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NCT06301568 Clinical Trial

Retrospective Analysis of Long-term Speech Performance in Cochlear Implant Recipients Using Electro-acoustic Stimulation

Cochlear Hearing Loss Clinical Trial

Official title:
Retrospective Analysis of Long-term Speech Performance in Cochlear Implant Recipients Using Electro-acoustic Stimulation

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06301568
Other study ID # ABIntl-23-12
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 22, 2024
Est. completion date May 2024

Study information
Verified date January 2024
Source Advanced Bionics AG
Contact Andreas Büchner
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 long-term speech perception results for cochlear implants recipients using electro-acoustic-stimulation as measured in the clinical routine and to confirm the performance of sound processors associated with acoustic earhooks.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date May 2024
Est. primary completion date April 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Being implanted with HiRes Ultra or HiRes Ultra 3D SlimJ - Being a user of the "acoustic earhook" system - Having provided informed consent regarding use of his/her data for research. Exclusion Criteria: - no exclusion criteria

Study Design

Related Conditions & MeSH terms

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 Percent correct in the Freiburger Monosyllabic Word test 12 months after device activation
Secondary HSM sentence score or OlSa recognition score in quiet percent correct in either the HSM sentence test or the Oldenburger sentence test 12 months after device activation
See also
  Status Clinical Trial Phase
Completed NCT03212924 - Listening Effort in Cochlear Implant Users N/A
Withdrawn NCT04041596 - Degree of Benefit From Low-Frequency Acoustic Amplification Using the Advanced Bionics Acoustic Earhook Phase 4
Recruiting NCT04610112 - PMCF on Safety and Performance of HiResTM Ultra/Ultra 3D Cl Mid-Scala Electrodes in Adults With Severe-to-profound Hearing Loss
Completed NCT04610216 - Investigation of the Automatic Technology on the Naída M Hearing Devices
Completed NCT03288753 - Comparison Between Neuro 1 and Neuro 2 Cochlear Implant Speech Processors N/A
Completed NCT03248856 - Triamcinolone Levels in Cochlear Perilymph Phase 1
Completed NCT04048239 - Development of a Robotic Minimally Invasive Pathway for Cochlear Implantation N/A
Completed NCT04815343 - Investigation of the Naída CI M90 Sound Processor in Various Acoustic Scenarios N/A
Completed NCT04145661 - Non-linear Frequency Compared to Conventional Processing in Patients With and Without Cochlear Dead Regions. N/A
Recruiting NCT06114680 - Evaluation of the CochSyn Test Prototype to Measure Cochlear Synaptopathy N/A
Completed NCT03756337 - Neuro 1 vs. Neuro 2 Sound Processors N/A
Completed NCT04120181 - A New Predictor Marker for Cochlear Implants Infection
Terminated NCT05586555 - A Monocentric Study Evaluating Pupillometry as an Objective Measurement for CI Fittings N/A
Recruiting NCT04929470 - Safety and Performance of Ultra/Ultra 3D Cl With HiFocus SlimJ Electrode in Adults With Severe-to-profound Hearing Loss
Completed NCT04183348 - Evaluation of the Effect of a Visio-Hearing Training Protocol on Spatial Hearing in Subjects With Hearing Loss N/A
Not yet recruiting NCT06420921 - MeasurIng and Restoring Auditory Awareness for Cochlear Implant Listeners in noisE N/A
Completed NCT06235073 - Robotic and Manual Cochlear Implantation: An Intra-individual Study of Speech Recognition and Electrode Holder Position (ICRobMan)
Recruiting NCT05486637 - Vocal Emotion Communication With Cochlear Implants Early Phase 1
Recruiting NCT06301581 - Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant
Withdrawn NCT04651660 - Using Electrocochleography During Cochlear Implantation of the Neuro Zti. N/A