Evaluation of Cochlear Baha 5 SuperPower Sound Processor on the Baha Attract System
NCT ID: NCT02722330
Last Updated: 2019-06-03
Study Results
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View full resultsBasic Information
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COMPLETED
NA
23 participants
INTERVENTIONAL
2016-04-30
2016-12-31
Brief Summary
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Detailed Description
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The Cochlear Baha 5 SuperPower Sound Processor is the first head-worn sound processor within the Super Power segment and has a fitting range of 65 dBHL. It is CE marked and is intended for subjects with mixed hearing loss or single-sided sensorineural deafness (SSD). It can be used with the Baha Connect and Baha Attract Systems and with a Baha Softband. When used in combination with the Baha Attract System, it will be able to compensate for a larger sensorineural component than the current Premium and Power sound processors and, hence, will allow more subjects to benefit from the Baha Attract System. The combination Baha Attract System with Baha 5 SuperPower Sound Processor is the most powerful non-skin penetrating bone conduction hearing implant solution available today.
The Baha 5 SuperPower Sound Processor includes discreet design, advanced signal processing and improved connectivity to external sound sources. The new sound processor supports Cochlear's 2.4 GHz wireless protocol and is programmable with a new version of the Baha 5 Fitting Software.
The aim of this clinical investigation is to evaluate objective and subjective hearing performance with the Cochlear Baha 5 SuperPower Sound Processor on the Baha Attract System, compared to the unaided hearing performance. Comparison of audiological test results with the same sound processor on a Baha Softband will also be performed. Short term safety parameters will be collected.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Baha 5 SuperPower on Baha Attract System
The device involves the following parts:
The sound processor unit, an actuator unit and a cable, the Sound Processor Magnet (SP Magnet) of the Baha Attract System, the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant, a snap coupling.
Baha 5 SuperPower on Baha Attract System
The Investigational device involves the following parts: the sound processor unit, an actuator unit and a cable that connects the sound processor and actuator units. The actuator unit is attached to the Sound Processor Magnet (SP Magnet) of the Baha Attract System which is pulled towards the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant. The actuator unit can also be connected to the Baha Softband via a snap coupling.
Interventions
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Baha 5 SuperPower on Baha Attract System
The Investigational device involves the following parts: the sound processor unit, an actuator unit and a cable that connects the sound processor and actuator units. The actuator unit is attached to the Sound Processor Magnet (SP Magnet) of the Baha Attract System which is pulled towards the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant. The actuator unit can also be connected to the Baha Softband via a snap coupling.
Eligibility Criteria
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Inclusion Criteria
* Mixed hearing loss in the ear to be implanted. Bone conduction thresholds with pure tone average (PTA4, Mean of 0.5, 1, 2 and 4kHz) of 30-55 dBHL or
* Single-sided sensorineural deafness: Bone conduction thresholds with a pure tone average \[PTA4, Mean of 0.5, 1, 2 and 4 kHz\] of lower or 30 dBHL in the best ear. Subjects who have, for some reason, experienced no or limited benefit from other sound processors when tested on a Baha Softband.
* Subjects suitable for surgery according to the recommended surgical procedure for Cochlear Baha 5 SuperPower with no previous implant on the side to be investigated.
* Signed inform consent.
Exclusion Criteria
* Suitable implant position for the BI300 Implant (4 mm or 3 mm) not found during surgery due to insufficient bone quality and/or bone thickness
* Subjects that have received radiation therapy at the same side of the skull where the Investigational device will be positioned.
* Uncontrolled diabetes as judged by the investigator.
* Condition that could jeopardise osseointegration and/or wound healing (e.g. osteoporosis, psoriasis and long-term systemic use of corticosteroids) or condition that may have an impact on the outcome of the investigation 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
No
Sponsors
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Cochlear Bone Anchored Solutions
INDUSTRY
Responsible Party
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Principal Investigators
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Jaydip Ray, Professor
Role: PRINCIPAL_INVESTIGATOR
Royal Hallamshire Hospital
César Orús, Dr
Role: PRINCIPAL_INVESTIGATOR
Hospital de Sant Pau
Paul Van de Heyning, Professor
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Antwerp
Jesper Schmidt, Dr
Role: PRINCIPAL_INVESTIGATOR
Odense University Hospital
Locations
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Antwerp University Hospital
Antwerp, , Belgium
Odense University Hospital
Odense, , Denmark
Hospital de Sant Pau
Barcelona, , Spain
Royal Hallamshire Hospital
Sheffield, , United Kingdom
Countries
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Other Identifiers
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CBAS5619
Identifier Type: -
Identifier Source: org_study_id
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