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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

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ClinicalTrials.gov Identifier: NCT03327194
Recruitment Status : Recruiting
First Posted : October 31, 2017
Last Update Posted : February 15, 2018
Sponsor:
Collaborator:
MED-EL Elektromedizinische Geräte GmbH
Information provided by (Responsible Party):
Queen Fabiola Children's University Hospital

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.


Condition or disease Intervention/treatment Phase
Conductive Hearing Loss Single Sided Deafness Device: ADHEAR Audio Processor Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Monocentric prospective interventional single-subject design
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Subjective Satisfaction and Audiological Benefit With ADHEAR Audio Processor and ADHEAR Adhesive Adapter in Children
Actual Study Start Date : January 31, 2018
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ADHEAR Audio processor Device: 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.





Primary Outcome Measures :
  1. Maximal decibels gain measured by Audiological basic tests [ Time Frame: Week 3 ]
  2. Maximal decibels gain measured by speech reception threshold in quiet [ Time Frame: Week 3 ]

Secondary Outcome Measures :
  1. Comparison of maximal decibels gain measured by Audiological basic tests between ADHEAR Audio Processor and Cochlear bone anchored hearing aid. [ Time Frame: Day 0 ]
  2. Comparison of maximal decibels gain measured by speech reception threshold in quiet between ADHEAR Audio Processor and Cochlear bone anchored hearing aid [ Time Frame: Day 0 ]
  3. Change from baseline in Quality of Life measured by the SSQ12 questionnaire [ Time Frame: week 3 ]
  4. Change from baseline in Quality of Life measured by the SSQ12 questionnaire [ Time Frame: month 3 ]
  5. Change from baseline in Quality of Life measured by the SSQ12 questionnaire [ Time Frame: month 6 ]
  6. Change from baseline in Quality of Life measured by the SSQ12 questionnaire [ Time Frame: month 12 ]
  7. Change from baseline in patient and parents satisfaction measured by the ADHEAR Questionnaire [ Time Frame: week 3 ]
  8. Change from baseline in patient and parents satisfaction measured by the ADHEAR Questionnaire [ Time Frame: month 3 ]
  9. Change from baseline in patient and parents satisfaction measured by the ADHEAR Questionnaire [ Time Frame: month 6 ]
  10. Change from baseline in patient and parents satisfaction measured by the ADHEAR Questionnaire [ Time Frame: month 12 ]
  11. Number of subjects who discontinue study device utilization due to any AE or dissatisfaction [ Time Frame: Year 1 ]
  12. Average time of daily use of ADHEAR System [ Time Frame: week 3 ]
    Adherence reported by patient on a diary card.

  13. Incidence of device-emergent adverse event. [ Time Frame: Up to 1 year after start of study device utilization ]
    Number of participants with device-related adverse events as assessed by CTCAE v4.0



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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03327194


Contacts
Contact: Amélia Favoreel 0032 2 477 24 71 amelia.favoreel@huderf.be
Contact: Jenne Keyen 0032 2 477 24 71 jenne.keyen@huderf.be

Locations
Belgium
Hôpital Universitaire Des Enfants Reine Fabiola Recruiting
Brussel, Belgium, 1020
Contact: Amelia Favoreel    0032 2 477 24 71    amelia.favoreel@huderf.be   
Sponsors and Collaborators
Queen Fabiola Children's University Hospital
MED-EL Elektromedizinische Geräte GmbH
Investigators
Principal Investigator: Anne-Laure Mansbach, MD PhD Queen Fabiola Children's University Hospital

Responsible Party: Queen Fabiola Children's University Hospital
ClinicalTrials.gov Identifier: NCT03327194     History of Changes
Other Study ID Numbers: P2017/ORL/ADHEAR
First Posted: October 31, 2017    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Loss, Conductive
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms