Cochlear Hearing LossNCT06301568
Retrospective Analysis of Long-term Speech Performance in Cochlear Implant Recipients Using Electro-acoustic Stimulation
An observational study of Cochlear Hearing Loss, run by Advanced Bionics AG at 1 site in Germany.
Trial summary
This is a retrospective study designed to collect long-term speech perception results for cochlear implants recipients using electro-acoustic-stimulation as measured in the clinical routine and to confirm the performance of sound processors associated with acoustic earhooks. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cochlear Hearing Loss
- How many people
- 55 participants
- Where
- 1 siteGermany
- Study dates
- 22 Jan 2024to 2 Dec 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The studied population consists of all CI users implanted with a HiRes Ultra or HiRes Ultra 3D SlimJ between January 2017 and August 2022 and using an acoustic earhook at the Medical University of Hannover in Germany (MHH)
Who may be able to join
- Being implanted with HiRes Ultra or HiRes Ultra 3D SlimJ
- Being a user of the "acoustic earhook" system
- Having provided informed consent regarding use of his/her data for research.
Who cannot join
- no exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
This is a retrospective study designed to collect long-term speech perception results for cochlear implants recipients using electro-acoustic-stimulation as measured in the clinical routine and to confirm the performance of sound processors associated with acoustic earhooks.
- Conditions
- Cochlear Hearing Loss
- Medical subject headings
- Hearing Loss, Sensorineural
What is being measured
The primary outcome is the main question the study is designed to answer.
Freiburger Monosyllabic Word Recognition Score in Quiet
Percent correct in the Freiburger Monosyllabic Word test
Measured: The Freiburger monosyllabic word test is performed 12 months after device activation
Secondary outcomes (1)
Hochmair-Desoyer Schultz and Moser (HSM) Sentence Score or Oldenburger Sentence Test (OlSa) Recognition Score in Quiet
Percent correct in either the HSM sentence test or the Oldenburger sentence test (score from 0 to 100%)
Measured: The test (HSM or OlSa) is performed 12 months after device activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start22 Jan 2024
- Primary completion1 Sep 2024
- Study completion2 Dec 2024
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
- Retrospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Bionics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andreas Büchner, Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06301568
- Sponsor's protocol ID
- ABIntl-23-12
- Status last verified
- Feb 2026
- First submitted
- 4 Mar 2024
- Last updated
- 14 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of Long-term Speech Performance in Cochlear Implant Recipients Using Electro-acoustic Stimulation
- ClinicalTrials.gov ID
- NCT06301568
- Acronym / sponsor ID
- ABIntl-23-12
- Conditions
- Cochlear Hearing Loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Advanced Bionics AGIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 2 Dec 2024 (actual)
- First posted
- 8 Mar 2024 (actual)
- Results
- Posted 14 Apr 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 retrospective study designed to collect long-term speech perception results for cochlear implants recipients using electro-acoustic-stimulation as measured in the clinical routine and to confirm the performance of sound processors associated with acoustic earhooks.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The studied population consists of all CI users implanted with a HiRes Ultra or HiRes Ultra 3D SlimJ between January 2017 and August 2022 and using an acoustic earhook at the Medical University of Hannover in Germany (MHH)
Key inclusion criteria (3 listed)
- Being implanted with HiRes Ultra or HiRes Ultra 3D SlimJ
- Being a user of the "acoustic earhook" system
- Having provided informed consent regarding use of his/her data for research.
Key exclusion criteria (1 listed)
- no exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Freiburger Monosyllabic Word Recognition Score in Quiet
Time frame: The Freiburger monosyllabic word test is performed 12 months after device activation
Percent correct in the Freiburger Monosyllabic Word test
1 secondary outcome
Hochmair-Desoyer Schultz and Moser (HSM) Sentence Score or Oldenburger Sentence Test (OlSa) Recognition Score in Quiet
Time frame: The test (HSM or OlSa) is performed 12 months after device activation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Andreas Büchner principal investigator
Hannover Medical School
1 site 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 1 site 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 3 inclusion and 1 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 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 14 Apr 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 Monosyllabic Word Recognition Score in Quiet (time frame: The Freiburger monosyllabic word test is performed 12 months after device activation). 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 14 Apr 2026.