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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

Primary Purpose

Conductive Hearing Loss, Single Sided Deafness

Status

Unknown status

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

ADHEAR Audio Processor

About this trial

This is an interventional treatment trial for Conductive Hearing Loss

Eligibility Criteria

5 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hôpital Universitaire Des Enfants Reine FabiolaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ADHEAR Audio processor

Arm Description

Outcomes

Primary Outcome Measures

Maximal decibels gain measured by Audiological basic tests

Maximal decibels gain measured by speech reception threshold in quiet

Secondary Outcome Measures

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

Comparison of maximal decibels gain measured by speech reception threshold in quiet between ADHEAR Audio Processor and Cochlear bone anchored hearing aid

Change from baseline in Quality of Life measured by the SSQ12 questionnaire

Change from baseline in patient and parents satisfaction measured by the ADHEAR Questionnaire

Number of subjects who discontinue study device utilization due to any AE or dissatisfaction

Average time of daily use of ADHEAR System

Adherence reported by patient on a diary card.

Incidence of device-emergent adverse event.

Number of participants with device-related adverse events as assessed by CTCAE v4.0

Full Information

NCT ID

NCT03327194

First Posted

October 25, 2017

Last Updated

February 14, 2018

Sponsor

Queen Fabiola Children's University Hospital

Collaborators

MED-EL Elektromedizinische Geräte GmbH

1. Study Identification

Unique Protocol Identification Number

NCT03327194

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Unknown status

Study Start Date

January 31, 2018 (Actual)

Primary Completion Date

December 1, 2019 (Anticipated)

Study Completion Date

December 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Queen Fabiola Children's University Hospital

Collaborators

MED-EL Elektromedizinische Geräte GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Conductive Hearing Loss, Single Sided Deafness

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Monocentric prospective interventional single-subject design

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ADHEAR Audio processor

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

ADHEAR Audio Processor

Intervention Description

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 Measure Information:

Title

Maximal decibels gain measured by Audiological basic tests

Time Frame

Week 3

Title

Maximal decibels gain measured by speech reception threshold in quiet

Time Frame

Week 3

Secondary Outcome Measure Information:

Title

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

Time Frame

Day 0

Title

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

Title

Change from baseline in Quality of Life measured by the SSQ12 questionnaire

Time Frame

week 3

Title

Change from baseline in Quality of Life measured by the SSQ12 questionnaire

Time Frame

month 3

Title

Change from baseline in Quality of Life measured by the SSQ12 questionnaire

Time Frame

month 6

Title

Change from baseline in Quality of Life measured by the SSQ12 questionnaire

Time Frame

month 12

Title

Change from baseline in patient and parents satisfaction measured by the ADHEAR Questionnaire

Time Frame

week 3

Title

Change from baseline in patient and parents satisfaction measured by the ADHEAR Questionnaire

Time Frame

month 3

Title

Change from baseline in patient and parents satisfaction measured by the ADHEAR Questionnaire

Time Frame

month 6

Title

Change from baseline in patient and parents satisfaction measured by the ADHEAR Questionnaire

Time Frame

month 12

Title

Number of subjects who discontinue study device utilization due to any AE or dissatisfaction

Time Frame

Year 1

Title

Average time of daily use of ADHEAR System

Description

Adherence reported by patient on a diary card.

Time Frame

week 3

Title

Incidence of device-emergent adverse event.

Description

Number of participants with device-related adverse events as assessed by CTCAE v4.0

Time Frame

Up to 1 year after start of study device utilization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Amélia Favoreel

Phone

0032 2 477 24 71

amelia.favoreel@huderf.be

First Name & Middle Initial & Last Name or Official Title & Degree

Jenne Keyen

Phone

0032 2 477 24 71

jenne.keyen@huderf.be

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anne-Laure Mansbach, MD PhD

Organizational Affiliation

Queen Fabiola Children's University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hôpital Universitaire Des Enfants Reine Fabiola

City

Brussel

ZIP/Postal Code

1020

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Amelia Favoreel

Phone

0032 2 477 24 71

amelia.favoreel@huderf.be

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31689608

Citation

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.

Results Reference

derived

Learn more about this trial

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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