Safety and Performance of HiResTM Ultra/Ultra 3D Cl Mid-Scala Electrodes in Adults With Severe-to-profound Hearing Loss

NCT ID: NCT04610112

Last Updated: 2024-10-30

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-16
• Study Completion Date: 2025-05-31

Brief Summary

This is a prospective study designed to evaluate the safety and performance of the HiResTM Ultra Cl HiFocusTM MS Electrode and HiResTM Ultra 3D Cl HiFocusTM MS Electrode (Ultra X) under normal conditions of use as it is approved for this device.

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.

Conditions

Cochlear Hearing Loss

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

cochlear implantation

patients receive a cochlear implantation within clinical routine

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Advanced Bionics AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arneborg Ernst, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Unfallkrankenhaus Berlin

Locations

Heilig Geist Hospital Bensheim

Bensheim, Hesse, Germany

Site Status: RECRUITING

Unfallkrankenhaus Berlin (UKB

Berlin, , Germany

Site Status: RECRUITING

Klinik für HNO-Heilkunde. Kopf- imd Halschirurgie

Mannheim, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Arneborg Ernst, Prof. Dr.

Role: CONTACT

Arneborg.Ernst@ukb.de

+49 (0) 30 56 81-4301

Facility Contacts

Jérôme Servais, Dr.

Role: primary

Jerome.Servais@artemed.de

06251 132 - 7500

Arneborg Ernst, Prof. Dr.

Role: primary

Arneborg.Ernst@ukb.de

+49 (0) 30 56 81-4301

Angela Schell, Dr. med.

Role: primary

Angela.Schell@umm.de

+49 (0) 621/383-0

Other Identifiers

ABIntl-19-44

Identifier Type: -

Identifier Source: org_study_id