Hearing Loss
Conditions
Brief summary
This study is to evaluate new approaches to device fitting and diagnostics for cochlear implant users. The evaluation can be performed in the laboratory in an acute session or in real world environments with take-home device use to further validate their benefits. Each feature will be tested in a sub-study specific to that hearing care model. On average, each sub-study is expected to include approximately 20 subjects.
Interventions
DEVICECochlear Implant and sound processor device fitting paradigm or diagnostic/measurement technique
The investigational device will be a new device fitting paradigm or diagnostic/measurement technique implemented for use with the commercially available sound processor and implant.
Sponsors
Cochlear
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Masking description
Participants were masked to which fitting method they had at any point in the study
Intervention model description
Interrupted time series
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Users of a CE approved Nucleus cochlear implant, resulting in open set speech understanding * At least three months of experience with the cochlear implant. * Older than 18 years when entering the study. * Subject is fluent speaker in the language used for assessments. * Open set speech understanding sufficient to complete the study protocol as judged by the investigator. * Willing and able to provide written informed consent
Exclusion criteria
* Unable or unwilling to comply with the requirements of the clinical investigation as determined by the investigator. * Additional health factors, known to the investigator, that would prevent or restrict participation in the audiological evaluations. * Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling. * Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this investigation. * Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Difference Between Standard and Novel Fitting Method for Monosyllabic Word Scores in Quiet | 0 to 4 weeks after fitting | The difference between mean CNC scores (reported as percentage of correct answers) in quiet between the standard and novel fitting method |
Countries
Australia, Belgium
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Study Cohort Recipients of cochlear implant or suitable for implantation
Recipients received standard and novel fitting methods during the study | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Study Cohort | — |
|---|---|---|
| Age, Continuous | 66.5 years | — |
| Average period of CI experience | 5.3 years | — |
| Device type CI24RE(CA) | 1 Participants | — |
| Device type CI24RE(CS) | 1 Participants | — |
| Device type CI512 | 3 Participants | — |
| Device type CI532 | 11 Participants | — |
| Device type CI612 | 1 Participants | — |
| Device type CI632 | 3 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 8 Participants | — |
| Sex: Female, Male Male | 12 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 5 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Mean Difference Between Standard and Novel Fitting Method for Monosyllabic Word Scores in Quiet
The difference between mean CNC scores (reported as percentage of correct answers) in quiet between the standard and novel fitting method
Time frame: 0 to 4 weeks after fitting
Population: All study recipients received the standard and novel fitting methods at different timepoints of the study.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Study Cohort | Mean Difference Between Standard and Novel Fitting Method for Monosyllabic Word Scores in Quiet | 3.8 difference in percentage correct answers |