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
Among 15 studies in Hearing Loss, Conductive by Cochlear — 1 open to participants now, 1 under way, none of them phase 3. Hearing Loss, Conductive · Cochlear.
Among the 15 studies in Hearing Loss, Conductive by Cochlear, this one is the 6th largest by enrollment, is one of 2 that started in 2017, is one of 15 with no phase, and was the 6th registered.
82 studies on the registry are indexed under Hearing Loss, Conductive; 15 are open to participants now.
Browse Hearing Loss, Conductive studies →1 of the 15 studies in Hearing Loss, Conductive by Cochlear is open now, in 1 country. Recruiting first, the newest first:
Cochlear · Sites in United Kingdom
Ages 18+
By country, each count listing its studies:
Of the 9 Hearing Loss, Conductive studies recruiting now, 5 set no upper age limit and 1 stops at 75 or younger; 3 take children under 18; 4 take healthy volunteers.
This study: 5 Years to 12 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
15 studies; the count open now beside each. This study's row is marked.
First in 2013; this study’s year is marked. 2 started in 2017.
This study's enrollment of 32 is close to the median of 30 across 59 interventional studies indexed under Hearing Loss, Conductive.
Median enrollment 29 across the 15 interventional studies. Of the 14 that completed or were terminated, 12 (86%) have results posted.
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Cochlear is the lead sponsor of 92 studies on the registry; 9 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 15 (88%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 15 studies in Hearing Loss, Conductive by Cochlear, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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
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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 |
|---|
Plan to share: No
Ran from Nov 2017 to primary completion in Nov 2018, 12 months.
Results were first posted in Apr 2019, 5 months after primary completion.
Of 37 interventional studies with no phase under Hearing Loss, Conductive, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 25. This study's 12 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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