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

Cochlear2 sites in 1 country4 target enrollmentFebruary 26, 2019

ConditionsSensorineural Hearing Loss, Bilateral

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Sensorineural Hearing Loss, Bilateral
Sponsor: Cochlear
Enrollment: 4
Locations: 2
Primary Endpoint: Change in Time Spent With Audiologist
Status: Terminated
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

February 26, 2019

End Date

October 29, 2019

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Cochlear

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in Time Spent With Audiologist

Time Frame: 6 months post activation

Change in the overall number of minutes of cochlear implant appointments over the first 6 months post activation in the new model (Group A) compared to the traditional model (Group B).