Hearing Loss
Conditions
Brief summary
The aim of this descriptive study is to collect and describe the characteristics of objective measures to explore the specificity of algorithms.
Interventions
DEVICEObjective measures with CSEP
Objective measures to be conducted with Custom SoundTM EP 5 software and the CP900 series sound processor in CI532 and CI512 Cochlear Implant recipients
Sponsors
Cochlear
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Candidate for cochlear implantation with the CI532 or CI512 devices * 18 years of age or older at the time of enrolment * Normal cochlea anatomy, established via pre-operative Computer Tomography * Willingness to participate in and to comply with all requirements of the protocol
Exclusion criteria
* Prior cochlear implantation in the ear to be implanted * Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array * Abnormal cochlear anatomy on pre-operative Computer Tomography or Magnetic Resonance Imaging * Additional handicaps that would prevent participation in evaluations * Pregnant and breast feeding women, prisoners, or anyone in custody * Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Specificity (%) of Transimpedance Measurement to Identify Electrode Fold-over | at surgery, within one minute | Measured with Custom SoundTM EP 5. It took one minute to measure all electrodes in surgery. Intraoperative transimpedance measures from 148 ears without fold-overs (as evidenced by radiographic imaging) were analysed to assess the specificity of the algorithm. |
Countries
Australia, Germany, Spain
Participant flow
Recruitment details
153 participants were recruited in six centres from 03 October 2017 to 29 May 2019.
Participants by arm
| Arm | Count |
|---|---|
| Cochlear Implant Recipients CI532 and CI512 cochlear implant recipients | 152 |
| Total | 152 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Cochlear Implant Recipients | — |
|---|---|---|
| Age, Continuous | 58 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Australia | 9 Participants | — |
| Region of Enrollment Germany | 115 Participants | — |
| Region of Enrollment Spain | 28 Participants | — |
| Sex: Female, Male Female | 79 Participants | — |
| Sex: Female, Male Male | 73 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 153 |
| other Total, other adverse events | 0 / 153 |
| serious Total, serious adverse events | 2 / 153 |
Outcome results
Primary
Specificity (%) of Transimpedance Measurement to Identify Electrode Fold-over
Measured with Custom SoundTM EP 5. It took one minute to measure all electrodes in surgery. Intraoperative transimpedance measures from 148 ears without fold-overs (as evidenced by radiographic imaging) were analysed to assess the specificity of the algorithm.
Time frame: at surgery, within one minute
Population: 148 ears were analyzed from 145 participants (with three bilateral participants providing 148 ears). From the 152 baseline participants, seven were excluded from the analysis: for three participants, no transimpedance data were obtained intra-operatively and for four participants the transimpedance data showed measurement abnormalities.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cochlear Implant Recipients | Specificity (%) of Transimpedance Measurement to Identify Electrode Fold-over | 98.6 Percentage of ears |