- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06301568
Retrospective Analysis of Long-term Speech Performance in Cochlear Implant Recipients Using Electro-acoustic Stimulation
April 2, 2026 updated by: Advanced Bionics AG
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 Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
55
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Hanover, Germany, D-30625
- Medizinische Hochschule Hannover
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
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)
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- no exclusion criteria
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
The Freiburger monosyllabic word test is performed 12 months after device activation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Percent correct in either the HSM sentence test or the Oldenburger sentence test (score from 0 to 100%)
|
The test (HSM or OlSa) is performed 12 months after device activation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Andreas Büchner, Hannover Medical School
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 22, 2024
Primary Completion (Actual)
September 1, 2024
Study Completion (Actual)
December 2, 2024
Study Registration Dates
First Submitted
March 4, 2024
First Submitted That Met QC Criteria
March 4, 2024
First Posted (Actual)
March 8, 2024
Study Record Updates
Last Update Posted (Actual)
April 14, 2026
Last Update Submitted That Met QC Criteria
April 2, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ABIntl-23-12
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cochlear Hearing Loss
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Cambridge University Hospitals NHS Foundation TrustAdvanced Bionics AGCompletedHearing Loss, Bilateral | Cochlear Implant | Hearing Loss, Cochlear | Severe-Profound Hearing LossUnited Kingdom
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Xiong haoRecruitingCochlear Hearing Loss | Cochlear Implant UsersChina
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iotaMotion, Inc.RecruitingHearing Loss, Sensorineural | Cochlear Implantation | Hearing Loss, CochlearUnited States
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University GhentCompletedHearing Loss, Sensorineural | Cochlear Hearing Loss | DFNA9 | Cochlear SynaptopathyBelgium
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