Trial Outcomes & Findings for Non-significant Risk Study of a Cochlear Implant Headpiece (NCT NCT05488535)
NCT ID: NCT05488535
Last Updated: 2023-11-14
Results Overview
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)
COMPLETED
101 participants
Assessed every two months from month 2 to month 12, values at study close out (month 12) reported.
2023-11-14
Participant Flow
Participant milestones
| Measure |
Overall Study
Participants eligible to participate in this study were evaluated according to the inclusion requirements for the study. Informed consent was obtained before any study-specific tests or procedures are conducted. An individual was considered to be enrolled as a study participant only after the informed consent document was signed and dated. Each participant was assigned a unique identifier at the time of enrollment. There was only one group of participants for the overall study.
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|---|---|
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Overall Study
STARTED
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101
|
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Overall Study
COMPLETED
|
96
|
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Overall Study
NOT COMPLETED
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5
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Non-significant Risk Study of a Cochlear Implant Headpiece
n=101 Participants
This arm aims to evaluate a cochlear implant headpiece.
cochlear implant headpiece: investigational cochlear implant headpiece
|
|---|---|
|
Age, Categorical
<=18 years
|
6 Participants
n=101 Participants
|
|
Age, Categorical
Between 18 and 65 years
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54 Participants
n=101 Participants
|
|
Age, Categorical
>=65 years
|
41 Participants
n=101 Participants
|
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Age, Continuous
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62 years
n=101 Participants
|
|
Sex: Female, Male
Female
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31 Participants
n=101 Participants
|
|
Sex: Female, Male
Male
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70 Participants
n=101 Participants
|
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Region of Enrollment
United States
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101 participants
n=101 Participants
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PRIMARY outcome
Timeframe: 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).
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)
Outcome measures
| Measure |
Non-significant Risk Study of a Cochlear Implant Headpiece
n=72 Participants
This arm aims to evaluate a cochlear implant headpiece.
cochlear implant headpiece: investigational cochlear implant headpiece
|
|---|---|
|
Subjective Report of Headpiece Comfort and Retention
Favorable Retention Rating
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65 Participants
|
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Subjective Report of Headpiece Comfort and Retention
Favorable Comfort Rating
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70 Participants
|
Adverse Events
Non-significant Risk Study of a Cochlear Implant Headpiece
Serious adverse events
| Measure |
Non-significant Risk Study of a Cochlear Implant Headpiece
n=101 participants at risk
This arm aims to evaluate a cochlear implant headpiece.
cochlear implant headpiece: investigational cochlear implant headpiece
|
|---|---|
|
Surgical and medical procedures
Skin Flap Thinning Procedure
|
2.0%
2/101 • Number of events 2 • Issues were reported either by way of direct communications between the trial participants and investigators (verbal, email, phone, etc.) during the active phase of the study (11 months total).
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Other adverse events
| Measure |
Non-significant Risk Study of a Cochlear Implant Headpiece
n=101 participants at risk
This arm aims to evaluate a cochlear implant headpiece.
cochlear implant headpiece: investigational cochlear implant headpiece
|
|---|---|
|
Product Issues
Device Temperature
|
0.99%
1/101 • Number of events 1 • Issues were reported either by way of direct communications between the trial participants and investigators (verbal, email, phone, etc.) during the active phase of the study (11 months total).
|
|
Ear and labyrinth disorders
Dizziness
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0.99%
1/101 • Number of events 1 • Issues were reported either by way of direct communications between the trial participants and investigators (verbal, email, phone, etc.) during the active phase of the study (11 months total).
|
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General disorders
Headache
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2.0%
2/101 • Number of events 2 • Issues were reported either by way of direct communications between the trial participants and investigators (verbal, email, phone, etc.) during the active phase of the study (11 months total).
|
|
Skin and subcutaneous tissue disorders
Skin Redness
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0.99%
1/101 • Number of events 1 • Issues were reported either by way of direct communications between the trial participants and investigators (verbal, email, phone, etc.) during the active phase of the study (11 months total).
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place