Clinical trial NCT04610112: Safety and Performance of HiResTM Ultra/Ultra 3D Cl Mid-Scala Electrodes in Adults With Severe-to-profound Hearing Loss
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cochlear Hearing Loss
Lead sponsor: Advanced Bionics AG
Sponsor class: INDUSTRY
First posted: 2020-10-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 30 adult subjects with valid and useable data

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.

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.

Primary outcomes:
measure: Speech recognition score (word score)
timeFrame: 6 months
measure: Analysis of participants with device failure
timeFrame: 6 months
Secondary outcomes:
measure: Analysis of Speech reception threshold
timeFrame: 6 months
Other outcomes:
measure: Device fitting data
timeFrame: 6 months
measure: Device verification data
timeFrame: 6 months
measure: Professional feedback from the audiologist using the latest fitting software to program the latest processor
timeFrame: 6 months
measure: Feedback from the surgeon on handling of the device and tools during implantation
timeFrame: 6 months
measure: Using habits of participants as summarized in the logging of the processor
timeFrame: 6 months
measure: Using habits of participants assessed in a patient questionnaire
timeFrame: 6 months
Locations:
city: Bensheim
country: Germany
facility: Heilig Geist Hospital Bensheim
state: Hessen
city: Berlin
country: Germany
facility: Unfallkrankenhaus Berlin (UKB
city: Mannheim
country: Germany
facility: Klinik für HNO-Heilkunde. Kopf- imd Halschirurgie
Study officials:
affiliation: Unfallkrankenhaus Berlin
name: Arneborg Ernst, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: