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Cochlear Implant clinical trials

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NCT ID: NCT06142682 Not yet recruiting - Cochlear Implant Clinical Trials

Dexamethasone Eluting Cochlear Implant: a Pivotal Study

CDEX2
Start date: June 30, 2024
Phase: N/A
Study type: Interventional

The newly developed MED-EL Cochlear Implant Mi1250 +FLEX28 DEX (CIDEXEL) incorporates the anti-inflammatory agent dexamethasone (DEX) into the electrode array. The passive elution of DEX during the post-implantation period has the purpose of counteracting the increase of the post-operative impedance induced by the insertion trauma. The aim of this clinical investigation is to obtain confirmatory data concerning safety and performances of the investigational device in the clinical population.

NCT ID: NCT06086041 Recruiting - Clinical trials for Magnetic Resonance Imaging

Predictive Study on Hearing Rehabilitation After Cochlear Implant

Start date: January 17, 2022
Phase:
Study type: Observational

The aim of this study is to display the predictive factors of hearing rehabilitation after cochlear implant surgery in severely to profoundly deaf adults.

NCT ID: NCT05923203 Recruiting - Hearing Loss Clinical Trials

Combined Electric and Acoustic Hearing (EAS) in Children and Adults

Start date: December 5, 2022
Phase: N/A
Study type: Interventional

Cochlear implants are surgically implanted devices which restore the ability to hear to the hearing impaired. Improvements in surgery and electrodes have results in an increased number of adults and children who have residual hearing and can benefit from electric and acoustic hearing in the same ear. This is called Electric Acoustic Stimulation (EAS). Many studies have shown that adult EAS users show significant benefits for speech understanding in noise and spatial hearing tasks as compared to a CI paired only with a contralateral HA. Even though this type of hearing is becoming more common, there is limited research on how it can be beneficial to children with CIs. The benefits of this study are a greater understanding of the participant's speech understanding, binaural processing, and spatial hearing. The results will help audiologists and researcher better understand how cochlear implants work, specifically when using electric and acoustic hearing in the same ear.

NCT ID: NCT05360212 Recruiting - Quality of Life Clinical Trials

Anatomy-based Fitting in Cochear Implant Users

Start date: March 11, 2022
Phase: N/A
Study type: Interventional

In this study, the performance with the CI is investigated over time in three groups of freshly implanted CI users. Both the standard frequency-band distribution and anatomy-based fitting will be used to compare outcomes.

NCT ID: NCT05319678 Recruiting - Music Clinical Trials

Analysis of Musical and Voice Skills in Children and Adult Cochlear Implant Users

Start date: February 10, 2022
Phase:
Study type: Observational [Patient Registry]

Aims: To evaluate the perception and enjoyment of music in cochlear implant (CI) users using specific questionnaires, and comparing their results with a control group of subjects with normal hearing (NH). To analyze the musical abilities of implantees using the musical tool Meludia, and compare the results with the control group. To perfom a voice analysis in implanted patients, compare it with their NH peers, and check if an association with musical perception is observed. Design: Cross-sectional study, both the CI recipients and NH control subjects were assessed once. Setting and subjects: Pre-or perilingual patients aged 6 to 17 years old, and postlingual adults who underwent cochlear implantation from 2000 to January 2023 at La Paz University Hospital. Control group is set up with their NH peers. Study Variables: Socio-demographic and clinical (current age, age at implantation, sex, educational level) variables will be collected, as well as hearing loss (aetiology, duration of deafness), and surgical (type of implant, complete or partial insertion of the electrodes, date of surgery) data. Data from CI fitting (number of active electrodes, type of audio processor) and hearing outcomes with the CI will also be reviewed. Outcome variables: Specific musical skills questionnaires for adults: Munich Music Questionnaire (MuMu) and Music Related Quality of Life Questionnaire (MuRQoL), which will be validated. Musical questionnaire developed specifically for subjects between 6-17 years old. Musical tool (Meludia) to assess musical perception. Praat software for voice analysis. Analysis of the impact of the different audiological, sociodemographic and clinical variables on hearing outcomes, and on musical perception after cochlear implantation, and comparison with the NH control group.

NCT ID: NCT05275712 Not yet recruiting - Cochlear Implant Clinical Trials

Outcome of Cochlear Implant in Assiut University

Start date: March 2023
Phase:
Study type: Observational

Evaluation of the outcome of cochlear implanted children at audiovestibular medicine unit in Assiut university hospital.

NCT ID: NCT05079867 Recruiting - Hearing Loss Clinical Trials

Cochlear Trauma, Functional and Structural Preservation in Cochlear Implant Surgery

Start date: July 19, 2021
Phase:
Study type: Observational

Prospective 2-arm cohort consisting of a preoperative visit and visits at the time of implantation (Day 0) and follow-up in patients for whom their treating physician indicated a perimodiolar or straight cochlear implant.

NCT ID: NCT04722042 Active, not recruiting - Cochlear Implant Clinical Trials

Place-based Mapping in EAS Listeners

Start date: February 23, 2021
Phase: N/A
Study type: Interventional

Purpose: Investigate monaural and binaural hearing in electric-acoustic stimulation (EAS) users with place-based versus default maps. Participants: Cochlear implant recipients and normal-hearing listeners Procedures (methods): This is a prospective, longitudinal investigation of the monaural and binaural outcomes (such as speech perception, spatial hearing, and/or subjective benefit) of cochlear implant recipients listening with different programs. The programs will incorporate different patient and device variables to determine the effect on cochlear implant recipient outcomes.

NCT ID: NCT04711538 Recruiting - Cochlear Implant Clinical Trials

Role of Diagnostic Imaging in Cochlear Implant

Start date: February 2021
Phase:
Study type: Observational

cochlear implant is a well accepted treatment to profound sensorineural hearing loss. Imaging provides essential information about anatomical Variants that could be riskyand should be considered by cochlear implant surgeon and the aim of the study:- - Identify inner ear congenital and acquired abnormalities. - Identify cochlear nerve anomalies. - Detect temporal bone abnormalities that require surgical modification by cochlear implant surgeon.

NCT ID: NCT04577118 Completed - Cochlear Implant Clinical Trials

The iotaSOFT Insertion System Safety Study

Start date: September 18, 2020
Phase: N/A
Study type: Interventional

Non-significant risk evaluation of the iotaSOFT Insertion System when used by a surgeon to assist with inserting a cochlear implant electrode array.