Safety and Performance of Ultra/Ultra 3D Cl With HiFocus SlimJ Electrode in Adults With Severe-to-profound Hearing Loss

Clinical Investigation of the Safety and Performance of HiResTM Ultra Cl HiFocusTM SlimJ Electrode (Cl-1600-05) and HiResTM Ultra 3D Cl HiFocusTM SlimJ Electrode (Cl-1601-05) (Ultra X) in Adults With Severe-to-profound Hearing Loss

This is a prospective study designed to evaluate the safety and performance of the HiResTM Ultra Cl HiFocusTM SlimJ Electrode and HiResTM Ultra 3D Cl HiFocusTM SlimJ Electrode (Ultra X) under normal conditions of use as it is approved for this device. Participants receive interventions as part of routine medical care.

Study Overview

• Status: Recruiting
• Conditions: Cochlear Hearing Loss
• Intervention / Treatment: Device: cochlear implantation

Detailed Description

This study is set up to document any adverse events and comparing pre- to post-implant benefit to subjects. Any adverse events associated with the device will be documented via Advanced Bionics complaint handling system for the lifetime of the device. A within-subjects repeated-measures design will be employed. Speech perception will be evaluated preoperatively with conventional amplification to determine candidacy and to establish baseline performance. Efficacy parameters are speech perception data which will be collected according to clinical routine with a 6 month follow up period. Subjects will be implanted unilaterally with the Ultra X according to standard clinical care.

The primary efficacy objective is to demonstrate that mean monosyllabic word recognition score with the Ultra X used in combination with a sound processor programmed with the latest fitting software six months after activation is at least 20% better than the mean word score at baseline with conventional amplification in the same ear.

The primary efficacy endpoint is reached six months after device activation.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Arneborg Ernst, Prof. Dr.; Phone Number: +49 (0) 30 56 81-4301; Email: Arneborg.Ernst@ukb.de

Study Locations

• Germany
  • Berlin, Germany, 12683
    • Recruiting
    • Unfallkrankenhaus Berlin (UKB)
    • Contact: Arneborg Ernst, Prof. Dr.; Phone Number: +49 (0) 30 56 81-4301; Email: Arneborg.Ernst@ukb.de
  • Düsseldorf, Germany, 40225
    • Recruiting
    • HNO-Klinik Düsseldorf
    • Contact: Thomas Klenzner, Prof Dr Dr; Phone Number: 00492118117576; Email: Thomas@Klenzner@med.uni-duesseldorf.de
  • Münster, Germany
    • Recruiting
    • Westfälische Wilhelms-Universität Münster
    • Contact: Katrin Neumann, Prof.
    • Contact: Claudia Rudack, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

30 adult subjects with valid and useable data

Description

Inclusion Criteria:

• No previous experience with any auditory implant
• 18 years of age or older
• Postlingual onset of severe hearing loss (≥ 4 years of age)
• Limited benefit from appropriately fitted hearing aids, defined as scoring 60% or less in Freiburger Monosyllabic word test
• German language proficiency
• Willingness to participate in all scheduled procedures outlined in the protocol

Exclusion Criteria:

• Cochlear malformation or obstruction that would preclude full insertion of electrode array.
• Presence of additional disabilities that would prevent or interfere with participation in the required study procedures
• Medical or psychological conditions that contraindicate surgery or impact the ability to manage an implanted device or the study related procedures
• Evidence of central auditory lesion or compromised auditory nerve
• Pregnancy at time of surgery.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speech recognition score (word score)	The primary efficacy objective is to demonstrate that mean monosyllabic word recognition score (Minimum Score 0 percent and maximum score 100 percent wheras 0 percent is worse and 100 is better) with the Ultra implants used in combination with a sound processor programmed with the latest fitting software is at least 20 percent better than the mean monosyllabic word score at baseline with conventional amplification in the same ear.	6 months
Analysis of participants with device failure	A maximum of one device failure that require device replacement during the first six months following device activation (activation approximately one to eight weeks after surgery).	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis of Speech reception threshold	50 percent speech reception threshold in the Oldenburger Sentence Test (OlSa) in noise in the implanted ear six months after device activation compared to baseline performance with conventional amplification in the same ear.	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device fitting data	M-level [CU] CU=Clinical Units	6 months
Device verification data	Impedances [Kilo Ohm]	6 months
Professional feedback from the audiologist using the latest fitting software to program the latest processor	Feedback will be collected with a structured questionnaire	6 months
Feedback from the surgeon on handling of the device and tools during implantation	Feedback will be collected with a structured questionnaire	6 months
hours of usage	hours of usage as summarized in the logging of the processor	6 months
using habits of participants	Assessement with a structured patient questionnaire	6 months

Collaborators and Investigators

• Sponsor: Advanced Bionics AG
• Investigators: Principal Investigator: Arneborg Ernst, Prof. Dr., Unfallkrankenhaus Berlin

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2021
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: June 6, 2021
• First Submitted That Met QC Criteria: June 10, 2021
• First Posted (Actual): June 18, 2021

Study Record Updates

• Last Update Posted (Actual): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Sensorineural
• Other Study ID Numbers: ABIntl-19-45

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes