Status:
COMPLETED
Clinical Performance of a Transcutaneous Bone Conduction Hearing Solution (Baha® Attract System)
Lead Sponsor:
Cochlear Bone Anchored Solutions
Conditions:
Deafness
Hearing Loss
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The rationale behind this clinical performance investigation is to collect data regarding the usability of the Baha Attract System in patients with hearing impairment that are candidates for Baha surg...
Eligibility Criteria
Inclusion
- Conductive hearing loss in the implanted ear. Bone conduction thresholds with a pure tone average of 500, 1000, 2000 and 3000 Hz \<30 decibel (dB) hearing level (HL)
- Single-sided Sensorineural Deafness (SSD). Bone conduction thresholds with a pure tone average of 500, 1000, 2000 and 3000 Hz \<30 dB hearing level (HL) in the best ear
- Signed informed consent
Exclusion
- Uncontrolled diabetes as judged by the investigator
- Condition that could jeopardize osseointegration and/or wound healing, e.g. osteoporosis, psoriasis and use of corticosteroids
- Unable to follow investigational procedures, e.g. to complete quality of life scales
- Less than 4mm of soft tissue pre-operatively
- Participation in another investigation with pharmaceuticals and/or device
- Condition that may have an impact on the outcome of the investigation as judged by the investigator
- Subjects that have received radiation therapy at the same side of the skull where the Baha Attract will be positioned
- Suitable implant position for the Baha BI300 implant system (4 mm and 3 mm) not found during surgery due to insufficient bone quality and/or bone thickness
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01822119
Start Date
March 1 2013
End Date
February 1 2014
Last Update
February 6 2017
Active Locations (4)
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1
The HEARing CRC & HearWorks, University of Melbourne
Melbourne, Victoria, Australia, 3010
2
Clinica Las Condes
Santiago, Chile
3
The Chinese University of Hong Kong
Hong Kong, Hong Kong
4
Bnai Zion MedicalCenter
Haifa, Israel, 31048