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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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.
Hôpital Universitaire Des Enfants Reine Fabiola
Brussels, Belgium
RECRUITINGMaximal decibels gain measured by Audiological basic tests
Time frame: Week 3
Maximal decibels gain measured by speech reception threshold in quiet
Time frame: Week 3
Comparison of maximal decibels gain measured by Audiological basic tests between ADHEAR Audio Processor and Cochlear bone anchored hearing aid.
Time frame: Day 0
Comparison of maximal decibels gain measured by speech reception threshold in quiet between ADHEAR Audio Processor and Cochlear bone anchored hearing aid
Time frame: Day 0
Change from baseline in Quality of Life measured by the SSQ12 questionnaire
Time frame: week 3
Change from baseline in Quality of Life measured by the SSQ12 questionnaire
Time frame: month 3
Change from baseline in Quality of Life measured by the SSQ12 questionnaire
Time frame: month 6
Change from baseline in Quality of Life measured by the SSQ12 questionnaire
Time frame: month 12
Change from baseline in patient and parents satisfaction measured by the ADHEAR Questionnaire
Time frame: week 3
Change from baseline in patient and parents satisfaction measured by the ADHEAR Questionnaire
Time frame: month 3
Change from baseline in patient and parents satisfaction measured by the ADHEAR Questionnaire
Time frame: month 6
Change from baseline in patient and parents satisfaction measured by the ADHEAR Questionnaire
Time frame: month 12
Number of subjects who discontinue study device utilization due to any AE or dissatisfaction
Time frame: Year 1
Average time of daily use of ADHEAR System
Adherence reported by patient on a diary card.
Time frame: week 3
Incidence of device-emergent adverse event.
Number of participants with device-related adverse events as assessed by CTCAE v4.0
Time frame: Up to 1 year after start of study device utilization
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