Sensorineural Hearing Loss, Bilateral
Conditions
Brief summary
To evaluate performance outcomes in patients implanted with the Cochlear Nucleus CI532 electrode array.
Detailed description
To compare speech perception and audiometric outcomes in patients implanted with the Cochlear Nucleus CI532 electrode array at 3 months postactivation with their best preoperative hearing status.
Interventions
DEVICECochlear Nucleus CI532
cochlear implantation
Sponsors
Cochlear
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Months to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Medical and audiological candidate for a CI532 cochlear implant per commercially approved, age appropriate, FDA indications * Post-linguistically deafened * Ability to complete age appropriate testing
Exclusion criteria
* Previous cochlear implantation in the ear to be implanted * Pre-linguistically deafened (onset of hearing loss at less than two years of age) * Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array * Diagnosis of retro-cochlear pathology * Diagnosis of auditory neuropathy * 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 * Additional cognitive handicaps that would prevent participation on all study requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Speech Understanding (% Correct) on AzBio Sentences in Quiet in the Implanted Ear | 3 months postactivation of the sound processor | Unilateral listening performance at 3 months post activation with the CI532 compared to the best aided unilateral preoperative condition for sentence perception in quiet. |
| Speech Understanding (% Correct) on AzBio Sentences in Noise in the Implanted Ear | 3 months post-activation | unilateral listening performance at 3 months post activation with the CI532 compared to the best aided unilateral preoperative condition for sentence perception in noise |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Implanted Subjects who meet the specified inclusion criteria and are implanted with the CI532 cochlear implant
Cochlear Nucleus CI532: cochlear implantation | 24 |
| Total | 24 |
Baseline characteristics
| Characteristic | Implanted | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 17 Participants | — |
| Age, Categorical Between 18 and 65 years | 7 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 8 Participants | — |
| Sex: Female, Male Male | 16 Participants | — |
| Speech understanding (% correct) on AzBio sentences in noise in the ear to be implanted | 5.3 percent correct STANDARD_DEVIATION 12.8 | — |
| Speech understanding (% correct) on AzBio sentences in quiet in the ear to be implanted | 11.2 percent correct STANDARD_DEVIATION 16.6 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 24 |
| other Total, other adverse events | 6 / 24 |
| serious Total, serious adverse events | 2 / 24 |
Outcome results
Primary
Speech Understanding (% Correct) on AzBio Sentences in Noise in the Implanted Ear
unilateral listening performance at 3 months post activation with the CI532 compared to the best aided unilateral preoperative condition for sentence perception in noise
Time frame: 3 months post-activation
Population: implanted and enrolled
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Implanted | Speech Understanding (% Correct) on AzBio Sentences in Noise in the Implanted Ear | 25.3 percent correct | Standard Deviation 24.5 |
Primary
Speech Understanding (% Correct) on AzBio Sentences in Quiet in the Implanted Ear
Unilateral listening performance at 3 months post activation with the CI532 compared to the best aided unilateral preoperative condition for sentence perception in quiet.
Time frame: 3 months postactivation of the sound processor
Population: implanted and enrolled
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Implanted | Speech Understanding (% Correct) on AzBio Sentences in Quiet in the Implanted Ear | 53.5 percent correct | Standard Deviation 28.2 |