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TERMINATEDNA

An Evidence Based Delivery Model of Care for Newly Implanted Adult CI Recipients

NCT03904420•Cochlear

Summary

The clinical investigation is evaluating a new clinical model in a group of newly implanted subjects who have already been consented to CI surgery.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients who are receiving a Nucleus® CI512, CI522, or CI532 electrodes
•18 years and older
•Postlingual onset of hearing loss (onset of hearing loss \>two years of age)
•Individuals who qualify for cochlear implantation using the clinics current CI candidacy criteria
•Individuals who have recently been implanted but not yet had their external device activated
•Willingness to participate in a study and comply with all study requirements
•Fluent in spoken English

Exclusion Criteria

•Ossification or any other cochlear anomaly that might prevent insertion of less than 10 electrodes of the electrode array
•Diagnosis of retro-cochlear pathology
•Diagnosis of auditory neuropathy
•Subject considering an acoustic component in the implanted ear
•Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and use of the prosthetic device
•Unwillingness or inability to comply with all investigational requirements
•Severe-profound sensorineural hearing loss \>30 years
•Previous cochlear implant in the contralateral ear. Additional cognitive, medical or social handicaps that would prevent completion of all study requirements as determined by the investigator

Locations (2)

Head and Neck Surgical Associates

Wichita Falls, Texas, United States

Puget Sound ENT

Edmonds, Washington, United States

Key Dates

Start Date

February 26, 2019

Primary Completion Date

October 29, 2019

Completion Date

October 29, 2019

Last Updated

October 29, 2020

Enrollment

ACTUAL participants

Conditions

Sensorineural Hearing Loss, Bilateral

Interventions

Clinical Education and Treatment Model

OTHER

Traditional Model

OTHER

Auditory Performances With Different Stimulation Depths in Cochlear Implanted Subjects Using a Fine Structure Strategy

NCT04591093

Sensorineural Hearing Loss, Bilateral

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RECRUITING

Natural History in Children Up to 16 Years with Mild to Profound Hearing Loss Due to Mutations in GJB2 / OTOF Genes

NCT05402813

Sensorineural Hearing Loss, BilateralAUNB1+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 29, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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An Evidence Based Delivery Model of Care for Newly Implanted Adult CI Recipients

Inclusion Criteria

Exclusion Criteria

Auditory Performances With Different Stimulation Depths in Cochlear Implanted Subjects Using a Fine Structure Strategy

Natural History in Children Up to 16 Years with Mild to Profound Hearing Loss Due to Mutations in GJB2 / OTOF Genes

Study of Sound and Speech Perception in New Cochlear Implanted Subjects Using or Not an Anatomy-based Fitting

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