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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06301581

Enrollment

200

Registered

2024-03-08

Start date

2024-01-22

Completion date

2025-12-31

Last updated

2024-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cochlear Hearing Loss

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Germany

Contacts

Primary ContactAndreas Büchner, Prof

buechner.andreas@mh-hannover.de49 511 532 8589

Backup ContactKliesch Sven

Kliesch.Sven@mh-hannover.de49 511 532 8069

Outcome results