Clinical trial NCT03327194: Use of ADHEAR, a Non-Implantable Bone Conduction Hearing System, in Children With Single Sided Deafness and/or Conductive Hearing Loss
Official title: Subjective Satisfaction and Audiological Benefit With ADHEAR Audio Processor and ADHEAR Adhesive Adapter in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Conductive Hearing Loss
Single Sided Deafness
Lead sponsor: Queen Fabiola Children's University Hospital
Sponsor class: OTHER
Collaborators: name: MED-EL Elektromedizinische Geräte GmbH
First posted: 2017-10-31
Enrollment: 10
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Monocentric prospective interventional single-subject design
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Maximal decibels gain measured by Audiological basic tests
timeFrame: Week 3
measure: Maximal decibels gain measured by speech reception threshold in quiet
timeFrame: Week 3
Secondary outcomes:
measure: Comparison of maximal decibels gain measured by Audiological basic tests between ADHEAR Audio Processor and Cochlear bone anchored hearing aid.
timeFrame: Day 0
measure: Comparison of maximal decibels gain measured by speech reception threshold in quiet between ADHEAR Audio Processor and Cochlear bone anchored hearing aid
timeFrame: Day 0
measure: Change from baseline in Quality of Life measured by the SSQ12 questionnaire
timeFrame: week 3
measure: Change from baseline in Quality of Life measured by the SSQ12 questionnaire
timeFrame: month 3
measure: Change from baseline in Quality of Life measured by the SSQ12 questionnaire
timeFrame: month 6
measure: Change from baseline in Quality of Life measured by the SSQ12 questionnaire
timeFrame: month 12
measure: Change from baseline in patient and parents satisfaction measured by the ADHEAR Questionnaire
timeFrame: week 3
measure: Change from baseline in patient and parents satisfaction measured by the ADHEAR Questionnaire
timeFrame: month 3
measure: Change from baseline in patient and parents satisfaction measured by the ADHEAR Questionnaire
timeFrame: month 6
measure: Change from baseline in patient and parents satisfaction measured by the ADHEAR Questionnaire
timeFrame: month 12
measure: Number of subjects who discontinue study device utilization due to any AE or dissatisfaction
timeFrame: Year 1
measure: Average time of daily use of ADHEAR System
timeFrame: week 3
measure: Incidence of device-emergent adverse event.
timeFrame: Up to 1 year after start of study device utilization
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Hôpital Universitaire Des Enfants Reine Fabiola
Study officials:
affiliation: Queen Fabiola Children's University Hospital
name: Anne-Laure Mansbach, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.