N/A
Completed N=32
Evaluation of the Baha SoundArc in Pediatric Patients
Hearing Loss, Conductive · Hearing Loss, Mixed · Hearing Loss, Unilateral
Source: ClinicalTrials.gov NCT03333577 ↗
Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcomePrimary: Patient Satisfaction Survey — 65 percentage of satisfied subjects
Summary
The purpose of this study is to gather clinical performance data on the Baha SoundArc
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Satisfaction Survey |
65 | — |
| PRIMARY Percentage Correct on Word Identification Task |
85.1 | — |
Eligibility 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
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Data sourced from ClinicalTrials.gov (NCT03333577). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.