Evaluation of Sound Processor for a Transcutaneous System
NCT ID: NCT03374787
Last Updated: 2025-03-17
Study Results
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View full resultsBasic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2017-11-15
2018-11-22
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
DEVICE_FEASIBILITY
NONE
Study Groups
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Fusion sound processor
The sound processor picks up the sound and transfer it to the implant that convert the sound to vibrations that are transmitted to the inner ear.
Fusion Sound Processor
Sound Processor
Interventions
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Fusion Sound Processor
Sound Processor
Eligibility Criteria
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Inclusion Criteria
* Subjects that have completed one year follow up in Osseofon BCI (Bone Conduction Implant) study
* Subjects available for 6 months study procedures without affecting the follow ups in the Osseofon BCI study
* Active user of the BCI SP
Exclusion Criteria
* Unsuitable as judged by the principle investigator or the sub-investigator
ALL
No
Sponsors
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Sahlgrenska University Hospital
OTHER
Oticon Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Måns Eeg Olofsson, MD
Role: PRINCIPAL_INVESTIGATOR
Sahlgrenska University Hospital
Locations
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ENT departement, Sahlgrenska University Hospital
Gothenburg, , Sweden
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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C58
Identifier Type: -
Identifier Source: org_study_id
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