Cochlear Hearing Loss Clinical Trial
Official title:
Clinical Investigation of the Safety and Performance of HiResTM Ultra Cl HiFocusTM SlimJ Electrode (Cl-1600-05) and HiResTM Ultra 3D Cl HiFocusTM SlimJ Electrode (Cl-1601-05) (Ultra X) in Adults With Severe-to-profound Hearing Loss
NCT number | NCT04929470 |
Other study ID # | ABIntl-19-45 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 6, 2021 |
Est. completion date | July 2025 |
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | July 2025 |
Est. primary completion date | July 2025 |
Accepts healthy volunteers | |
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. |
Country | Name | City | State |
---|---|---|---|
Germany | Unfallkrankenhaus Berlin (UKB) | Berlin | |
Germany | HNO-Klinik Düsseldorf | Düsseldorf | |
Germany | Westfälische Wilhelms-Universität Münster | Münster |
Lead Sponsor | Collaborator |
---|---|
Advanced Bionics AG |
Germany,
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 | hours of usage | hours of usage as summarized in the logging of the processor | 6 months | |
Other | using habits of participants | 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 |
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