Trial Outcomes & Findings for Safety and Performance of HiRes Ultra/Ultra 3D Cl Mid-Scala Electrodes in Adults With Severe-to-profound Hearing Loss (NCT NCT04610112)
NCT ID: NCT04610112
Last Updated: 2026-03-25
Results Overview
score in % correct (scale from 0 to 100% of correct answers)
Recruitment status
COMPLETED
Target enrollment
30 participants
Primary outcome timeframe
6 months
Results posted on
2026-03-25
Participant Flow
Participant milestones
| Measure |
Group1
Ultra CI MS electrode
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group1
n=30 Participants
Ultra CI MS electrode
|
|---|---|
|
Age, Continuous
|
68.5 years
STANDARD_DEVIATION 12.6 • n=30 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=30 Participants
|
|
Age of onset of hearing loss
|
39.6 years
STANDARD_DEVIATION 22.9 • n=30 Participants
|
|
Age of onset of severe hearing loss
|
52.6 years
STANDARD_DEVIATION 17 • n=30 Participants
|
PRIMARY outcome
Timeframe: 6 monthsscore in % correct (scale from 0 to 100% of correct answers)
Outcome measures
| Measure |
Group1
n=30 Participants
Ultra CI MS electrode
|
|---|---|
|
Freiburger Monosyllables Score in Quiet
|
54.58 % correct
Standard Deviation 26.84
|
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 %. 22 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 |
Group1
n=22 Participants
Ultra CI MS electrode
|
|---|---|
|
Speech Reception Theshold (SRT) in Noise
|
1.69 dB SNR
Standard Deviation 4.34
|
Adverse Events
Group1
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group1
n=30 participants at risk
Ultra CI MS electrode
|
|---|---|
|
Ear and labyrinth disorders
Deterioration of vertigo
|
30.0%
9/30 • Adverse event were collected from the inclusion until six months after device activation
|
|
Ear and labyrinth disorders
- Deterioration of CI side or contralateral side tinnitus
|
30.0%
9/30 • Adverse event were collected from the inclusion until six months after device activation
|
|
Ear and labyrinth disorders
- Deactivated electrodes following vertigo or unpleasant feelings
|
10.0%
3/30 • Adverse event were collected from the inclusion until six months after device activation
|
|
Product Issues
Retention issues
|
10.0%
3/30 • 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
|
20.0%
6/30 • Adverse event were collected from the inclusion until six months after device activation
|
|
Skin and subcutaneous tissue disorders
Skin irritation at the implant side
|
3.3%
1/30 • Adverse event were collected from the inclusion until six months after device activation
|
|
Product Issues
Broken parts or damage items
|
6.7%
2/30 • Adverse event were collected from the inclusion until six months after device activation
|
|
Product Issues
Sound interruptions
|
6.7%
2/30 • Adverse event were collected from the inclusion until six months after device activation
|
|
Product Issues
Overly loud or unpleasant sounds and sensations
|
16.7%
5/30 • Adverse event were collected from the inclusion until six months after device activation
|
|
General disorders
Health issues with no relationship with the devices
|
26.7%
8/30 • 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
Restriction type: OTHER