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TERMINATEDNANCT03904420

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

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

Lead sponsor: Cochlear•2 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Cochlear

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: October 29, 2020Terms

Trial snapshot

StatusTERMINATED

PhaseNA

Enrollment4

Start dateFeb 2019

Last updatedOct 29, 2020

Condition

Sensorineural Hearing Loss, Bilateral

Locations shown

Head and Neck Surgical Associates

Wichita Falls, Texas

Puget Sound ENT

Edmonds, Washington

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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: May 10, 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.

View ClinicalTrials.gov Terms and Conditions