Home Test of New Sound Processor

Cochlear

Status: Completed

Conditions: Hearing Loss

Treatments: Device: New Sound Processor

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04559282

CBAS5779

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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16 participants in 2 patient groups

New SP followed by Baha 5 SP followed by single blinded SP

Experimental group

Description:

Aided hearing with new Sound Processor followed by aided hearing with the Baha 5 sound processor followed by unaided hearing followed by aided hearing with the new Sound Processor and Baha 5 in a laboratory environment (subject blinded for hearing testing).

Treatment:

Device: New Sound Processor

Baha 5 SP followed by the New SP followed by single blinded SP

Experimental group

Description:

Aided hearing with Baha 5 sound processor followed by aided hearing with the new Sound Processor followed by unaided hearing followed by aided hearing with the new Sound Processor and Baha 5 in a laboratory environment (subject blinded for hearing testing).

Treatment:

Device: New Sound Processor