Cochlear Hearing LossNCT04610112
Safety and Performance of HiRes Ultra/Ultra 3D Cl Mid-Scala Electrodes in Adults With Severe-to-profound Hearing Loss
An observational study of Cochlear Hearing Loss, run by Advanced Bionics AG at 3 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cochlear Hearing Loss
- What is being tested?
- Cochlear implantation
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 3 sitesGermany
- Study dates
- 16 Sep 2020to 21 May 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: 30 adult subjects with valid and useable data
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Heilig Geist Hospital Bensheim
Bensheim, Hesse, 64625
Unfallkrankenhaus Berlin (UKB
Berlin, State of Berlin, 12683
Klinik für HNO-Heilkunde. Kopf- imd Halschirurgie
Mannheim, 68167
About this study
Official title: Clinical Investigation of the Safety and Performance of HiRes Ultra Cl HiFocus MS Electrode (Cl-1600-04) and HiRes Ultra 3D Cl HiFocus MS Electrode (Cl-1601-04) (Ultra X Implants) in Adults With Severe-to-profound Hearing Loss
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.
Read the detailed description
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.
- Conditions
- Cochlear Hearing Loss
- Being tested
- Cochlear implantation
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cochlear implantationProcedure or surgery
patients receive a cochlear implantation within clinical routine
What is being measured
The primary outcome is the main question the study is designed to answer.
Freiburger Monosyllables Score in Quiet
score in % correct (scale from 0 to 100% of correct answers)
Measured: 6 months
Secondary outcomes (1)
Speech Reception Theshold (SRT) in Noise
50 % SRT in the Oldenburger Sentence Test (OlSa) in noise. Results expressed in dB Signal-Noise-Ratio (SNR)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start16 Sep 2020
- Primary completion21 May 2025
- Study completion21 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cochlear Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Bionics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arneborg Ernst, Prof. Dr., Principal investigator, Unfallkrankenhaus Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04610112
- Sponsor's protocol ID
- ABIntl-19-44
- Status last verified
- Feb 2026
- First submitted
- 22 Sep 2020
- Last updated
- 25 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of the Safety and Performance of HiRes Ultra Cl HiFocus MS Electrode (Cl-1600-04) and HiRes Ultra 3D Cl HiFocus MS Electrode (Cl-1601-04) (Ultra X Implants) in Adults With Severe-to-profound Hearing Loss
- ClinicalTrials.gov ID
- NCT04610112
- Acronym / sponsor ID
- ABIntl-19-44
- Conditions
- Cochlear Hearing Loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Advanced Bionics AGIndustry (pharma, biotech, devices)
- Study start
- 16 Sep 2020 (actual)
- Primary completion
- 21 May 2025 (actual)
- Study completion
- 21 May 2025 (actual)
- First posted
- 30 Oct 2020 (actual)
- Results
- Posted 25 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 30 adult subjects with valid and useable data
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cochlear implantationpatients receive a cochlear implantation within clinical routine | Procedure or surgery | – |
Primary outcome
Freiburger Monosyllables Score in Quiet
Time frame: 6 months
score in % correct (scale from 0 to 100% of correct answers)
1 secondary outcome
Speech Reception Theshold (SRT) in Noise
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Cochlear Hearing Loss
RecruitingObservational study
Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant
Cochlear Hearing Loss
RecruitingObservational study
Retrospectively Investigating Longitudinal Outcomes in MED-EL SONATA 2 Cochlear Implant Recipients.
Cochlear Implantation, Sensorineural Hearing Loss
Recruiting
Investigating Auditory Processing in the Users of Auditory Brainstem and Cochlear Implants
Deafness
Not yet recruitingObservational study
Mi2000 TICI Follow-up
Hearing Loss, Binaural, Cochlear Implantation
Not yet recruiting
Mi2000 TICI - Post-market Implantation Study
Hearing Loss, Binaural, Cochlear Implantation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arneborg Ernst, Prof. Dr. principal investigator
Unfallkrankenhaus Berlin
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cochlear Hearing Loss, run by Advanced Bionics AG at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freiburger Monosyllables Score in Quiet (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.