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Cochlear Implant clinical trials

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NCT ID: NCT03306082 Enrolling by invitation - Cochlear Implant Clinical Trials

Image-guided Cochlear Implant Programming (IGCIP)

Start date: June 23, 2015
Phase: N/A
Study type: Interventional

Cochlear implants are surgically implanted devices which restore the ability to hear to the hearing impaired. While remarkably successful, even in the best of performers restoration of hearing to levels of normal listeners is unusual. Approximately 3 weeks after surgery, cochlear implants are activated via mapping - a process in which each individual electrode (FDA approved cochlear implants have between 12 and 22 electrodes) is turned on and the stimulus level adjusted to a level that is comfortable and beneficial to the recipient. At present, this standard of care mapping procedure is performed without knowledge of the physical location between the cochlear implant electrodes and the neural interface. The research team has developed a new method of mapping using post-operative CT scans and image processing to specify the physical relationship between the cochlear implant electrodes and the neural interface allowing customized mapping. Using this information, the investigators deactivate sub-optimally positioned electrodes. The investigators term this "Image-guided Cochlear Implant Programming" (IGCIP). The study collects data in a prospective fashion for those CI recipient undergoing IGCIP.

NCT ID: NCT03304106 Completed - Cochlear Implant Clinical Trials

Clinical Investigation of New CI Delivery Models in an Adult Nucleus CI Population

Start date: October 19, 2017
Phase: N/A
Study type: Interventional

Use of Artificial Intelligent (AI) technology to assist audiologists in programming cochlear implants.

NCT ID: NCT03202797 Completed - Cochlear Implant Clinical Trials

Optimizing Regulation of a Cochlear Implant in Patients With Functional Contralateral Audition.

BIMODALITE
Start date: March 17, 2017
Phase:
Study type: Observational

360 million people in the world suffer from debilitating hearing deficiency. The cochlear implant is indicated in certain patients with severe profound deafness. The principle of the cochlear implant is to directly stimulate auditory nerve fibres by electrodes inserted in the cochlea. The steps in auditory rehabilitation are the surgical insertion of the cochlear implant, activation, and follow-up regulation. There is no formal consensus to define the exact modalities for regulation during activation or follow-up, but the principles are respected according to centres that regulate cochlear implant. Bimodal audition is the fact of having a cochlear implant and a contralateral hearing aid. In patients with cochlear implants, having binaural bimodal audition improves their auditory vocal performance in silence and in noisy environments. It needs to be considered when a second cochlear implant is not indicated for the contralateral ear. It has been shown that by allocating frequencies different from the default frequencies attributed by the manufacturer, intelligibility and perception of music are modified. The investigators therefore with to study this working hypothesis and to develop a simple protocol for the reallocation of frequencies in order to optimise auditory performance in the everyday lives of patients with implants by using an evolutionary algorithm.

NCT ID: NCT03025386 Terminated - Cochlear Implant Clinical Trials

Establish a Concordance Between the Mismatch Negativity Amplitude and a Score of Logatoms Discrimination

EVODA-ICMN
Start date: May 18, 2017
Phase: N/A
Study type: Interventional

A cochlear implant is a device for the rehabilitation of severe to profound hearing loss. Despite the standardization of surgical procedures and rehabilitation, speech discrimination performance varied significantly in cochlear implant users and could be improved by early individualized cares. However, there is no objective method yet to evaluate phonemes discrimination, especially in infants, which account for more than half of the indications for implantation. In electroencephalography (EEG), it is possible to highlight the discrimination of auditory stimuli studying the wave of MisMatch Negativity (MMN). In this work, this study propose to use the MMN as an objective vocal audiometry method to evaluate the ability to discriminate phonemes, the smallest units of oral language, in adult cochlear implant users.

NCT ID: NCT02966379 Completed - Cochlear Implant Clinical Trials

Hearing Preservation and Electro-acoustic Stimulation With EVO® Electrode Lead and Zebra® Sound Processor

Start date: March 30, 2016
Phase: N/A
Study type: Interventional

Some candidates to cochlear implantation can have residual low frequencies hearing. The EVO electrode lead has been specifically designed to preserve this residual hearing through surgery. It is then possible to provide the patient with a electro-acoustic stimulation (EAS) which combines both an acoustical stimulation for the preserved low frequency hearing and an electrical stimulation through the cochlear implant. The major aim of this study is to evaluate hearing preservation after implantation with the EVO electrode lead. The secondary outcome is to evaluate the benefit of EAS stimulation provided by the Zebra speech processor.

NCT ID: NCT02966366 Completed - Tinnitus Clinical Trials

Tinnitus Treatment With Cochlear Implant in Single Sided Deafness

Start date: August 27, 2013
Phase: N/A
Study type: Interventional

Recent studies have reported successful reduction of tinnitus after cochlear implantation (CI) in most CI users, but the mechanisms of reduction and the amount of improvement is not fully understood. Especially, the relative role of peripheral and central auditory pathways is not clearly known. This study assessed the effect of CI electrical stimulation on tinnitus in subjects with unilateral tinnitus related to a single-sided deafness (SSD), and relative contributions of peripheral and central auditory pathways in tinnitus reduction.

NCT ID: NCT02815124 Withdrawn - Cochlear Implant Clinical Trials

Trial of Image-Guided Cochlear Implant Programming Versus Standard of Care

IGCIP vs SOC
Start date: December 2021
Phase: N/A
Study type: Interventional

Cochlear implants are surgically implanted devices which restore the ability to hear to the hearing impaired. While remarkably successful, even in the best of performers restoration of hearing to levels of normal listeners is unusual. Approximately 3 weeks after surgery, cochlear implants are activated via mapping - a process in which each individual electrode (FDA approved cochlear implants have between 12 and 22 electrodes) is turned on and the stimulus level adjusted to a level that is comfortable and beneficial to the recipient. At present, this standard of care mapping procedure is performed without knowledge of the physical location between the cochlear implant electrodes and the neural interface. Our team has developed a new method of mapping using post-operative CT scans and image processing to specify the physical relationship between the cochlear implant electrodes and the neural interface allowing customized mapping. Using this information, the investigators deactivate sub-optimally positioned electrodes. The investigators term this "Image-guided Cochlear Implant Programming" (IGCIP). In a prospective fashion, the investigators have implemented IGCIP on cochlear implant recipients who have had at least 6 months of standard of care (SOC) mapping. The purpose of this study is to perform a randomized controlled trial (RCT) on newly activated cochlear implant recipients randomizing between IGCIP and SOC.

NCT ID: NCT01737489 Completed - Cochlear Implant Clinical Trials

Title: "Development and Implementation of Innovative Auditory Training Methods and Verification of These Training Methods"

Start date: October 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if aural rehabilitation adds measurable benefit and participant satisfaction to a cochlear implant recipient's overall treatment. Also, the study is designed to compare the efficacy of a commercially available aural rehabilitation program (LACE) and an electronic program which takes advantage of a traditional form of auditory training (NOOK) for cochlear implant users.

NCT ID: NCT01638052 Completed - Cochlear Implant Clinical Trials

Great Auricular Nerve Block for Children Undergoing Tympanomastoid Surgery

Start date: February 2006
Phase: Phase 2
Study type: Interventional

The investigators goal is to determine the efficacy and duration of analgesia with the addition of Clonidine, an alpha-2 agonist, to local anesthetic blockade using bupivacaine, of the great auricular nerve in children undergoing tympanomastoid surgery.