterior tympanotomy to access the cochlea and round window (RW) approach for the CI electrode array insertion. Before opening the RW, the eCochG recording electrode is placed on the cochlear promontory, and placed not to obstruct the surgery. The probe is thus maintained during the whole MANUAL insertion (by the surgeon).

Group Type: EXPERIMENTAL

Neuro Cochlear Implant System

Intervention Type: DEVICE

Before the mastoidectomy, the ear canal is cleaned, the insert earphone is connected to the Eclipse (Oticon Medical software) preamplifier and placed into the ear canal. The EEG scalp electrodes (active, ground electrode) are placed on the patient's head. After the posterior tympanotomy, the reference electrode (eCochG probe) is placed on the cochlear promontory.

The CI electrode array will be inserted following one of the two possible techniques while the eCochG will be recording. The surgeon will either manually insert the array using the Oticon Medical stylet and following the surgery guides and recommendations from Oticon Medical or will control the Robotol insertion angle and drive the robotic arm in the same way.

Robotic insertion

The surgeon will follow a classical surgical procedure for the cochlear implantation, i.e. mastoidectomy to access the temporal bone, posterior tympanotomy to access the cochlea and round window (RW) approach for the CI electrode array insertion. Before opening the RW, the eCochG recording electrode is placed on the cochlear promontory, and placed not to obstruct the surgery. The probe is thus maintained during the whole ROBOTIC insertion.

Group Type: EXPERIMENTAL

Neuro Cochlear Implant System

Intervention Type: DEVICE

Before the mastoidectomy, the ear canal is cleaned, the insert earphone is connected to the Eclipse (Oticon Medical software) preamplifier and placed into the ear canal. The EEG scalp electrodes (active, ground electrode) are placed on the patient's head. After the posterior tympanotomy, the reference electrode (eCochG probe) is placed on the cochlear promontory.

The CI electrode array will be inserted following one of the two possible techniques while the eCochG will be recording. The surgeon will either manually insert the array using the Oticon Medical stylet and following the surgery guides and recommendations from Oticon Medical or will control the Robotol insertion angle and drive the robotic arm in the same way.

Interventions

Neuro Cochlear Implant System

Before the mastoidectomy, the ear canal is cleaned, the insert earphone is connected to the Eclipse (Oticon Medical software) preamplifier and placed into the ear canal. The EEG scalp electrodes (active, ground electrode) are placed on the patient's head. After the posterior tympanotomy, the reference electrode (eCochG probe) is placed on the cochlear promontory.

The CI electrode array will be inserted following one of the two possible techniques while the eCochG will be recording. The surgeon will either manually insert the array using the Oticon Medical stylet and following the surgery guides and recommendations from Oticon Medical or will control the Robotol insertion angle and drive the robotic arm in the same way.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• > or equal 18 years ;
• Candidate for Neuro Zti EVO cochlear implant system, unilateral or bilateral recipient ;
• Preoperative residual hearing with audiometric thresholds less or equal than 80 dB at 500 Hz, or higher frequencies

Exclusion Criteria

• Medical or psychological conditions which contraindicate surgery (e.g middle ear infection, tympanic membrane perforation) ;
• Patient with a psychological or linguistic inability to understand the information sheet ;
• Patient under legal protection or deprived of liberty
• Patient included and participating to another trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oticon Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yann YN Nguyen

Role: PRINCIPAL_INVESTIGATOR

Hôpital Pitié-Salpêtrière (Paris)

Other Identifiers

PIC-22

Identifier Type: -

Identifier Source: org_study_id