Cochlear Hearing Loss
Conditions
Brief summary
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.
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.
Interventions
DEVICEcochlear implantation
patients receive a cochlear implantation within clinical routine
Sponsors
Advanced Bionics AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freiburger Monosyllables Score in Quiet | 6 months | score in % correct (scale from 0 to 100% of correct answers) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Speech Reception Theshold (SRT) in Noise | 6 months | 50 % SRT in the Oldenburger Sentence Test (OlSa) in noise. Results expressed in dB Signal-Noise-Ratio (SNR) |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORArneborg Ernst, Prof. Dr.
Unfallkrankenhaus Berlin
Participant flow
Pre-assignment details
37 subjects were screened and enrolled in the study. 5 sujects were excluded during the study. 32 subjects have finally completed all visits.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 67.2 years STANDARD_DEVIATION 12.8 |
| Age of onset of hearing loss | 45.8 years STANDARD_DEVIATION 19.8 |
| Age of onset of hsevere earing loss | 49.9 years STANDARD_DEVIATION 21.1 |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 37 |
| other Total, other adverse events | 25 / 37 |
| serious Total, serious adverse events | 3 / 37 |
Outcome results
None listed