Non-significant Risk Study of a Cochlear Implant Headpiece

Completed

Detailed Description: 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.

Recruitment & Eligibility

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.

Primary Outcome Measures

Name	Time	Method
Subjective Report of Headpiece Comfort and Retention	Assessed every two months from month 2 to month 12, values at study close out (month 12) reported.	Comfort and subjective retention of the headpiece were rated via questionnaire for baseline headpiece and investigational headpiece acute and chronic use. Subjects were provided with ratings questionnaires and asked to chronically evaluate the headpiece and associated magnet for comfort and retention every two months. Results are presented as total count of participants who rated retention and comfort as favorable ("no opinion," "acceptable," or "very acceptable") at study close out. The baseline/investigational headpiece questionnaires included 2 questions: 1. Rate the retention of your personal/investigational headpiece (Very acceptable, Acceptable, No Opinion, Unacceptable, Very Unacceptable) 2. Rate the comfort of your personal headpiece (Very acceptable, Acceptable, No Opinion, Unacceptable, Very Unacceptable)

Secondary Outcome Measures