Median of the standard deviation in total electrode impedance (measured in kOhm, averaged across 22 electrode contacts) between days for 8 weeks.
| Group | Value | 95% CI |
|---|---|---|
| All Participants | 0.36 | 0.27 – 0.67 |
Last reviewed · How we verify
Multi-center Study to Examine Changes to the Environment Surrounding the Electrodes in the Cochlea and to Capture the Most Challenging Listening Environments Experienced by Persons With a Cochlear Implant
NA trial testing The impedance measurement task using the Mobile Research App (MRA) in Hearing Loss in 51 participants. Completed in 24 October 2024.
| Lead sponsor | Cochlear |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 51 |
| Start date | 29 January 2024 |
| Primary completion | 24 October 2024 |
| Estimated completion | 24 October 2024 |
| Sites | 4 locations across Belgium, Sweden, Australia |
Cochlear — full company profile →
18 and older, any sex, with Hearing Loss. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Median of the standard deviation in total electrode impedance (measured in kOhm, averaged across 22 electrode contacts) between days for 8 weeks.
| Group | Value | 95% CI |
|---|---|---|
| All Participants | 0.36 | 0.27 – 0.67 |
Time frame: 8 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | All Participants |
|---|---|---|
| Tachycardia | Cardiac disorders | — |
| Epileptic seizures | Nervous system disorders | — |
| Myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
Most-reported serious reactions: Tachycardia, Epileptic seizures, Myeloma, Breast cancer.
Data from ClinicalTrials.gov NCT06173687 adverse events section.
This early feasibility study aims to collect pilot data on impedance measurements in real-world environments and to collect real-world and difficult listening situations and the factors impacting this, reflecting situations the subjects encounter during their daily life outside of the clinic. Improving the monitoring of both aspects may lead to improvements in monitoring and personalising the fitting to optimise hearing outcomes for persons with a cochlear implant.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing