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

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

      • Hanover, Germany, D-30625
        • Medizinische Hochschule Hannover

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.

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

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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