An interventional study of SoundArc in Hearing Loss, Conductive, Hearing Loss, Mixed and Hearing Loss, Unilateral, sponsored by Cochlear. Completed at 3 sites in United States. Open to participants aged 5 Years to 12 Years. Per ClinicalTrials.gov, last updated 2019-04-30.
Sponsored by Cochlear · Not applicable, Interventional, and Treatment
The purpose of this study is to gather clinical performance data on the Baha SoundArc
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.
Inclusion Criteria:• Existing recipients using a Baha sound processor on a Softband for at least three months
Exclusion Criteria:• Subject's inability to perform requisite test measures as described in the study protocol
-
all subjects will receive the SoundArc intervention
Device: SoundArc
non-surgical attachment method for wearing a bone conduction hearing system
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)
Time frame: 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.
Time frame: 4 weeks post fitting
| Milestone | Experimental SoundArc Study Group |
|---|---|
| Started | 32 |
| Completed | 25 |
| Not completed | 7 |
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 of satisfied subjects | Experimental SoundArc Study Group |
|---|---|
| Patient Satisfaction Survey | 65 |
one list of monosyllabic words (PBK words) was assessed at 60dBA, with word scores recorded as a percent correct.
| % corrrect words | Experimental SoundArc Study Group |
|---|---|
| Percentage Correct on Word Identification Task | 85.1 ± 13.6 |
Collected over Study duration use one month interval. Adverse events were recorded from time of consent/enrollment until completion of study. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental SoundArc Study Group | 0/25 (0%) | 0/25 (0%) | 1/25 (4%) |
| Event | Experimental SoundArc Study Group |
|---|---|
| irritation from use of DeviceMusculoskeletal and connective tissue disorders | 1/25 |
| Age, Categorical(Participants) | Experimental SoundArc Study Group |
|---|---|
| <=18 years | 25 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Experimental SoundArc Study Group |
|---|---|
| Female | 9 |
| Male | 16 |
| Race and Ethnicity Not Collected(Participants) | Experimental SoundArc Study Group |
|---|
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