Sensorineural Hearing Loss, Bilateral
Conditions
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.
Interventions
OTHERClinical Education and Treatment Model
Patients will have self directed equipment education and standardized programming approaches
OTHERTraditional Model
Standard clinical practice and education
Sponsors
Cochlear
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group A - New Model Standardized programming and testing method
Clinical Education and Treatment Model: Patients will have self directed equipment education and standardized programming approaches | 2 |
| Group B - Traditional Model Traditional clinical model which is not standardized across clinical sites
Traditional Model: Standard clinical practice and education | 2 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study terminated | 2 | 2 |
Baseline characteristics
| Characteristic | Group B - Traditional Model | Total | Group A - New Model |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 2 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 2 Participants | 1 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 2 participants | 4 participants | 2 participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 0 Participants |
| Sex: Female, Male Male | 0 Participants | 2 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 2 |
| other Total, other adverse events | 0 / 2 | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 | 0 / 2 |
Outcome results
Primary
Change in Time Spent With Audiologist
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).
Time frame: 6 months post activation
Population: No subjects completed all required visits and data for primary endpoints were not collected due to study termination shortly after execution commenced.