N/A
N=30
Safety and Performance of HiRes Ultra/Ultra 3D Cl Mid-Scala Electrodes in Adults With Severe-to-profound Hearing Loss
Cochlear Hearing Loss
Bottom Line
View on ClinicalTrials.gov: NCT04610112 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Freiburger Monosyllables Score in Quiet — 54.58 % correct
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Cochlear implantation (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Advanced Bionics AG
- Primary completion
- May 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Freiburger Monosyllables Score in Quiet |
54.58 | — |
| SECONDARY Speech Reception Theshold (SRT) in Noise |
1.69 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- No previous experience with any auditory implant
- 18 years of age or older
- Postlingual onset of severe hearing loss (≥ 4 years of age)
- Limited benefit from appropriately fitted hearing aids, defined as scoring 60% or less in Freiburger Monosyllabic word test
- German language proficiency
- Willingness to participate in all scheduled procedures outlined in the protocol
Exclusion Criteria
- Cochlear malformation or obstruction that would preclude full insertion of electrode array.
- Presence of additional disabilities that would prevent or interfere with participation in the required study procedures
- Medical or psychological conditions that contraindicate surgery or impact the ability to manage an implanted device or the study related procedures
- Evidence of central auditory lesion or compromised auditory nerve
- Pregnancy at time of surgery.
Data sourced from ClinicalTrials.gov (NCT04610112). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.