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 |
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.
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
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3
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