NCT01822119

Clinical Performance of a Transcutaneous Bone Conduction Hearing Solution (Baha® Attract System)

Clinical Performance of a Transcutaneous Bone Conduction Hearing Solution (Baha® Attract System). A Multicentre, Open, Prospective Clinical Investigation. 3 Months Investigation With a 6 Months Follow-up

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Cochlear Bone Anchored Solutions · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DEVICE	Baha Attract System

Timeline

• Start date: 2013-03-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2013-04-02
• Last updated: 2017-02-06
• Results posted: 2017-02-06

Locations

4 sites across 4 countries: Australia, Chile, Hong Kong, Israel