Using Electrocochleography During Cochlear Implantation of the Neuro Zti. (PIC-22_eCoN)

Oticon Medical

Status: Withdrawn

Conditions: Cochlear Trauma; Cochlear Hearing Loss

Treatments: Device: Neuro Cochlear Implant System

Study type: Interventional

Funder types: Industry

Identifiers

NCT04651660

PIC-22

Details and patient eligibility

About

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.

Full 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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Manual Insertion

Experimental group

Description:

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).

Treatment:

Device: Neuro Cochlear Implant System

Robotic insertion

Experimental group

Description:

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.

Treatment:

Device: Neuro Cochlear Implant System