Mixed Hearing Loss, Unilateral Clinical Trial
Official title:
Evaluation of Audiological Outcomes and Subjective Benefits of Cochlear Baha® 5 SuperPower Sound Processor on the Baha® Attract™ System
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.
The Cochlear Baha bone conduction hearing implant offers two alternative ways to transmit
vibrations from the external sound processor to the osseointegrated implant: The Baha Connect
System uses a skin-penetrating abutment and allows direct bone conduction. The Baha Attract
System uses a magnetic connection through intact skin. Magnetic bone conduction hearing
implants have the advantage over skin-penetrating systems of eliminating the daily cleaning
of the site and are perceived as a more cosmetically appealing by some subjects. With modern
sound processor technology, it is possible to obtain good sound transmission despite the soft
tissue attenuation that is inherent to magnetic bone conduction hearing implants. Clinical
investigations have shown that the Baha Attract System, when used in combination with
existing head-worn sound processors within the Premium (e.g. BP100, Baha 4 Sound Processors)
and Power (BP110 Sound processor) segments, provides good hearing outcomes in subjects with
conductive and mild mixed hearing loss.
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.
;