Non-significant Risk Study of a Cochlear Implant Headpiece
NCT ID: NCT05488535
Last Updated: 2023-11-14
Study Results
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View full resultsBasic Information
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COMPLETED
101 participants
INTERVENTIONAL
2019-02-28
2020-02-22
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
TREATMENT
NONE
Study Groups
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Non-significant risk study of a cochlear implant headpiece
This arm aims to evaluate a cochlear implant headpiece.
cochlear implant headpiece
investigational cochlear implant headpiece
Interventions
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cochlear implant headpiece
investigational cochlear implant headpiece
Eligibility Criteria
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Inclusion Criteria
* Fluent in English, French, or Spanish or capable of communication with a caregiver who is providing consent.
* Adult or child implanted with a commercially available Advanced Bionics cochlear implant. Children and adult participants are included to ensure device retention is appropriate for all implant populations.
* Have (or caregivers have) the cognitive and functional capability to comply with all directions during the study
* Be able to remove their own headpiece
* Have (or caregivers have) the cognitive and functional capability to complete the questionnaire required for the study
* Capable (or caregivers are capable) of reading and understanding patient information materials and giving written informed consent
Exclusion Criteria
ALL
No
Sponsors
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Advanced Bionics
INDUSTRY
Responsible Party
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Locations
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Advanced Bionics
Valencia, California, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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20190256
Identifier Type: -
Identifier Source: org_study_id
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