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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06301581
Other study ID # ABIntl-23-42
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 22, 2024
Est. completion date December 2025

Study information

Verified date March 2024
Source Advanced Bionics AG
Contact Andreas Büchner, Prof
Phone 49 511 532 8589
Email buechner.andreas@mh-hannover.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Locations

Country Name City State
Germany Medizinische Hochschule Hannover Hannover

Sponsors (1)

Lead Sponsor Collaborator
Advanced Bionics AG

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Freiburger monosyllabic word recognition score in quiet in the implanted ear Score obtained with the Freiburger Monosyllabic word test 12 months after device activation
See also
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