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

Clinical Investigation of the Safety and Performance of HiRes Ultra Cl HiFocus MS Electrode (Cl-1600-04) and HiRes Ultra 3D Cl HiFocus MS Electrode (Cl-1601-04) (Ultra X Implants) in Adults With Severe-to-profound Hearing Loss

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.

Study Overview

• Status: Completed
• Conditions: Cochlear Hearing Loss
• Intervention / Treatment: Procedure: 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 (Actual): 30

Contacts and Locations

Study Locations

• Germany
  • Mannheim, Germany, 68167
    • Klinik für HNO-Heilkunde. Kopf- imd Halschirurgie
  • Hesse
    • Bensheim, Hesse, Germany, 64625
      • Heilig Geist Hospital Bensheim
  • State of Berlin
    • Berlin, State of Berlin, Germany, 12683
      • Unfallkrankenhaus Berlin (UKB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 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?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freiburger Monosyllables Score in Quiet	score in % correct (scale from 0 to 100% of correct answers)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speech Reception Theshold (SRT) in Noise	50 % SRT in the Oldenburger Sentence Test (OlSa) in noise. Results expressed in dB Signal-Noise-Ratio (SNR)	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
Using habits of participants as summarized in the logging of the processor	logging data in hours of usage logging of the processor and assessed in a patient questionnaire	6 months
Using habits of participants assessed in a patient questionnaire	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): September 16, 2020
• Primary Completion (Actual): May 21, 2025
• Study Completion (Actual): May 21, 2025

Study Registration Dates

• First Submitted: September 22, 2020
• First Submitted That Met QC Criteria: October 26, 2020
• First Posted (Actual): October 30, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Loss; Hearing Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hearing Loss, Sensorineural; Surgical Procedures, Operative; Prosthesis Implantation; Otorhinolaryngologic Surgical Procedures; Otologic Surgical Procedures; Cochlear Implantation
• Other Study ID Numbers: ABIntl-19-44

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: No