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

Cochlear Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04610112
• Other study ID #: ABIntl-19-44
• Status: Recruiting
• Start date: September 16, 2020
• Est. completion date: May 2025

Study information

• Verified date: January 2024
• Source: Advanced Bionics AG
• Contact: Arneborg Ernst, Prof. Dr.
• Phone: +49 (0) 30 56 81-4301
• Email: Arneborg.Ernst[@]ukb.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cochlear Hearing Loss
• Deafness
• Hearing Loss
• Hearing Loss, Sensorineural

Intervention

Device:
• cochlear implantation
patients receive a cochlear implantation within clinical routine

Locations

Country	Name	City	State
Germany	Unfallkrankenhaus Berlin (UKB	Berlin
Germany	Klinik für HNO-Heilkunde. Kopf- imd Halschirurgie	Mannheim

Sponsors (1)

Lead Sponsor	Collaborator
Advanced Bionics AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Device fitting data	M-level [CU] CU=Clinical Units	6 months
Other	Device verification data	Impedances [Kilo Ohm]	6 months
Other	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
Other	Feedback from the surgeon on handling of the device and tools during implantation	Feedback will be collected with a structured questionnaire	6 months
Other	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
Other	Using habits of participants assessed in a patient questionnaire	Assessement with a structured patient questionnaire	6 months
Primary	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
Primary	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	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