Clinical Performance of a New Implant System for Bone Conduction Hearing
NCT ID: NCT03086135
Last Updated: 2021-10-14
Study Results
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View full resultsBasic Information
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COMPLETED
NA
51 participants
INTERVENTIONAL
2017-03-09
2019-06-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Bone-conduction hearing device
The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.
Osia System
An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.
Interventions
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Osia System
An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.
Eligibility Criteria
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Inclusion Criteria
* Subject with conductive or mixed hearing loss in the ear to be implanted. Bone conduction thresholds with pure tone average (PTA4; mean of 0.5, 1, 2 and 4 kHz) of 55 dB HL.
OR Subject with single-sided sensorineural deafness who is a candidate for Baha surgery. Air conduction thresholds with a pure tone average PTA4 of 20 dB HL (mean of 0.5, 1, 2 and 3 kHz) in the good ear OR subject who is indicated for an AC CROS but-for some reason-cannot or will not use an AC CROS (Air Conduction-Contralateral Routing of Signal).
* Signed informed consent
* Previous experience from amplified sound though a non-surgical solution. (For example but not limited to Hearing aid, CROS device, Bone conductional hearing device on headband/ softband)
Exclusion Criteria
* Condition that could jeopardise osseointegration and/or wound healing (e.g. osteoporosis, psoriasis, long-term systemic use of corticosteroids) or condition that may have an impact on the outcome of the investigation as judged by the investigator.
* Insufficient bone quality and quantity for implantation of a BI300 Implant.
* Subject that has received radiotherapy in the area of implantation, or is planned for such radiotherapy during the study period
* Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator
* Unable to follow investigational procedures, e.g. to complete quality of life scales.
* Participation in another clinical investigation with pharmaceutical and/or device.
18 Years
ALL
Yes
Sponsors
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Cochlear
INDUSTRY
Responsible Party
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Principal Investigators
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Emmanuel Mylanus, Prof.
Role: PRINCIPAL_INVESTIGATOR
Radboud Univerity Medical centre
Robert Briggs, Prof.
Role: PRINCIPAL_INVESTIGATOR
The Royal Victorian Eye and Ear Hospita
Susan Arndt, Prof.
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Freiburg
Piotr Skarżyński, Ass.Prof.
Role: PRINCIPAL_INVESTIGATOR
Center of Hearing and Speech
Henry Alexander Arts, Prof.
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan
Ann Arbor, Michigan, United States
The Royal Victorian Eye and Ear Hospital
East Melbourne, Victoria, Australia
University Medical Center Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Radboud University Medical Center
Nijmegen, , Netherlands
World Hearing Center Institute of Physiology and Pathology of Hearing
Kajetany, Nadarzyn, Poland
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CBAS5539
Identifier Type: -
Identifier Source: org_study_id