Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
16 participants
INTERVENTIONAL
2020-09-23
2020-11-27
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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New SP followed by Baha 5 SP followed by single blinded SP
Aided hearing with new Sound Processor followed by aided hearing with the Baha 5 sound processor followed by unaided hearing followed by aided hearing with the new Sound Processor and Baha 5 in a laboratory environment (subject blinded for hearing testing).
New Sound Processor
The new Sound Processor is intended to be used as part of the Cochlear Baha System which uses bone conduction to transmit sounds to the cochlea. The New Sound Processor is indicated for patients with up to 55 dB sensorineural hearing loss.
Baha 5 SP followed by the New SP followed by single blinded SP
Aided hearing with Baha 5 sound processor followed by aided hearing with the new Sound Processor followed by unaided hearing followed by aided hearing with the new Sound Processor and Baha 5 in a laboratory environment (subject blinded for hearing testing).
New Sound Processor
The new Sound Processor is intended to be used as part of the Cochlear Baha System which uses bone conduction to transmit sounds to the cochlea. The New Sound Processor is indicated for patients with up to 55 dB sensorineural hearing loss.
Interventions
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New Sound Processor
The new Sound Processor is intended to be used as part of the Cochlear Baha System which uses bone conduction to transmit sounds to the cochlea. The New Sound Processor is indicated for patients with up to 55 dB sensorineural hearing loss.
Eligibility Criteria
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Inclusion Criteria
* At least 12 months experience from using a Baha Connect system (percutaneous Baha)
* Subject with a conductive or mild to moderate mixed hearing loss. that would benefit from improved hearing from bone conduction device as judged by the research audiologist
* Willing and able to provide written informed consent
Exclusion Criteria
* Unable to follow investigational procedures
* Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator
* Investigator site personnel directly affiliated with this investigation and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
* Cochlear employees
* Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.
18 Years
70 Years
ALL
No
Sponsors
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Statistiska Konsultgruppen
OTHER
Cochlear
INDUSTRY
Responsible Party
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Principal Investigators
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Karin Ganlöv, MD
Role: STUDY_DIRECTOR
Cochlear
Locations
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Cochlear Bone Anchored Solutions AB (CBAS)
Mölnlycke, , Sweden
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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CBAS5779
Identifier Type: -
Identifier Source: org_study_id