Evaluation of the Baha SoundArc in Pediatric Patients

Not Applicable

Completed

• Conditions: Hearing Loss, Unilateral; Hearing Loss, Conductive; Hearing Loss, Mixed
• Interventions: Device: SoundArc

• Registration Number: NCT03333577
• Lead Sponsor: Cochlear

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.

Study Timeline

• Study Start: 2017-11-02
• Study First Submitted: 2017-11-02
• Study First Submitted QC: 2017-11-03
• Study First Posted: 2017-11-07
• Primary Completion: 2018-11-02
• Study Completion: 2018-11-02
• Results First Submitted: 2019-01-16
• Results First Submitted QC: 2019-03-20
• Status Verified: 2019-04
• Results First Posted: 2019-04-11
• Last Update Submitted: 2019-04-16
• Last Update Posted: 2019-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental SoundArc study group	SoundArc	all subjects will receive the SoundArc intervention

Primary Outcome Measures

Name	Time	Method
Patient Satisfaction Survey	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	4 weeks post fitting	one list of monosyllabic words (PBK words) was assessed at 60dBA, with word scores recorded as a percent correct.

Trial Locations

Locations (3)

Arizona Hearing and Balance; 🇺🇸 Chandler, Arizona, United States

Rady Children's Hospital; 🇺🇸 San Diego, California, United States

Cook Children's Hospital; 🇺🇸 Fort Worth, Texas, United States