An observational study in Cochlear Hearing Loss, sponsored by Advanced Bionics AG. Completed at 3 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-12.
Sponsored by Advanced Bionics AG · Observational
This is a prospective study designed to evaluate the safety and performance of the HiResTM Ultra Cl HiFocusTM SlimJ Electrode and HiResTM Ultra 3D Cl HiFocusTM SlimJ Electrode (Ultra X) under normal conditions of use as it is approved for this device. Participants receive interventions as part of routine medical care.
This study is set up to document any adverse events and comparing pre- to post-implant benefit to subjects. Any adverse events associated with the device will be documented via Advanced Bionics complaint handling system for the lifetime of the device. A within-subjects repeated-measures design will be employed. Speech perception will be evaluated preoperatively with conventional amplification to determine candidacy and to establish baseline performance. Efficacy parameters are speech perception data which will be collected according to clinical routine with a 6 month follow up period. Subjects will be implanted unilaterally with the Ultra X according to standard clinical care.
The primary efficacy objective is to demonstrate that mean monosyllabic word recognition score with the Ultra X used in combination with a sound processor programmed with the latest fitting software six months after activation is at least 20% better than the mean word score at baseline with conventional amplification in the same ear.
The primary efficacy endpoint is reached six months after device activation.
371 studies on the registry are indexed under Hearing Loss, Sensorineural; 112 are open to participants now.
This study's enrollment of 37 is below the median of 78 across 93 observational studies indexed under Hearing Loss, Sensorineural.
Browse Hearing Loss, Sensorineural studies →Advanced Bionics AG is the lead sponsor of 12 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
30 adult subjects with valid and useable data
Exclusion Criteria:
patients receive a cochlear implantation within clinical routine
Freiburger Monosyllables Score in Quiet
score in % correct (scale from 0 to 100% of correct answers)
Time frame: 6 months
Speech Reception Theshold (SRT) in Noise
50 % SRT in the Oldenburger Sentence Test (OlSa) in noise. Results expressed in dB Signal-Noise-Ratio (SNR)
Time frame: 6 months
| Milestone | Group 1 |
|---|---|
| Started | 37 |
| Completed | 32 |
| Not completed | 5 |
score in % correct (scale from 0 to 100% of correct answers)
| % correct | Group 1 |
|---|---|
| Freiburger Monosyllables Score in Quiet | 51.1 ± 27.8 |
50 % SRT in the Oldenburger Sentence Test (OlSa) in noise. Results expressed in dB Signal-Noise-Ratio (SNR)
| dB SNR | Group 1 |
|---|---|
| Speech Reception Theshold (SRT) in Noise | 2.6 ± 6.2 |
Collected over Adverse event were collected from the inclusion until six months after device activation. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1 | 0/37 (0%) | 3/37 (8.1%) | 25/37 (67.6%) |
| Event | Group 1 |
|---|---|
| Heart attackCardiac disorders | 1/37 |
| Fall down the stairsGeneral disorders | 1/37 |
| Electrode lead dislocationEar and labyrinth disorders | 1/37 |
| InfectionSkin and subcutaneous tissue disorders | 1/37 |
| Event | Group 1 |
|---|---|
| Deterioration of CI side or controlateral side tinnitusEar and labyrinth disorders | 8/37 |
| Pain or pressure feelings at the implant sideEar and labyrinth disorders | 8/37 |
| Deactivated electrodesEar and labyrinth disorders | 7/37 |
| Deterioration of vertigoEar and labyrinth disorders | 6/37 |
| Sound interruptionsProduct Issues | 4/37 |
| Retention issuesProduct Issues | 1/37 |
| Overly loud or unpleasant sounds and sensationsProduct Issues | 1/37 |
| HeadachesGeneral disorders | 1/37 |
| Health issues (sickness)General disorders | 1/37 |
| Age, Continuous(years) | Group 1 |
|---|---|
| Mean | 67.2 ± 12.8 |
| Sex: Female, Male(Participants) | Group 1 |
|---|---|
| Female | 10 |
| Male | 22 |
| Race and Ethnicity Not Collected(Participants) | Group 1 |
|---|
| Age of onset of hearing loss(years) | Group 1 |
|---|---|
| Mean | 45.8 ± 19.8 |
| Age of onset of hsevere earing loss(years) | Group 1 |
|---|---|
| Mean | 49.9 ± 21.1 |
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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Advanced Bionics AG