NCT03327194

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 31, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

January 31, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

February 15, 2018

Status Verified

February 1, 2018

Enrollment Period

1.8 years

First QC Date

October 25, 2017

Last Update Submit

February 14, 2018

Conditions

Conductive Hearing LossSingle Sided Deafness

Outcome Measures

Primary Outcomes (2)

  • Maximal decibels gain measured by Audiological basic tests

    Week 3

  • Maximal decibels gain measured by speech reception threshold in quiet

    Week 3

Secondary Outcomes (13)

  • 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

  • +8 more secondary outcomes

Study Arms (1)

ADHEAR Audio processor

EXPERIMENTAL
Device: ADHEAR Audio Processor

Interventions

ADHEAR Audio ProcessorDEVICE

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.

ADHEAR Audio processor

Eligibility Criteria

Age5 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Universitaire Des Enfants Reine Fabiola

Brussels, 1020, Belgium

RECRUITING

Related Publications (1)

  • 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.

    PMID: 31689608DERIVED

MeSH Terms

Conditions

Hearing Loss, Conductive

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Anne-Laure Mansbach, MD PhD

    Queen Fabiola Children's University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amélia Favoreel

CONTACT

0032 2 477 24 71amelia.favoreel@huderf.be

Jenne Keyen

CONTACT

0032 2 477 24 71jenne.keyen@huderf.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Monocentric prospective interventional single-subject design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2017

First Posted

October 31, 2017

Study Start

January 31, 2018

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

February 15, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)