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

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

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 Overview

• Status: Unknown
• Conditions: Conductive Hearing Loss; Single Sided Deafness
• Intervention / Treatment: Device: ADHEAR Audio Processor

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amelia Favoreel; Phone Number: 0032 2 477 24 71; Email: amelia.favoreel@huderf.be
• Study Contact Backup: Name: Jenne Keyen; Phone Number: 0032 2 477 24 71; Email: jenne.keyen@huderf.be

Study Locations

• Belgium
  • Brussel, Belgium, 1020
    • Recruiting
    • Hôpital Universitaire des Enfants Reine Fabiola
    • Contact: Amelia Favoreel; Phone Number: 0032 2 477 24 71; Email: amelia.favoreel@huderf.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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 Quality of Life measured by the SSQ12 questionnaire		week 3
Change from baseline in Quality of Life measured by the SSQ12 questionnaire		month 3
Change from baseline in Quality of Life measured by the SSQ12 questionnaire		month 6
Change from baseline in Quality of Life measured by the SSQ12 questionnaire		month 12
Change from baseline in patient and parents satisfaction measured by the ADHEAR Questionnaire		week 3
Change from baseline in patient and parents satisfaction measured by the ADHEAR Questionnaire		month 3
Change from baseline in patient and parents satisfaction measured by the ADHEAR Questionnaire		month 6
Change from baseline in patient and parents satisfaction measured by the ADHEAR Questionnaire		month 12
Number of subjects who discontinue study device utilization due to any AE or dissatisfaction		Year 1
Average time of daily use of ADHEAR System	Adherence reported by patient on a diary card.	week 3
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

Collaborators and Investigators

• Sponsor: Queen Fabiola Children's University Hospital
• Collaborators: MED-EL Elektromedizinische Geräte GmbH
• Investigators: Principal Investigator: Anne-Laure Mansbach, MD PhD, Queen Fabiola Children's University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2018
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: October 25, 2017
• First Submitted That Met QC Criteria: October 30, 2017
• First Posted (Actual): October 31, 2017

Study Record Updates

• Last Update Posted (Actual): February 15, 2018
• Last Update Submitted That Met QC Criteria: February 14, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Conductive
• Other Study ID Numbers: P2017/ORL/ADHEAR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No