Non-significant Risk Study of a Cochlear Implant Headpiece

Completed

Conditions studied: Hearing Loss, Sensorineural Hearing Loss

In brief

This study aims to evaluate a cochlear implant headpiece.

Key facts

Study ID

NCT05488535

Run by

Advanced Bionics

People needed

101

Starts

2019-02-28

Expected to finish

2020-02-22

Last updated by the study team

2023-11-14

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pre- or post-lingually deafened.
• 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

You may not qualify if…

• Have any significant medical condition that, in the opinion of any of the investigators, is likely to interfere with study procedures or likely to confound evaluation of study data.

Where it is running

• Advanced Bionics — Valencia, California, United States

Full record on ClinicalTrials.gov

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