Evaluation of the Baha SoundArc in Pediatric Patients

Cochlear

Status: Completed

Conditions: Hearing Loss, Conductive; Hearing Loss, Mixed; Hearing Loss, Unilateral

Treatments: Device: SoundArc

Study type: Interventional

Funder types: Industry

Identifiers

NCT03333577

CAM5714

Details and patient eligibility

About

The purpose of this study is to gather clinical performance data on the Baha SoundArc

Full description

Current Baha recipients that are using a Baha SoftBand will be recruited to be fitted with an alternative non-surgical option for using their Baha Sound Processor. The subjects will be tested with there existing Baha Sound Processor on the SoftBand and will then be fitted with the Baha SoundArc where they will perform a one month take home trial. At the end of this trial, the subject will return for testing and evaluation of their experience with this new fitting option.

Enrollment: 32 patients

Sex: All

Ages: 5 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:• Existing recipients using a Baha sound processor on a Softband for at least three months

• Subjects aged 5 through 12 years of age
• Subjects should be able to perform clinical testing adapted for age and developmental status, (Threshold sound field audiometry and basic monosyllabic word test, PBK)
• Willingness on behalf of the subject's parent or guardian to complete study questionnaire

Exclusion Criteria:• Subject's inability to perform requisite test measures as described in the study protocol

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Experimental SoundArc study group

Experimental group

Description:

all subjects will receive the SoundArc intervention

Treatment:

Device: SoundArc