An Evidence Based Delivery Model of Care for Newly Implanted Adult CI Recipients
Stopped early · Not applicable
Conditions studied: Sensorineural Hearing Loss, Bilateral
In brief
The clinical investigation is evaluating a new clinical model in a group of newly implanted subjects who have already been consented to CI surgery.
Key facts
- Study ID
- NCT03904420
- Run by
- Cochlear
- People needed
- 4
- Starts
- 2019-02-26
- Expected to finish
- 2019-10-29
- Last updated by the study team
- 2020-10-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Head and Neck Surgical Associates — Wichita Falls, Texas, United States
- Puget Sound ENT — Edmonds, Washington, United States
Full record on ClinicalTrials.gov
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