An Evidence Based Delivery Model of Care for Newly Implanted Adult CI Recipients
Not Applicable
Terminated
- Conditions
- Sensorineural Hearing Loss, Bilateral
- Interventions
- Other: Clinical Education and Treatment ModelOther: Traditional Model
- Registration Number
- NCT03904420
- Lead Sponsor
- Cochlear
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 4
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A - New Model Clinical Education and Treatment Model Standardized programming and testing method Group B - Traditional Model Traditional Model Traditional clinical model which is not standardized across clinical sites
- Primary Outcome Measures
Name Time Method Change in Time Spent With Audiologist 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Head and Neck Surgical Associates
🇺🇸Wichita Falls, Texas, United States
Puget Sound ENT
🇺🇸Edmonds, Washington, United States