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

NCT04929470 | Active Not Recruiting FDA Device

• 1 other identifier: ABIntl-19-45
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Cochlear Hearing Loss

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Analysis of Speech reception threshold

  6 months

Other Outcomes (6)

• Device fitting data

  6 months

• Device verification data

  6 months

• Professional feedback from the audiologist using the latest fitting software to program the latest processor

  6 months

Interventions

cochlear implantation DEVICE

patients receive a cochlear implantation within clinical routine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

30 adult subjects with valid and useable data

You may qualify if:

• No previous experience with any auditory implant
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Advanced Bionics AG: lead

Study Sites (3)

HNO-Klinik Düsseldorf

Düsseldorf, Düsseldorf, 40225, Germany

Location

Unfallkrankenhaus Berlin (UKB)

Berlin, State of Berlin, 12683, Germany

Location

Westfälische Wilhelms-Universität Münster

Münster, Germany

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Interventions

Cochlear Implantation

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Otologic Surgical Procedures; Otorhinolaryngologic Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation

Study Officials

• Arneborg Ernst, Prof. Dr.

  Unfallkrankenhaus Berlin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2021
• First Posted: June 18, 2021
• Study Start: July 6, 2021
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: September 29, 2025

Record last verified: 2025-09

Locations

DE (3)