Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant

March 4, 2024 updated by: Advanced Bionics AG
This is a retrospective study designed to collect speech perception results for HiRes Ultra CI and HiRes Ultra 3D CI users as measured in the clinical routine and to confirm the performance of these devices.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Hannover, Germany, D-30625
        • Recruiting
        • Medizinische Hochschule Hannover
        • Contact:
          • Andreas Büchner
        • Principal Investigator:
          • Andreas Büchner

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 Version V2 or HiRes Ultra 3D Version V2 CI at the Medical University of Hannover in Germany (MHH).

Description

Inclusion Criteria:

  • Unilateral or bilateral HiRes Ultra CI or HiRes Ultra 3D CI users including

    • Ultra Version V2 newly implanted on this side (Group 1)
    • Ultra Version V2 users implanted following an Ultra Version V1 device failure in the same ear (Group 2)
  • Informed consent signed

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

Cohorts and Interventions

Group / Cohort
Group 1
HiRes Ultra or HiRes Ultra 3D Version V2 newly implanted on this side
Group 2
HiRes Ultra or HiRes Ultra 3D Version V2 implanted following an Ultra Version V1 device failure on the same ear

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freiburger monosyllabic word recognition score in quiet in the implanted ear
Time Frame: 12 months after device activation
Score obtained with the Freiburger Monosyllabic word test
12 months after device activation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Advanced Bionics AG

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 (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

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)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABIntl-23-42

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.

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