Conductive Hearing LossNCT03327194
Use of ADHEAR, a Non-Implantable Bone Conduction Hearing System, in Children With Single Sided Deafness and/or Conductive Hearing Loss
A study testing ADHEAR Audio Processor in people with Conductive Hearing Loss and Single Sided Deafness, run by Queen Fabiola Children's University Hospital at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Conductive Hearing Loss, Single Sided Deafness
- What is being tested?
- ADHEAR Audio Processor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- 31 Jan 2018to 1 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Hôpital Universitaire Des Enfants Reine Fabiola
Brussels, 1020
Amelia Favoreel, 0032 2 477 24 71, amelia.favoreel@huderf.be
About this study
Official title: 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.
Read more
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.
- Conditions
- Conductive Hearing Loss, Single Sided Deafness
- Being tested
- ADHEAR Audio Processor
- Medical subject headings
- Hearing Loss, Conductive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| ADHEAR Audio processor | Experimental | Not described Receives: Device: ADHEAR Audio Processor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal decibels gain measured by Audiological basic tests
Measured: Week 3
Maximal decibels gain measured by speech reception threshold in quiet
Measured: 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.
Measured: Day 0
Comparison of maximal decibels gain measured by speech reception threshold in quiet between ADHEAR Audio Processor and Cochlear bone anchored hearing aid
Measured: Day 0
Change from baseline in Quality of Life measured by the SSQ12 questionnaire
Measured: week 3
Change from baseline in Quality of Life measured by the SSQ12 questionnaire
Measured: month 3
Change from baseline in Quality of Life measured by the SSQ12 questionnaire
Measured: month 6
Change from baseline in Quality of Life measured by the SSQ12 questionnaire
Measured: month 12
Change from baseline in patient and parents satisfaction measured by the ADHEAR Questionnaire
Measured: week 3
Change from baseline in patient and parents satisfaction measured by the ADHEAR Questionnaire
Measured: month 3
Change from baseline in patient and parents satisfaction measured by the ADHEAR Questionnaire
Measured: month 6
Change from baseline in patient and parents satisfaction measured by the ADHEAR Questionnaire
Measured: month 12
Number of subjects who discontinue study device utilization due to any AE or dissatisfaction
Measured: Year 1
Average time of daily use of ADHEAR System
Adherence reported by patient on a diary card.
Measured: week 3
Incidence of device-emergent adverse event.
Number of participants with device-related adverse events as assessed by CTCAE v4.0
Measured: Up to 1 year after start of study device utilization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start31 Jan 2018
- Primary completion1 Dec 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Conductive Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Monocentric prospective interventional single-subject design
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Fabiola Children's University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- MED-EL Elektromedizinische Geräte GmbH
- Responsible party
- Sponsor
- Investigators
- Anne-Laure Mansbach, MD PhD, Principal investigator, Queen Fabiola Children's University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03327194
- Sponsor's protocol ID
- P2017/ORL/ADHEAR
- Status last verified
- Feb 2018
- First submitted
- 25 Oct 2017
- Last updated
- 15 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31689608
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subjective Satisfaction and Audiological Benefit With ADHEAR Audio Processor and ADHEAR Adhesive Adapter in Children
- ClinicalTrials.gov ID
- NCT03327194
- Acronym / sponsor ID
- P2017/ORL/ADHEAR
- Conditions
- Conductive Hearing Loss, Single Sided Deafness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Queen Fabiola Children's University HospitalUniversity, hospital or other
- Collaborators
- MED-EL Elektromedizinische Geräte GmbH
- Study start
- 31 Jan 2018 (actual)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 31 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Monocentric prospective interventional single-subject design
| Arm | Type | Receives |
|---|---|---|
| ADHEAR Audio processor | Experimental | Device: ADHEAR Audio Processor |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADHEAR Audio ProcessorADHEAR 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. | Device | ADHEAR Audio processor |
Primary outcome
Maximal decibels gain measured by Audiological basic tests
Time frame: Week 3
Maximal decibels gain measured by speech reception threshold in quiet
Time frame: Week 3
13 secondary outcomes
Comparison of maximal decibels gain measured by Audiological basic tests between ADHEAR Audio Processor and Cochlear bone anchored hearing aid.
Time frame: Day 0
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
Change from baseline in Quality of Life measured by the SSQ12 questionnaire
Time frame: week 3
Change from baseline in Quality of Life measured by the SSQ12 questionnaire
Time frame: month 3
Change from baseline in Quality of Life measured by the SSQ12 questionnaire
Time frame: month 6
Change from baseline in Quality of Life measured by the SSQ12 questionnaire
Time frame: month 12
Change from baseline in patient and parents satisfaction measured by the ADHEAR Questionnaire
Time frame: week 3
Change from baseline in patient and parents satisfaction measured by the ADHEAR Questionnaire
Time frame: month 3
Change from baseline in patient and parents satisfaction measured by the ADHEAR Questionnaire
Time frame: month 6
Change from baseline in patient and parents satisfaction measured by the ADHEAR Questionnaire
Time frame: month 12
Number of subjects who discontinue study device utilization due to any AE or dissatisfaction
Time frame: Year 1
Average time of daily use of ADHEAR System
Time frame: week 3
Incidence of device-emergent adverse event.
Time frame: Up to 1 year after start of study device utilization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2018.
- Derived from this study: PubMed 31689608Favoreel 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne-Laure Mansbach, MD PhD principal investigator
Queen Fabiola Children's University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADHEAR Audio Processor in people with Conductive Hearing Loss and Single Sided Deafness, run by Queen Fabiola Children's University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amélia Favoreel (0032 2 477 24 71, amelia.favoreel@huderf.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal decibels gain measured by Audiological basic tests (time frame: Week 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03327194, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2018.