Non-significant Risk Study of a Cochlear Implant Headpiece
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Advanced Bionics
- Enrollment
- 101
- Locations
- 2
- Primary Endpoint
- Subjective Report of Headpiece Comfort and Retention
Study Overview
Brief Summary
This study aims to evaluate a cochlear implant headpiece.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Subjective Report of Headpiece Comfort and Retention
Time Frame: 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 Outcomes
No secondary outcomes reported