Conductive Hearing LossNCT03864731
Quality of Life With Bone Conduction Hearing Device
A study testing Bone conduction device (ADHEAR) in people with Conductive Hearing Loss, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The aim of this study is to compare the audiological and quality of life performance patients have with an ADHEAR (adhesive bone conduction device) compared to no hearing device. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Conductive Hearing Loss
- What is being tested?
- Bone conduction device (ADHEAR)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteAustria
- Study dates
- 25 Feb 2019to 31 Oct 2024
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Unilateral and/or bilateral conductive hearing loss (CHL)
- Conductive hearing loss >10 decibel on average
- Subjective benefit from the device
- Subjects aged 13 years or older
- Capable of the German language
- Willingness and ability to perform all tests required for the study
- Signed, and dated informed consent before the start of any study specific procedure
Who cannot join
- Pregnancy or breastfeeding
- Patient uses a hearing aid or plans to acquire a hearing aid
- Patient is intolerant of the materials as described by Manufacturer
- Patient presents with a skin or scalp condition that may preclude the attachment of the adhesive adapter.
- Patient cannot perform the audiological tests or is unable to fill out the questionnaires.
- Patient presents with retrocochlear, or central auditory disorder.
- 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.
About this study
Official title: Audiological Benefit and Improved Quality of Life in Patients With a Bone Conduction Device - a Randomized Controlled Trial
The aim of this study is to compare the audiological and quality of life performance patients have with an ADHEAR (adhesive bone conduction device) compared to no hearing device.
Read the detailed description
Patients will be recruited at the outpatient's department of the Medical University of Vienna - Otorhinolaryngology department. Patient will be asked to participate in the study when inclusion and exclusion criteria are met. Mostly patients scheduled for a surgery improving conductive hearing loss or scheduled for implantation of an implantable bone conduction hearing aid will be included in the study.
Patients who do not use a hearing aid and who are not planning on using a hearing aid meeting the inclusion and exclusion criteria will also be asked to participate in the study. After inclusion in the study patients will be asked to fill out two questionnaires (quality of life and hearing specific questionnaire). They will then be fitted with an ADHEAR device and undergo unaided and aided soundfield audiometry. Randomization will be carried out (Randomization ratio 1.4:1) and patients in the intervention group will keep the device for the following 4 months with one visit after the first probation time of one month. At the one month mark patients in the control group will be asked to fill out the two questionnaires. Patients in the control group will be asked to return to the department and fill out the three questionnaires (SSQ-12 (Speech Spatial and Hearing Questionnaire), AQoL(Assessment of Quality of Life) and In-house questionnaire). Further audiologic assessment will be carried out. At this appointment patients will be able to talk about their experiences in the probation period und easily terminate the study in case of insufficient improvement, pain, skin irritations or other issues. At the four month mark patients in both groups will be asked to return for audiologic assessment and for filling out the questionnaires.
- Conditions
- Conductive Hearing Loss
- Being tested
- Bone conduction device (ADHEAR)
- 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.
Bone conduction device (ADHEAR)Device
adhesive bone conduction device
| Study group | Role | What they receive |
|---|---|---|
| Bone conduction device - ADHEAR | Other | Patients will receive a hearing aid (ADHEAR). Hearing assessment will be carried out. Quality of life measurement will be carried out. Receives: Device: Bone conduction device (ADHEAR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
AQoL (Assessment of Quality of Life) Results
The primary objective of this study is to evaluate, whether patients using ADHEAR have a significantly improved quality of life compared to patients not fitted with a device with the AQoL (Assessment of Quality of Life) questionnaire. It comprises 35 questions covering a multitude of quality of life aspects. Weighted utilities are generated using the algorithms provided on the AQoL website. Weighted utilities give a number between 0 and 1 as answer for every question. These sub scores are then presented.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start25 Feb 2019
- Primary completion31 Jul 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conductive Hearing LossStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valerie Dahm, Medical University of Vienna
- Investigators
- Valerie Dahm, MD, Principal investigator, MUW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03864731
- Sponsor's protocol ID
- 2087/2018
- Status last verified
- May 2025
- First submitted
- 24 Feb 2019
- Last updated
- 13 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Audiological Benefit and Improved Quality of Life in Patients With a Bone Conduction Device - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03864731
- Acronym / sponsor ID
- 2087/2018
- Conditions
- Conductive Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 6 Mar 2019 (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.
The aim of this study is to compare the audiological and quality of life performance patients have with an ADHEAR (adhesive bone conduction device) compared to no hearing device.
Detailed description
Patients will be recruited at the outpatient's department of the Medical University of Vienna - Otorhinolaryngology department. Patient will be asked to participate in the study when inclusion and exclusion criteria are met. Mostly patients scheduled for a surgery improving conductive hearing loss or scheduled for implantation of an implantable bone conduction hearing aid will be included in the study.
Patients who do not use a hearing aid and who are not planning on using a hearing aid meeting the inclusion and exclusion criteria will also be asked to participate in the study. After inclusion in the study patients will be asked to fill out two questionnaires (quality of life and hearing specific questionnaire). They will then be fitted with an ADHEAR device and undergo unaided and aided soundfield audiometry. Randomization will be carried out (Randomization ratio 1.4:1) and patients in the intervention group will keep the device for the following 4 months with one visit after the first probation time of one month. At the one month mark patients in the control group will be asked to fill out the two questionnaires. Patients in the control group will be asked to return to the department and fill out the three questionnaires (SSQ-12 (Speech Spatial and Hearing Questionnaire), AQoL(Assessment of Quality of Life) and In-house questionnaire). Further audiologic assessment will be carried out. At this appointment patients will be able to talk about their experiences in the probation period und easily terminate the study in case of insufficient improvement, pain, skin irritations or other issues. At the four month mark patients in both groups will be asked to return for audiologic assessment and for filling out the questionnaires.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bone conduction device - ADHEAR | Other | Device: Bone conduction device (ADHEAR)Patients will receive a hearing aid (ADHEAR). Hearing assessment will be carried out. Quality of life measurement will be carried out. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Unilateral and/or bilateral conductive hearing loss (CHL)
- Conductive hearing loss >10 decibel on average
- Subjective benefit from the device
- Subjects aged 13 years or older
- Capable of the German language
Key exclusion criteria (7 listed)
- Pregnancy or breastfeeding
- Patient uses a hearing aid or plans to acquire a hearing aid
- Patient is intolerant of the materials as described by Manufacturer
- Patient presents with a skin or scalp condition that may preclude the attachment of the adhesive adapter.
- Patient cannot perform the audiological tests or is unable to fill out the questionnaires.
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 |
|---|---|---|
| Bone conduction device (ADHEAR)adhesive bone conduction device | Device | Bone conduction device - ADHEAR |
Primary outcome
AQoL (Assessment of Quality of Life) Results
Time frame: 4 months
The primary objective of this study is to evaluate, whether patients using ADHEAR have a significantly improved quality of life compared to patients not fitted with a device with the AQoL (Assessment of Quality of Life) questionnaire. It comprises 35 questions covering a multitude of quality of life aspects. Weighted utilities are generated using the algorithms provided on the AQoL website. Weighted utilities give a number between 0 and 1 as answer for every question. These sub scores are then presented.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- 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.
Valerie Dahm, MD principal investigator
MUW
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone conduction device (ADHEAR) in people with Conductive Hearing Loss, run by Medical University of Vienna at 1 site in Austria.
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 7 inclusion and 7 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: finished, as of the sponsor's last update on 13 May 2025. 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 Austria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AQoL (Assessment of Quality of Life) Results (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2025.