Use of ADHEAR, a Non-Implantable Bone Conduction Hearing System, in Children With Single Sided Deafness and/or Conductive Hearing Loss

Study Overview
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Brief Summary
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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.

Official Title
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Subjective Satisfaction and Audiological Benefit With ADHEAR Audio Processor and ADHEAR Adhesive Adapter in Children

Conditions
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Conductive Hearing Loss, Single Sided Deafness

Intervention / Treatment
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* Device: ADHEAR Audio Processor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unilateral and/or bilateral CHL (e. g. BC-thresholds <25dB HL) Ability to perform all tests required for the study Signed, and dated informed consent by parents and children where applicable Exclusion Criteria: intolerant of the materials patient with a skin or scalp condition that may preclude the attachment of the adhesive plaster fluctuation of hearing loss over a two year period of 15dB in either direction retrocochlear, or central auditory disorders any physical, psychological, or emotional disorder that would interfere with the ability to perform on test and rehabilitation procedures

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Monocentric prospective interventional single-subject design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ADHEAR Audio processor<br> | Device: ADHEAR Audio Processor<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 |