Non-significant Risk Study of a Cochlear Implant Headpiece

Study Overview
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Brief Summary
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This study aims to evaluate a cochlear implant headpiece.

Detailed Description
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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.

Official Title
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Non-significant Risk Study of a Cochlear Implant Headpiece

Conditions
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Sensorineural Hearing Loss, Hearing Loss

Intervention / Treatment
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* Device: cochlear implant headpiece


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-significant risk study of a cochlear implant headpiece<br>This arm aims to evaluate a cochlear implant headpiece. | Device: cochlear implant headpiece<br>* investigational cochlear implant headpiece<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Report of Headpiece Comfort and Retention | 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: Rate the retention of your personal/investigational headpiece (Very acceptable, Acceptable, No Opinion, Unacceptable, Very Unacceptable) Rate the comfort of your personal headpiece (Very acceptable, Acceptable, No Opinion, Unacceptable, Very Unacceptable) | Assessed every two months from month 2 to month 12, values at study close out (month 12) reported. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cochlear implant