Freiburger Monosyllables Score in Quiet
Primary
· 6 months
score in % correct (scale from 0 to 100% of correct answers)
| Group | Value | 95% CI |
|---|---|---|
| Group1 | 54.58 | ± 26.84 |
Last reviewed · How we verify
NCT04610112
Safety and Performance of HiRes Ultra/Ultra 3D Cl Mid-Scala Electrodes in Adults With Severe-to-profound Hearing Loss
Completed
Results posted
Last updated 25 March 2026
What this trial tests
trial testing Cochlear implantation in Cochlear Hearing Loss in 30 participants. Completed in 21 May 2025.
Timeline
16 September 2020
Primary endpoint
21 May 2025
21 May 2025
21 May 2025
Quick facts
| Lead sponsor | Advanced Bionics AG |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 30 |
| Start date | 16 September 2020 |
| Primary completion | 21 May 2025 |
| Estimated completion | 21 May 2025 |
| Sites | 3 locations across Germany |
Drugs / interventions tested
- Cochlear implantation
Conditions studied
- Cochlear Hearing Loss — all drugs for Cochlear Hearing Loss →
Sponsor
Advanced Bionics AG — full company profile →
Who can join
18 and older, any sex, with Cochlear Hearing Loss. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Speech Reception Theshold (SRT) in Noise
Secondary
· 6 months
50 % SRT in the Oldenburger Sentence Test (OlSa) in noise. Results expressed in dB Signal-Noise-Ratio (SNR)
| Group | Value | 95% CI |
|---|---|---|
| Group1 | 1.69 | ± 4.34 |
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse event were collected from the inclusion until six months after device activation. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Group1
Serious: 0/30 (0%)
Deaths: 0/30
Other adverse events (10 terms — click to expand)
| Reaction | System | Group1 |
|---|---|---|
| Deterioration of vertigo | Ear and labyrinth disorders | — |
| - Deterioration of CI side or contralateral side tinnitus | Ear and labyrinth disorders | — |
| Health issues with no relationship with the devices | General disorders | — |
| Pain or pressure feelings at the implant side | Ear and labyrinth disorders | — |
| Overly loud or unpleasant sounds and sensations | Product Issues | — |
| - Deactivated electrodes following vertigo or unpleasant feelings | Ear and labyrinth disorders | — |
| Retention issues | Product Issues | — |
| Broken parts or damage items | Product Issues | — |
| Sound interruptions | Product Issues | — |
| Skin irritation at the implant side | Skin and subcutaneous tissue disorders | — |
Data from ClinicalTrials.gov NCT04610112 adverse events section.
Sponsor's own description
This is a prospective study designed to evaluate the safety and performance of the HiRes Ultra Cl HiFocus MS Electrode and HiRes Ultra 3D Cl HiFocus MS Electrode (Ultra X) under normal conditions of use as it is approved for this device.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04610112
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Cochlear implantation
Trials testing the same drug.
- NCT05079867 — Cochlear Trauma, Functional and Structural Preservation in Cochlear Implant Surgery · unknown
- NCT05052944 — Single-sided Deafness and Cochlear Implantation · completed
- NCT03382769 — Hearing Loss in Older Adults Study · NA · terminated
- NCT04934605 — Genotype-phenotype Correlation of SLC26A4 in CI Patients With EVA · unknown
Other recruiting trials for Cochlear Hearing Loss
Currently open trials in the same condition.
- NCT07509788 — Effects of Binaural Hearing on Listening Effort and Cognitive Development in Mandarin-speaking Children With Cochlear Im · recruiting
- NCT07068373 — Development of Evidence-based Therapeutic Guidelines for Early SLA in Urdu-speaking Children With Cochlear Implants · active not recruiting
- NCT06960616 — Improving Clinical Efficiency by Reducing Scheduled Follow-ups Using Cochlear America's Population Mean Mapping Strategy · NA · recruiting
- NCT05486637 — Vocal Emotion Communication With Cochlear Implants · EARLY_PHASE1 · recruiting
Other Advanced Bionics AG trials
Trials by the same sponsor.
- NCT06268340 — Hearing and Structure Preservation Via ECochG · NA · recruiting
- NCT06301568 — Retrospective Analysis of Long-term Speech Performance in Cochlear Implant Recipients Using Electro-acoustic Stimulation · completed
- NCT04815343 — Investigation of the Naída CI M90 Sound Processor in Various Acoustic Scenarios · NA · completed
- NCT04610216 — Investigation of the Automatic Technology on the Naída M Hearing Devices · completed
- NCT03078920 — Benefits of a Contralateral Routing of Signals (CROS) System in Unilateral CI-recipients · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT04610112 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Advanced Bionics AG
- Last refreshed: 25 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04610112.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing