Evaluation of the Baha SoundArc in Pediatric Patients



Status:Recruiting
Conditions:Other Indications, Other Indications
Therapuetic Areas:Other
Healthy:No
Age Range:5 - 12
Updated:11/9/2017
Start Date:November 2, 2017
End Date:November 2, 2018
Contact:George Cire, Au.D
Email:gcire@cochlear.com
Phone:303 264 2405

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

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.

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
We found this trial at
3
sites
Fort Worth, Texas 76104
Phone: 682-885-4063
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Chandler, Arizona 85224
Phone: 480-558-5306
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San Diego, California 92123
Phone: 858-966-5838
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San Diego, CA
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