Home Test of New Sound Processor

A Pivotal, Prospective, Single-centre, Randomized Test Order, Crossover, Open Label Study Comparing the Performance of a New Sound Processor With Unaided Hearing and Baha 5 in Adult Subjects With Conductive or Mixed Hearing Loss

The purpose of this clinical investigation is to test a new Sound Processor (SP) to compare hearing performance of the new Sound Processor with unaided hearing and Baha 5 SP in adult subjects and to investigate which device (new Sound Processor versus Baha 5) the subjects prefer.

Inclusion Criteria:

• Adult subject (18-<70 years of age)
• At least 12 months experience from using a Baha Connect system (percutaneous Baha)
• Subject with a conductive or mild to moderate mixed hearing loss. that would benefit from improved hearing from bone conduction device as judged by the research audiologist
• Willing and able to provide written informed consent

Exclusion Criteria:

• Signs of infection around the implant site
• Unable to follow investigational procedures
• Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator
• Investigator site personnel directly affiliated with this investigation and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
• Cochlear employees
• Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.