Status:
COMPLETED
Evaluation of the Baha SoundArc in Pediatric Patients
Lead Sponsor:
Cochlear
Conditions:
Hearing Loss, Conductive
Hearing Loss, Mixed
Eligibility:
All Genders
5-12 years
Phase:
NA
Brief Summary
The purpose of this study is to gather clinical performance data on the Baha SoundArc
Detailed 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 the...
Eligibility Criteria
Inclusion
- • 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
- • Subject's inability to perform requisite test measures as described in the study protocol
- \-
Key Trial Info
Start Date :
November 2 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 2 2018
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT03333577
Start Date
November 2 2017
End Date
November 2 2018
Last Update
April 30 2019
Active Locations (3)
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1
Arizona Hearing and Balance
Chandler, Arizona, United States, 85224
2
Rady Children's Hospital
San Diego, California, United States, 92123
3
Cook Children's Hospital
Fort Worth, Texas, United States, 76104