| Registry | NCT03333577 |
|---|
| Status | Completed |
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| Phase | Not applicable |
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| Study type | Interventional; na, single group, masking: none, treatment |
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| Enrollment | 32 (Actual) |
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| Sponsor | Cochlear (Industry) |
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| Conditions | Hearing Loss, Conductive, Hearing Loss, Mixed, Hearing Loss, Unilateral |
|---|
| Interventions | SoundArc (Device) |
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| Dates | start 2017-11-02, primary completion 2018-11-02, completion 2018-11-02, first posted 2017-11-07, last updated 2019-04-30 |
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| Locations | 3 sites in United States |
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-Summary
The purpose of this study is to gather clinical performance data on the Baha SoundArc
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+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.
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Experimental SoundArc study group | Experimental | Device: SoundArc | all subjects will receive the SoundArc intervention |
- SoundArc (Device): non-surgical attachment method for wearing a bone conduction hearing system
+Outcome measures
Primary outcomes
- 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.
+Eligibility
Sex: All, ages: 5 Years to 12 Years
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
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+Posted results
Participant flow
| Milestone | Experimental SoundArc Study Group |
|---|
| Started | 32 |
| Completed | 25 |
| Not completed | 7 |
Outcome results
- Patient Satisfaction Survey (Primary), Number, percentage of satisfied subjects: Experimental SoundArc Study Group 65
- Percentage Correct on Word Identification Task (Primary), Mean, % corrrect words: Experimental SoundArc Study Group 85.1 +/- 13.6
Adverse events
Time frame: Study duration use one month interval. Adverse events were recorded from time of consent/enrollment until completion of study
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|
| Experimental SoundArc Study Group | 0/25 (0.0%) | 0/25 (0.0%) | 1/25 (4.0%) |
Other adverse events by term
| Term | Organ system | Experimental SoundArc Study Group |
|---|
| irritation from use of Device | Musculoskeletal and connective tissue disorders | 1/25 |
+Locations (3)
| Facility | City | Country | Status |
|---|
| 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 | |
+Publications
- Results publication: 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 38552429
+Study documents
+Investigators