Hearing Loss, ConductiveNCT03129191
Audiological Benefit With Non-implantable Bone Conduction Hearing Systems
A study testing Non-invasive bone conduction hearing aid A and Non-invasive bone conduction hearing aid B in people with Hearing Loss, Conductive, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Recently, a new non-invasive bone conduction hearing aid was introduced. The system is connected directly to the skin with an adhesive adapter to transmit the sound to the inner ear through bone vibrations. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Conductive
- What is being tested?
- Non-invasive bone conduction hearing aid A and Non-invasive bone conduction hearing aid B
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2017to 6 Nov 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written informed consent
- Adults (age ≥ 18 years on the test date)
- Normal hearing thresholds (AC/BC-thresholds ≤ 20 dB HL, 0.25 to 8 kHz)
- German native speakers
- Willingness and ability to perform all tests required for the study
Who cannot join
- Lack of compliance with any inclusion criteria
- Allergy against silicon (ear mold casting mass)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Hearing Research Laboratory, University Hospital Bern
Bern, 3008
About this study
Recently, a new non-invasive bone conduction hearing aid was introduced. The system is connected directly to the skin with an adhesive adapter to transmit the sound to the inner ear through bone vibrations. The objective of this study is to evaluate and compare the audiological benefit of the new bone conduction hearing aid and compare it to an existing bone conduction hearing aid in normal hearing adults with bilateral simulated conductive hearing loss.
An evaluation of the improvement on speech understanding in noise and sound localization allows to estimate the system performance and enables to derive recommendations for clinical usage of the novel hearing system. It is hypothesized that in the bilateral condition similar speech understanding in noise and sound localization performance can be achieved with the new system compared to existing bone conduction hearing aids that are pressed against the skull using a soft band.
- Conditions
- Hearing Loss, Conductive
- Being tested
- Non-invasive bone conduction hearing aid A, Non-invasive bone conduction hearing aid B
- 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.
Non-invasive bone conduction hearing aid ADevice
The intervention is a non-invasive bone conduction hearing device which is retained on the patient's head with an elastic headband.
Non-invasive bone conduction hearing aid BDevice
The intervention is 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.
| Study group | Role | What they receive |
|---|---|---|
| AB arm | Active comparator | Sequence:
1. Aided with non-invasive bone conduction hearing aid A
2. Aided with non-invasive bone conduction hearing aid B Receives: Device: Non-invasive bone conduction hearing aid A; Device: Non-invasive bone conduction hearing aid B |
| BA arm | Active comparator | Sequence:
1. Aided with non-invasive bone conduction hearing aid B
2. Aided with non-invasive bone conduction hearing aid A Receives: Device: Non-invasive bone conduction hearing aid A; Device: Non-invasive bone conduction hearing aid B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech reception threshold in noise (S0NDIFF)
Speech reception threshold in noise (in dB SNR) measured with speech presented from the front (0° azimuth) and approximated diffuse noise presented from 4 speakers.
Measured: Day 1
Secondary outcomes (4)
Speech reception threshold in noise (S90NDIFF)
Speech reception threshold in noise (in dB SNR) measured with speech presented from the right side (90° azimuth) and approximated diffuse noise presented from 4 speakers.
Measured: Day 1
Speech reception threshold in noise (S270NDIFF)
Speech reception threshold in noise (in dB SNR) measured with speech presented from the left side (270° azimuth) and approximated diffuse noise presented from 4 speakers.
Measured: Day 1
Sound localization
Mean absolute localization error (in degrees)
Measured: Day 1
Subjective evaluation of the sound quality
Assessment of the sound quality with questionnaire by Gabrielsson et al.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start1 Jul 2017
- Primary completion6 Nov 2017
- Study completion6 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, ConductiveStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Kompis, Prof, Principal investigator, University Hospital Bern, Inselsptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03129191
- Sponsor's protocol ID
- HRL-NIBCH
- Status last verified
- Nov 2017
- First submitted
- 19 Apr 2017
- Last updated
- 8 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Audiological Benefit With Non-implantable Bone Conduction Hearing Systems
- ClinicalTrials.gov ID
- NCT03129191
- Acronym / sponsor ID
- HRL-NIBCH
- Conditions
- Hearing Loss, Conductive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 6 Nov 2017 (actual)
- Study completion
- 6 Nov 2017 (actual)
- First posted
- 26 Apr 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.
Recently, a new non-invasive bone conduction hearing aid was introduced. The system is connected directly to the skin with an adhesive adapter to transmit the sound to the inner ear through bone vibrations. The objective of this study is to evaluate and compare the audiological benefit of the new bone conduction hearing aid and compare it to an existing bone conduction hearing aid in normal hearing adults with bilateral simulated conductive hearing loss.
An evaluation of the improvement on speech understanding in noise and sound localization allows to estimate the system performance and enables to derive recommendations for clinical usage of the novel hearing system. It is hypothesized that in the bilateral condition similar speech understanding in noise and sound localization performance can be achieved with the new system compared to existing bone conduction hearing aids that are pressed against the skull using a soft band.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AB arm | Active comparator | Device: Non-invasive bone conduction hearing aid A, Device: Non-invasive bone conduction hearing aid BSequence: 1. Aided with non-invasive bone conduction hearing aid A 2. Aided with non-invasive bone conduction hearing aid B |
| BA arm | Active comparator | Device: Non-invasive bone conduction hearing aid A, Device: Non-invasive bone conduction hearing aid BSequence: 1. Aided with non-invasive bone conduction hearing aid B 2. Aided with non-invasive bone conduction hearing aid A |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written informed consent
- Adults (age ≥ 18 years on the test date)
- Normal hearing thresholds (AC/BC-thresholds ≤ 20 dB HL, 0.25 to 8 kHz)
- German native speakers
- Willingness and ability to perform all tests required for the study
Key exclusion criteria (2 listed)
- Lack of compliance with any inclusion criteria
- Allergy against silicon (ear mold casting mass)
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 |
|---|---|---|
| Non-invasive bone conduction hearing aid AThe intervention is a non-invasive bone conduction hearing device which is retained on the patient's head with an elastic headband. | Device | AB arm, BA arm |
| Non-invasive bone conduction hearing aid BThe intervention is 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. | Device | AB arm, BA arm |
Primary outcome
Speech reception threshold in noise (S0NDIFF)
Time frame: Day 1
Speech reception threshold in noise (in dB SNR) measured with speech presented from the front (0° azimuth) and approximated diffuse noise presented from 4 speakers.
4 secondary outcomes
Speech reception threshold in noise (S90NDIFF)
Time frame: Day 1
Speech reception threshold in noise (S270NDIFF)
Time frame: Day 1
Sound localization
Time frame: Day 1
Subjective evaluation of the sound quality
Time frame: Day 1
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 8 Nov 2017.
- Individual participant dataSharing planned: Undecided
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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.
Martin Kompis, Prof principal investigator
University Hospital Bern, Inselsptial
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive bone conduction hearing aid A and Non-invasive bone conduction hearing aid B in people with Hearing Loss, Conductive, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 5 inclusion and 2 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 8 Nov 2017. 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 Switzerland. 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?
Speech reception threshold in noise (S0NDIFF) (time frame: Day 1). 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 8 Nov 2017.