Hearing Loss
Conditions
Keywords
Speech perception ability in the CI alone condition
Brief summary
To evaluate the performance of the Nucleus 5 Cochlear Implant System.
Detailed description
Performance outcomes of newly implanted adult recipients using the Nucleus 5 Cochlear Implant System.
Interventions
DEVICENucleus 5 Cochlear implant
Cochlear implant surgery
DEVICECochlear implantation
Implantation
Sponsors
Cochlear
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Eighteen years of age or older at the time of the study. * Postlinguistic onset of bilateral severe-to-profound sensorineural hearing loss * Bilateral severe-to-profound hearing loss that meets current cochlear implant criteria (\<50% open-set sentence recognition in quiet scores in the ear to be implanted and \<60% in the best-aided condition) * English spoken as the primary language. * Willingness to participate in and to comply with all requirements of the study * Subject may receive bilateral simultaneous cochlear implants.
Exclusion criteria
* Previous cochlear implant experience * Congenital hearing loss (for the purpose of this study, onset prior to 2 years-of-age). * Ossification, absence of cochlear development or any other cochlear anomaly that might prevent complete insertion of the electrode array. * Normal hearing in one or both ears. * Hearing loss of neural or central origin (e.g., deafness due to lesions on the acoustic nerve or central auditory pathway). * Active middle-ear infection. * Unwillingness and/or inability of the candidate to comply with all investigational requirements including, but not limited to, study protocol and surgical procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CNC Monosyllabic Word Performance - Treated Ear | 12 months | CNC Word Test is a validated test of open-set word recognition. The test consists of 10 lists with 50 monosyllabic words in each list. Subject responses are scored for both words and phonemes correct in the correct sequence. Subjects will be tested using a configuration of speech at 0º azimuth in quiet. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Implanted Subjects who met study inclusion and completed the primary endpoint. | 38 |
| Total | 38 |
Baseline characteristics
| Characteristic | Implanted |
|---|---|
| Age at onset of hearing loss | 40.8 years |
| Age, Continuous | 63.6 years |
| Preoperative CNC word score - Treated ear | 5.6 percent correct STANDARD_DEVIATION 1.4 |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 38 |
| serious Total, serious adverse events | 0 / 38 |
Outcome results
Primary
CNC Monosyllabic Word Performance - Treated Ear
CNC Word Test is a validated test of open-set word recognition. The test consists of 10 lists with 50 monosyllabic words in each list. Subject responses are scored for both words and phonemes correct in the correct sequence. Subjects will be tested using a configuration of speech at 0º azimuth in quiet.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Implanted | CNC Monosyllabic Word Performance - Treated Ear | 56.8 percent correct | Standard Error 3.9 |