At a glance
ClinicalIndex Comparison Record- ✓Age 18 years or older
- ✓Mixed hearing loss with bone conduction PTA4 of 30-55 dBHL in the ear to be implanted, OR single-sided sensorineural deafness with bone conduction PTA4 ≤30 dBHL in the best ear
- ✓For single-sided deafness, prior limited or no benefit from other sound processors tested on Baha Softband
- ✓Suitable for surgery with no previous implant on the side to be investigated
- ✕Scheduled for simultaneous bilateral implant surgery (unilateral use only)
- ✕Suitable implant position for BI300 Implant not found during surgery due to insufficient bone quality or thickness
- ✕Less than 3 mm soft tissue thickness at planned implant site
- ✕Prior radiation therapy on the same side of skull where device will be positioned
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluation of Audiological Outcomes and Subjective Benefits of Cochlear Baha® 5 SuperPower Sound Processor on the Baha® Attract™ System
In Brief
A clinical study evaluating Baha 5 SuperPower on Baha Attract System for Single Sided Sensorineural Deafness and Mixed Hearing Loss, Unilateral. Completed, enrolled 23 participants across 4 sites in 4 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
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.