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

Not Applicable

• Conditions: Conductive Hearing Loss; Single Sided Deafness
• Interventions: Device: ADHEAR Audio Processor

• Registration Number: NCT03327194
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-25
• Study First Submitted QC: 2017-10-30
• Study First Posted: 2017-10-31
• Study Start: 2018-01-31
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-14
• Last Update Posted: 2018-02-15
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ADHEAR Audio processor	ADHEAR Audio Processor	-

Primary Outcome Measures

Name	Time	Method
Maximal decibels gain measured by Audiological basic tests	Week 3
Maximal decibels gain measured by speech reception threshold in quiet	Week 3

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Quality of Life measured by the SSQ12 questionnaire	month 12
Comparison of maximal decibels gain measured by Audiological basic tests between ADHEAR Audio Processor and Cochlear bone anchored hearing aid.	Day 0
Comparison of maximal decibels gain measured by speech reception threshold in quiet between ADHEAR Audio Processor and Cochlear bone anchored hearing aid	Day 0
Change from baseline in patient and parents satisfaction measured by the ADHEAR Questionnaire	month 12
Incidence of device-emergent adverse event.	Up to 1 year after start of study device utilization	Number of participants with device-related adverse events as assessed by CTCAE v4.0
Number of subjects who discontinue study device utilization due to any AE or dissatisfaction	Year 1
Average time of daily use of ADHEAR System	week 3	Adherence reported by patient on a diary card.

Trial Locations

Locations (1)

Hôpital Universitaire Des Enfants Reine Fabiola; 🇧🇪 Brussel, Belgium