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

Conductive Hearing Loss Clinical Trial

Official title:

Subjective Satisfaction and Audiological Benefit With ADHEAR Audio Processor and ADHEAR Adhesive Adapter in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03327194
• Other study ID #: P2017/ORL/ADHEAR
• Status: Recruiting
• Phase: N/A
• First received: October 25, 2017
• Last updated: February 14, 2018
• Start date: January 31, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: February 2018
• Source: Queen Fabiola Children's University Hospital
• Contact: Amélia Favoreel
• Phone: 0032 2 477 24 71
• Email: amelia.favoreel[@]huderf.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Conductive Hearing Loss
• Deafness
• Hearing Loss
• Hearing Loss, Conductive
• Single Sided Deafness

Intervention

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.

Locations

Country	Name	City	State
Belgium	Hôpital Universitaire Des Enfants Reine Fabiola	Brussel

Sponsors (2)

Lead Sponsor	Collaborator
Queen Fabiola Children's University Hospital	MED-EL Elektromedizinische Geräte GmbH

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal decibels gain measured by Audiological basic tests		Week 3
Primary	Maximal decibels gain measured by speech reception threshold in quiet		Week 3
Secondary	Comparison of maximal decibels gain measured by Audiological basic tests between ADHEAR Audio Processor and Cochlear bone anchored hearing aid.		Day 0
Secondary	Comparison of maximal decibels gain measured by speech reception threshold in quiet between ADHEAR Audio Processor and Cochlear bone anchored hearing aid		Day 0
Secondary	Change from baseline in Quality of Life measured by the SSQ12 questionnaire		week 3
Secondary	Change from baseline in Quality of Life measured by the SSQ12 questionnaire		month 3
Secondary	Change from baseline in Quality of Life measured by the SSQ12 questionnaire		month 6
Secondary	Change from baseline in Quality of Life measured by the SSQ12 questionnaire		month 12
Secondary	Change from baseline in patient and parents satisfaction measured by the ADHEAR Questionnaire		week 3
Secondary	Change from baseline in patient and parents satisfaction measured by the ADHEAR Questionnaire		month 3
Secondary	Change from baseline in patient and parents satisfaction measured by the ADHEAR Questionnaire		month 6
Secondary	Change from baseline in patient and parents satisfaction measured by the ADHEAR Questionnaire		month 12
Secondary	Number of subjects who discontinue study device utilization due to any AE or dissatisfaction		Year 1
Secondary	Average time of daily use of ADHEAR System	Adherence reported by patient on a diary card.	week 3
Secondary	Incidence of device-emergent adverse event.	Number of participants with device-related adverse events as assessed by CTCAE v4.0	Up to 1 year after start of study device utilization