Audiological Benefit With Non-implantable Bone Conduction Hearing Systems
NCT ID: NCT03129191
Last Updated: 2017-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
15 participants
INTERVENTIONAL
2017-07-01
2017-11-06
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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AB arm
Sequence:
1. Aided with non-invasive bone conduction hearing aid A
2. Aided with non-invasive bone conduction hearing aid B
Non-invasive bone conduction hearing aid A
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 B
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.
BA arm
Sequence:
1. Aided with non-invasive bone conduction hearing aid B
2. Aided with non-invasive bone conduction hearing aid A
Non-invasive bone conduction hearing aid A
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 B
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.
Interventions
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Non-invasive bone conduction hearing aid A
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 B
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Allergy against silicon (ear mold casting mass)
18 Years
ALL
Yes
Sponsors
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Insel Gruppe AG, University Hospital Bern
OTHER
Responsible Party
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Principal Investigators
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Martin Kompis, Prof
Role: PRINCIPAL_INVESTIGATOR
University Hospital Bern, Inselsptial
Locations
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Hearing Research Laboratory, University Hospital Bern
Bern, , Switzerland
Countries
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Other Identifiers
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HRL-NIBCH
Identifier Type: -
Identifier Source: org_study_id