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NCT03333577 Clinical Trial

Evaluation of the Baha SoundArc in Pediatric Patients

Hearing Loss, Conductive Clinical Trial

Official title:
Evaluation of the Baha SoundArc in Pediatric Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03333577
Other study ID # CAM5714
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2, 2017
Est. completion date November 2, 2018

Study information
Verified date April 2019
Source Cochlear
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 32
Est. completion date November 2, 2018
Est. primary completion date November 2, 2018
Accepts healthy volunteers No
Gender All
Age group 5 Years to 12 Years
Eligibility 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

-

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• SoundArc
non-surgical attachment method for wearing a bone conduction hearing system

Locations
Country Name City State
United States Arizona Hearing and Balance Chandler Arizona
United States Cook Children's Hospital Fort Worth Texas
United States Rady Children's Hospital San Diego California

Sponsors (1)
Lead Sponsor Collaborator
Cochlear

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Patient Satisfaction Survey 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) one month post fitting
Primary Percentage Correct on Word Identification Task one list of monosyllabic words (PBK words) was assessed at 60dBA, with word scores recorded as a percent correct. 4 weeks post fitting
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