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

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Brief Title

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

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.
    



Study Type

Interventional


Primary Outcome

Maximal decibels gain measured by Audiological basic tests

Secondary Outcome

 Comparison of maximal decibels gain measured by Audiological basic tests between ADHEAR Audio Processor and Cochlear bone anchored hearing aid.

Condition

Conductive Hearing Loss

Intervention

ADHEAR Audio Processor

Study Arms / Comparison Groups

 ADHEAR Audio processor
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

10

Start Date

January 31, 2018

Completion Date

December 1, 2019

Primary Completion Date

December 1, 2019

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
      

Gender

All

Ages

5 Years - 17 Years

Accepts Healthy Volunteers

No

Contacts

Anne-Laure Mansbach, MD PhD, 0032 2 477 24 71, [email protected]

Location Countries

Belgium

Location Countries

Belgium

Administrative Informations


NCT ID

NCT03327194

Organization ID

P2017/ORL/ADHEAR


Responsible Party

Sponsor

Study Sponsor

Queen Fabiola Children's University Hospital

Collaborators

 MED-EL Elektromedizinische Geräte GmbH

Study Sponsor

Anne-Laure Mansbach, MD PhD, Principal Investigator, Queen Fabiola Children's University Hospital


Verification Date

February 2018