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| Name | Class |
|---|---|
| Medizinische Universität Innsbruck, Universitätsklinik für Hör-, Stimm-, und Sprachstörungen | UNKNOWN |
| Universitätsklinikum St. Pölten - NÖ Landeskliniken, Universitätsklinikum für Hals-, Nasen-, Ohrenkrankheiten | UNKNOWN |
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Cochlear implants help individuals with hearing loss by delivering electrical signals directly to the auditory nerve, bypassing damaged parts of the ear. While they significantly improve speech perception in quiet environments and over the telephone, challenges remain in noisy environments due to interference from background noise. To address this, advancements in signal-processing strategies, microphone technology, and noise-reduction algorithms have been introduced.
The focus of the study is on two new front-end features:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult MED-EL Cochlear implant users with post-lingual, severe to profound sensory-neural hearing los | Experimental | Testing new versus approved front-end features (within subject design) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testing new front-end features | Other | New front-end features (i,e, the Focused Beamformer which nhances directional hearing and the AI Mode Medium (utilizes adaptive intelligence for optimized sound processing) will be compared to the approved beamformer and AI mode) in a within subject design. Subjects will be fitted with a MED-EL SONNET 3 audio processor. |
| Measure | Description | Time Frame |
|---|---|---|
| Oldenburg Sentence Test in noise (S0 N±135) | Speech perception in noise measured in dB SNR (the new Focused beamformer and the Omnidirectional setting are tested) | immediately after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Oldenburg Sentence Test in noise (S0 N±135) | Speech perception in noise measured in dB SNR (the new Focused beamformer and the Natural beamformer are tested) | immediately after the intervention |
| Oldenburg Sentence Test in noise (S0 N±135) |
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Inclusion Criteria:
Exclusion Criteria:
Lack of compliance with any inclusion criteria
CI user with contralateral hearing equal to or better than 30 dB (pure-tone average over the following frequencies: 250, 500, 1000, and 2000 Hz)
Implanted with C40X, or C40C on the ear to be tested
Implanted with an auditory brainstem implant (ABI) or Split electrode array
Known allergic reactions to components of the investigational medical device
Anything that, in the opinion of the Investigator, would
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Universität Innsbruck, Universitätsklinik für Hör-, Stimm-, und Sprachstörungen | Innsbruck | Austria | ||||
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Speech perception in noise measured in dB SNR (theAI-Medium and the AI-Mild mode are tested)
| immediately after the intervention |
| Universitätsklinikum St. Pölten, Abteilung für Hals-, Nasen- und Ohrenerkrankungen |
| Sankt Pölten |
| Austria |