Evaluation of the Baha SoundArc in Pediatric Patients
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Hearing Loss, Conductive
- Sponsor
- Cochlear
- Enrollment
- 32
- Locations
- 3
- Primary Endpoint
- Patient Satisfaction Survey
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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 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.
Investigators
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
Outcomes
Primary Outcomes
Patient Satisfaction Survey
Time Frame: one month post fitting
To evaluate patient experience when using the Baha SoundArc after a one month take-home trial, compared to the existing Baha Softband on the Participant Take Home questionnaire (strongly agree, Agree, Neutral, disagree, strongly disagree)
Percentage Correct on Word Identification Task
Time Frame: 4 weeks post fitting
one list of monosyllabic words (PBK words) was assessed at 60dBA, with word scores recorded as a percent correct.