Status:
COMPLETED
Front-End Processing 3.0
Lead Sponsor:
MED-EL Elektromedizinische Geräte GesmbH
Conditions:
Hearing Loss
Hearing Loss, Sensorineural
Eligibility:
All Genders
18+ years
Brief Summary
This study investigated the impact of Automatic Sound Management 3.0 (i.e. ambient noise reduction, transient noise reduction and an adaptive intelligence) as implemented in the SONNET2 on CI users' s...
Detailed Description
MED-EL Cochlear Implants (CI) provide auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing-impaired individuals who obtain little or no benefit fr...
Eligibility Criteria
Inclusion
- A minimum of 18 years old
- Experienced user (≥ 6 months) of a MED-EL cochlear implant (CI; C40+ and later model)
- Experienced user of a MED-EL SONNET audio processor (≥ 6 months)
- Post-lingual onset of bilateral severe to profound sensory-neural hearing loss
- Unilateral CI user
- A minimum of 10 active electrodes
- A minimum of 40% speech recognition in the Freiburg Monosyllables test in quiet at 65 dB sound pressure level (SPL; at the last time tested)
- Fluent in German (the language of the test centre)
- Signed and dated Informed Consent Form before the start of any study-specific procedure.
Exclusion
- Lack of compliance with any inclusion criteria
- CI user with contralateral hearing equal to or better than 60 dB (PTA measured at 500, 1000, and 2000Hz)
- User with electric-acoustic stimulation (EAS; user of an EAS audio processor)
- Implanted with C40X and C40C
- Implanted with an Auditory Brainstem Implant or Split electrode array
- Known allergic reactions to components of the investigational medical device
- Unstable psychological status
- Anything that, in the opinion of the Investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study
Key Trial Info
Start Date :
April 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 5 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03861442
Start Date
April 1 2019
End Date
March 5 2020
Last Update
June 5 2024
Active Locations (1)
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1
Klinik und Poliklinik für Hals-, Nasen- und Ohrenkrankheiten, plastische und ästhetische Operationen
Würzburg, Bavaria, Germany, 97080