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

Sponsored by Queen Fabiola Children's University Hospital

About this trial

Last updated 8 years ago

Study ID

P2017/ORL/ADHEAR

Status

Unknown

Type

Interventional

Phase

N/A

Placebo

No

Accepting

5 to 17 Years
All Sexes

Trial Timing

Ended 6 years ago

What is this trial about?

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.

What are the participation requirements?

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