Use of ADHEAR, a Non-Implantable Bone Conduction Hearing System, in Children With Single Sided Deafness and/or Conductive Hearing Loss
NCT ID: NCT03327194
Last Updated: 2018-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
10 participants
INTERVENTIONAL
2018-01-31
2019-12-01
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ADHEAR Audio processor
ADHEAR Audio Processor
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.
Interventions
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ADHEAR Audio Processor
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.
Eligibility Criteria
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Inclusion Criteria
* Ability to perform all tests required for the study
* Signed, and dated informed consent by parents and children where applicable
Exclusion Criteria
* 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
5 Years
17 Years
ALL
No
Sponsors
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MED-EL Elektromedizinische Geräte GmbH
UNKNOWN
Queen Fabiola Children's University Hospital
OTHER
Responsible Party
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Principal Investigators
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Anne-Laure Mansbach, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Queen Fabiola Children's University Hospital
Locations
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Hôpital Universitaire Des Enfants Reine Fabiola
Brussels, , Belgium
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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P2017/ORL/ADHEAR
Identifier Type: -
Identifier Source: org_study_id
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