Trial Outcomes & Findings for 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 (NCT NCT06173687)

Results Overview

Median of the standard deviation in total electrode impedance (measured in kOhm, averaged across 22 electrode contacts) between days for 8 weeks.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

51 participants

Primary outcome timeframe

8 Weeks

Results posted on

2025-12-03

Participant milestones
Measure	All Participants The impedance measurement task using the Mobile Research App (MRA): Characterisation of impedance and real-world monitoring of hearing difficulty in range of listening environments.
Overall Study STARTED	51
Overall Study COMPLETED	45
Overall Study NOT COMPLETED	6

Withdrawal data not reported

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	All Participants n=51 Participants The impedance measurement task using the Mobile Research App (MRA): Characterisation of impedance and real-world monitoring of hearing difficulty in range of listening environments.
Age, Continuous	65 years n=51 Participants
Sex: Female, Male Female	29 Participants n=51 Participants
Sex: Female, Male Male	22 Participants n=51 Participants
Cochlear implant experience	5.7 years n=51 Participants

Timeframe: 8 Weeks

Median of the standard deviation in total electrode impedance (measured in kOhm, averaged across 22 electrode contacts) between days for 8 weeks.

Outcome measures
Measure	All Participants n=44 Participants The impedance measurement task using the Mobile Research App (MRA): Characterisation of impedance and real-world monitoring of hearing difficulty in range of listening environments.
Impedance Measurements	0.36 kOhm Interval 0.27 to 0.67

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events
Measure	All Participants n=51 participants at risk The impedance measurement task using the Mobile Research App (MRA): Characterisation of impedance and real-world monitoring of hearing difficulty in range of listening environments.
Cardiac disorders Tachycardia	2.0% 1/51 • 8 weeks
Nervous system disorders Epileptic seizures	2.0% 1/51 • 8 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myeloma	2.0% 1/51 • 8 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	2.0% 1/51 • 8 weeks

Adverse event data not reported

Cochlear Limited

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