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| Name | Class |
|---|---|
| MED-EL Elektromedizinische Geräte GmbH | UNKNOWN |
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A hearing loss affects the quality of life and the natural development of children.
The new generation of hearing devices provides a huge number of options to them. These new hearing aids are often aesthetically acceptable, less invasive and user-friendly.
The ADHEAR Non-Implantable Bone Conduction Hearing System is connected directly to the skin with a special adhesive adapter. The device transmits the sound to the mastoid by vibrating on the skull and stimulates the inner ear without any previous surgery.
The objective of this study is to evaluate of the audiological benefit and subjective satisfaction of ADHEAR Audio Processor with Adhesive attachment in a group of children suffering from conductive hearing loss and/or single sided deafness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADHEAR Audio processor | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADHEAR Audio Processor | Device | ADHEAR Audio Processoris a non-invasive bone conduction hearing device which is retained on the patient's head with an adhesive adapter that is placed behind the auricle. The ADHEAR Audio Processor transmits sounds to the mastoid by vibrating on the skull and stimulates the inner ear without any previous surgery. ADHEAR Audio Processor is classified as a Class lla medical device and ADHEAR Adhesive Adapter is classified as a Class I medical device. The ADHEAR Audio Processor has the CE mark. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximal decibels gain measured by Audiological basic tests | Week 3 | |
| Maximal decibels gain measured by speech reception threshold in quiet | Week 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of maximal decibels gain measured by Audiological basic tests between ADHEAR Audio Processor and Cochlear bone anchored hearing aid. | Day 0 | |
| Comparison of maximal decibels gain measured by speech reception threshold in quiet between ADHEAR Audio Processor and Cochlear bone anchored hearing aid |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amélia Favoreel | Contact | 0032 2 477 24 71 | amelia.favoreel@huderf.be | |
| Jenne Keyen | Contact | 0032 2 477 24 71 | jenne.keyen@huderf.be |
| Name | Affiliation | Role |
|---|---|---|
| Anne-Laure Mansbach, MD PhD | Queen Fabiola Children's University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Universitaire Des Enfants Reine Fabiola | Recruiting | Brussels | 1020 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31689608 | Derived | Favoreel A, Heuninck E, Mansbach AL. Audiological benefit and subjective satisfaction of children with the ADHEAR audio processor and adhesive adapter. Int J Pediatr Otorhinolaryngol. 2020 Feb;129:109729. doi: 10.1016/j.ijporl.2019.109729. Epub 2019 Oct 15. |
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Monocentric prospective interventional single-subject design
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|
| Day 0 |
| Change from baseline in Quality of Life measured by the SSQ12 questionnaire | week 3 |
| Change from baseline in Quality of Life measured by the SSQ12 questionnaire | month 3 |
| Change from baseline in Quality of Life measured by the SSQ12 questionnaire | month 6 |
| Change from baseline in Quality of Life measured by the SSQ12 questionnaire | month 12 |
| Change from baseline in patient and parents satisfaction measured by the ADHEAR Questionnaire | week 3 |
| Change from baseline in patient and parents satisfaction measured by the ADHEAR Questionnaire | month 3 |
| Change from baseline in patient and parents satisfaction measured by the ADHEAR Questionnaire | month 6 |
| Change from baseline in patient and parents satisfaction measured by the ADHEAR Questionnaire | month 12 |
| Number of subjects who discontinue study device utilization due to any AE or dissatisfaction | Year 1 |
| Average time of daily use of ADHEAR System | Adherence reported by patient on a diary card. | week 3 |
| Incidence of device-emergent adverse event. | Number of participants with device-related adverse events as assessed by CTCAE v4.0 | Up to 1 year after start of study device utilization |
| ID | Term |
|---|---|
| D006314 | Hearing Loss, Conductive |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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