Hearing Loss, Sensorineural Hearing Loss
Conditions
Keywords
cochlear implant
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.
Interventions
DEVICEcochlear implant headpiece
investigational cochlear implant headpiece
Sponsors
Advanced Bionics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Non-significant Risk Study of a Cochlear Implant Headpiece This arm aims to evaluate a cochlear implant headpiece.
cochlear implant headpiece: investigational cochlear implant headpiece | 101 |
| Total | 101 |
Baseline characteristics
| Characteristic | Non-significant Risk Study of a Cochlear Implant Headpiece | — |
|---|---|---|
| Age, Categorical <=18 years | 6 Participants | — |
| Age, Categorical >=65 years | 41 Participants | — |
| Age, Categorical Between 18 and 65 years | 54 Participants | — |
| Age, Continuous | 62 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 101 participants | — |
| Sex: Female, Male Female | 31 Participants | — |
| Sex: Female, Male Male | 70 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 101 |
| other Total, other adverse events | 5 / 101 |
| serious Total, serious adverse events | 2 / 101 |
Outcome results
Primary
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: 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)
Time frame: Assessed every two months from month 2 to month 12, values at study close out (month 12) reported.
Population: Subject count at baseline (n=100, includes all subjects enrolled) differ from the overall number of participants analyzed at study close-out (n=72, includes all subjects who were wearing headpiece at the end of the study and who completed final questionnaire).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Non-significant Risk Study of a Cochlear Implant Headpiece | Subjective Report of Headpiece Comfort and Retention | Favorable Retention Rating | 65 Participants |
| Non-significant Risk Study of a Cochlear Implant Headpiece | Subjective Report of Headpiece Comfort and Retention | Favorable Comfort Rating | 70 Participants |