Back to resultsEvaluation of the Baha SoundArc in Pediatric Patients
Primary Purpose
Hearing Loss, Conductive, Hearing Loss, Mixed, Hearing Loss, Unilateral
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SoundArc
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss, Conductive
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
-
Sites / Locations
- Arizona Hearing and Balance
- Rady Children's Hospital
- Cook Children's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental SoundArc study group
Arm Description
all subjects will receive the SoundArc intervention
Outcomes
Primary Outcome Measures
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)
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03333577
Brief Title
Evaluation of the Baha SoundArc in Pediatric Patients
Official Title
Evaluation of the Baha SoundArc in Pediatric Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
November 2, 2017 (Actual)
Primary Completion Date
November 2, 2018 (Actual)
Study Completion Date
November 2, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cochlear
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Conductive, Hearing Loss, Mixed, Hearing Loss, Unilateral
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental SoundArc study group
Arm Type
Experimental
Arm Description
all subjects will receive the SoundArc intervention
Intervention Type
Device
Intervention Name(s)
SoundArc
Intervention Description
non-surgical attachment method for wearing a bone conduction hearing system
Primary Outcome Measure Information:
Title
Patient Satisfaction Survey
Description
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)
Time Frame
one month post fitting
Title
Percentage Correct on Word Identification Task
Description
one list of monosyllabic words (PBK words) was assessed at 60dBA, with word scores recorded as a percent correct.
Time Frame
4 weeks post fitting
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Cire
Organizational Affiliation
Study Director
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Hearing and Balance
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Rady Children's Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Cook Children's Hospital
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of the Baha SoundArc in Pediatric Patients
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