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

NCT04610112 | Completed Results

• 1 other identifier: ABIntl-19-44
• 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 HiRes Ultra Cl HiFocus MS Electrode and HiRes Ultra 3D Cl HiFocus MS Electrode (Ultra X) under normal conditions of use as it is approved for this device.

Conditions

Cochlear Hearing Loss

Outcome Measures

Primary Outcomes (1)

• Freiburger Monosyllables Score in Quiet

  score in % correct (scale from 0 to 100% of correct answers)

  6 months

Secondary Outcomes (1)

• Speech Reception Theshold (SRT) in Noise

  6 months

Interventions

Cochlear implantation PROCEDURE

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)

Heilig Geist Hospital Bensheim

Bensheim, Hesse, 64625, Germany

Location

Unfallkrankenhaus Berlin (UKB

Berlin, State of Berlin, 12683, Germany

Location

Klinik für HNO-Heilkunde. Kopf- imd Halschirurgie

Mannheim, 68167, 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

Results Point of Contact

• Title: Caroline-Marie DELATTRE
• Organization: Advanced Bionics

caroline-marie.delattre@advancedbionics.com

0788667472

Study Officials

• Arneborg Ernst, Prof. Dr.

  Unfallkrankenhaus Berlin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: October 30, 2020
• Study Start: September 16, 2020
• Primary Completion: May 21, 2025
• Study Completion: May 21, 2025
• Last Updated: March 25, 2026
• Results First Posted: March 25, 2026

Record last verified: 2026-02

Locations

DE (3)