Clinical Performance of a Transcutaneous Bone Conduction Hearing Solution (Baha® Attract System)
NCT01822119 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27
Last updated 2017-02-06
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 surgery:
* To describe the expected hearing performance with the Baha Attract in comparison to unaided hearing thresholds or a pre-test situation using a sound processor together with a softband
* Which sound processor to select, i.e. BP100 vs BP110
* Improve the fitting process for the sound processor
* Selection of sound processor magnet at time of fitting and over time
Conditions
- Deafness
- Hearing Loss
- Hearing Loss, Conductive
Interventions
- DEVICE
-
Baha Attract System
Sponsors & Collaborators
-
Cochlear Bone Anchored Solutions
lead INDUSTRY
Principal Investigators
-
Robert Cowan, A/Professor · The HEARing CRC & HearWorks, University of Melbourne
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-03-31
- Primary Completion
- 2014-02-28
- Completion
- 2014-02-28
Countries
- Australia
- Chile
- Hong Kong
- Israel
Study Locations
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