Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2024-12-16
2025-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SONNET 3 (EAS)
Participants complete a take-home trial using SONNET 3 (EAS) audio processor
Audio processor
MED-EL SONNET 3 (EAS) audio processor
Interventions
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Audio processor
MED-EL SONNET 3 (EAS) audio processor
Eligibility Criteria
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Inclusion Criteria
* ≥ 12 months since activation of the MED-EL audio processor
* Consistently using a SONNET (EAS) or SONNET 2 (EAS) Audio Processor
* Ability to complete all study procedures
* Participant and parental (if applicable) commitment to comply with all study procedures for the duration of the study
Exclusion Criteria
* Unable to provide reliable feedback during cochlear implant programming
* Skin or scalp condition precluding use of the study device
* Unrealistic participant or parent (if applicable) motivation or expectations
* Participants without a stable fitting map at enrollment e.g., due to changes in hearing, global health status, etc.
7 Years
ALL
No
Sponsors
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Med-El Corporation
INDUSTRY
Responsible Party
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Locations
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University of North Carolina
Chapel Hill, North Carolina, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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G240188
Identifier Type: -
Identifier Source: org_study_id