Non-significant Risk Study of a Cochlear Implant Headpiece

Non-significant Risk Study of a Cochlear Implant Headpiece

This study aims to evaluate a cochlear implant headpiece.

The headpiece and magnet are expected to provide acceptable comfort and retention for existing cochlear implant users. In this study participants will report on their experience with the investigational headpiece during daily life.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.