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This study aims to evaluate a cochlear implant headpiece.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-significant risk study of a cochlear implant headpiece | Experimental | This arm aims to evaluate a cochlear implant headpiece. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cochlear implant headpiece | Device | investigational cochlear implant headpiece |
|
| 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:
| Assessed every two months from month 2 to month 12, values at study close out (month 12) reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Bionics | Valencia | California | 91355 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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:
| 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). | Posted | Count of Participants | Participants | Assessed every two months from month 2 to month 12, values at study close out (month 12) reported. |
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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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin Flap Thinning Procedure | Surgical and medical procedures | Non-systematic Assessment | The investigational headpiece and magnet were not sufficient in providing acceptable and comfortable retention. Subject had skin flap thinning procedure to ensure headpiece retention was acceptable. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Device Temperature | Product Issues | Non-systematic Assessment | Report of investigational device being hot to touch and unwearable. Use of the device was discontinued and returned for analysis, no issue found. No further issues were reported. The issue considered resolved. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emily Cardenas, Au.D. | Advanced Bionics | 16616785405 | Emily.Cardenas@advancedbionics.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 25, 2019 | Jul 31, 2023 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006319 | Hearing Loss, Sensorineural |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | 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 |
|
|
| 0 |
| 101 |
| 2 |
| 101 |
| 5 |
| 101 |
|
|
| Dizziness | Ear and labyrinth disorders | Non-systematic Assessment | Subject reported dizziness when using the investigation device while wearing a headband. After removal of the headband, subject reported feeling dizzy. Subject returned to personal device with a headband. No additional issues were reported. |
|
| Headache | General disorders | Non-systematic Assessment | Subject reported experiencing headaches for several months using the investigational device. Subject stopped wearing the investigational device and returned to personal device. Subject reported headaches resolved. |
|
| Skin Redness | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Subject self-reported redness of the skin from the investigational device. Site was checked by their audiologist. No redness was reported. The subject continued using the investigational device without incident. |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |