Trial Outcomes & Findings for Safety and Performance of Ultra/Ultra 3D Cl With HiFocus SlimJ Electrode in Adults With Severe-to-profound Hearing Loss (NCT NCT04929470)
NCT ID: NCT04929470
Last Updated: 2026-06-12
Results Overview
score in % correct (scale from 0 to 100% of correct answers)
Recruitment status
COMPLETED
Target enrollment
37 participants
Primary outcome timeframe
6 months
Results posted on
2026-06-12
Participant Flow
37 subjects were screened and enrolled in the study. 5 sujects were excluded during the study. 32 subjects have finally completed all visits.
Participant milestones
| Measure |
Group 1
Ultra CI SlimJ electrode
|
|---|---|
|
Overall Study
STARTED
|
37
|
|
Overall Study
COMPLETED
|
32
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group 1
n=32 Participants
Ultra CI SlimJ electrode
|
|---|---|
|
Age, Continuous
|
67.2 years
STANDARD_DEVIATION 12.8 • n=32 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=32 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=32 Participants
|
|
Age of onset of hearing loss
|
45.8 years
STANDARD_DEVIATION 19.8 • n=29 Participants • Hearing loss history was only available for 29 subjects
|
|
Age of onset of hsevere earing loss
|
49.9 years
STANDARD_DEVIATION 21.1 • n=29 Participants • Hearing loss history was only available for 29 subjects
|
PRIMARY outcome
Timeframe: 6 monthsscore in % correct (scale from 0 to 100% of correct answers)
Outcome measures
| Measure |
Group 1
n=32 Participants
Ultra CI SlimJ electrode
|
|---|---|
|
Freiburger Monosyllables Score in Quiet
|
51.1 % correct
Standard Deviation 27.8
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Speech intelligibility measurements in noise were optional for subjects with OlSa scores in quiet between 60% and 75% and mandatory for subjects with OlSa scores in quiet higher than 75 %. 27 subjects were able to perform the test in noise at the 6-months' visits.
50 % SRT in the Oldenburger Sentence Test (OlSa) in noise. Results expressed in dB Signal-Noise-Ratio (SNR)
Outcome measures
| Measure |
Group 1
n=27 Participants
Ultra CI SlimJ electrode
|
|---|---|
|
Speech Reception Theshold (SRT) in Noise
|
2.6 dB SNR
Standard Deviation 6.2
|
Adverse Events
Group 1
Serious events: 3 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1
n=37 participants at risk
Ultra CI SlimJ electrode
|
|---|---|
|
Cardiac disorders
Heart attack
|
2.7%
1/37 • Number of events 1 • Adverse event were collected from the inclusion until six months after device activation
|
|
General disorders
Fall down the stairs
|
2.7%
1/37 • Number of events 1 • Adverse event were collected from the inclusion until six months after device activation
|
|
Ear and labyrinth disorders
Electrode lead dislocation
|
2.7%
1/37 • Number of events 1 • Adverse event were collected from the inclusion until six months after device activation
|
|
Skin and subcutaneous tissue disorders
Infection
|
2.7%
1/37 • Number of events 1 • Adverse event were collected from the inclusion until six months after device activation
|
Other adverse events
| Measure |
Group 1
n=37 participants at risk
Ultra CI SlimJ electrode
|
|---|---|
|
Ear and labyrinth disorders
Deterioration of vertigo
|
16.2%
6/37 • Number of events 6 • Adverse event were collected from the inclusion until six months after device activation
|
|
Ear and labyrinth disorders
Deterioration of CI side or controlateral side tinnitus
|
21.6%
8/37 • Number of events 9 • Adverse event were collected from the inclusion until six months after device activation
|
|
Ear and labyrinth disorders
Deactivated electrodes
|
18.9%
7/37 • Number of events 7 • Adverse event were collected from the inclusion until six months after device activation
|
|
Product Issues
Retention issues
|
2.7%
1/37 • Number of events 1 • Adverse event were collected from the inclusion until six months after device activation
|
|
Ear and labyrinth disorders
Pain or pressure feelings at the implant side
|
21.6%
8/37 • Number of events 9 • Adverse event were collected from the inclusion until six months after device activation
|
|
Product Issues
Sound interruptions
|
10.8%
4/37 • Number of events 5 • Adverse event were collected from the inclusion until six months after device activation
|
|
Product Issues
Overly loud or unpleasant sounds and sensations
|
2.7%
1/37 • Number of events 1 • Adverse event were collected from the inclusion until six months after device activation
|
|
General disorders
Headaches
|
2.7%
1/37 • Number of events 1 • Adverse event were collected from the inclusion until six months after device activation
|
|
General disorders
Health issues (sickness)
|
2.7%
1/37 • Number of events 1 • Adverse event were collected from the inclusion until six months after device activation
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place