NCT06301581

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 22, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 4, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 8, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

March 8, 2024

Status Verified

March 1, 2024

Enrollment Period

1.9 years

First QC Date

March 4, 2024

Last Update Submit

March 4, 2024

Conditions

Cochlear Hearing Loss

Outcome Measures

Primary Outcomes (1)

  • Freiburger monosyllabic word recognition score in quiet in the implanted ear

    Score obtained with the Freiburger Monosyllabic word test

    12 months after device activation

Study Arms (2)

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medizinische Hochschule Hannover

Hanover, D-30625, Germany

RECRUITING

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Andreas Büchner

    Hannover Medical School

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreas Büchner, Prof

CONTACT

49 511 532 8589buechner.andreas@mh-hannover.de

Kliesch Sven

CONTACT

49 511 532 8069Kliesch.Sven@mh-hannover.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2024

First Posted

March 8, 2024

Study Start

January 22, 2024

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

March 8, 2024

Record last verified: 2024-03

Locations

DE(1)