Evaluation of the Baha SoundArc in Pediatric Patients
1 other identifier
interventional
32
1 country
3
Brief Summary
The purpose of this study is to gather clinical performance data on the Baha SoundArc
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2017
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 2017
CompletedStudy Start
First participant enrolled
November 2, 2017
CompletedFirst Posted
Study publicly available on registry
November 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 2, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 2, 2018
CompletedResults Posted
Study results publicly available
April 11, 2019
CompletedApril 30, 2019
April 1, 2019
1 year
November 2, 2017
January 16, 2019
April 16, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
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
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
Study Arms (1)
Experimental SoundArc study group
EXPERIMENTALall subjects will receive the SoundArc intervention
Interventions
non-surgical attachment method for wearing a bone conduction hearing system
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cochlearlead
Study Sites (3)
Arizona Hearing and Balance
Chandler, Arizona, 85224, United States
Rady Children's Hospital
San Diego, California, 92123, United States
Cook Children's Hospital
Fort Worth, Texas, 76104, United States
Related Publications (1)
Moyer C, Purdy J, Carvalho D, Vaughan L, Shroyer L. Evaluation of the Baha SoundArc in children. Int J Pediatr Otorhinolaryngol. 2024 Apr;179:111925. doi: 10.1016/j.ijporl.2024.111925. Epub 2024 Mar 27.
PMID: 38552429DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- George Cire
- Organization
- Cochlear
Study Officials
- STUDY DIRECTOR
George Cire
Study Director
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 2017
First Posted
November 7, 2017
Study Start
November 2, 2017
Primary Completion
November 2, 2018
Study Completion
November 2, 2018
Last Updated
April 30, 2019
Results First Posted
April 11, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share