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Clinical Trials/NCT06301581
NCT06301581RecruitingNot Applicable

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

Advanced Bionics AG1 site in 1 country200 target enrollmentStarted: January 22, 2024Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
200
Locations
1
Primary Endpoint
Freiburger monosyllabic word recognition score in quiet in the implanted ear
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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