Hearing Loss, Conductive, Hearing Loss, Mixed, Hearing Loss, Unilateral
Conditions
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.
Interventions
DEVICESoundArc
non-surgical attachment method for wearing a bone conduction hearing system
Sponsors
Cochlear
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
No
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental SoundArc Study Group all subjects will receive the SoundArc intervention
SoundArc: non-surgical attachment method for wearing a bone conduction hearing system | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Experimental SoundArc Study Group | — |
|---|---|---|
| Age, Categorical <=18 years | 25 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 0 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 9 Participants | — |
| Sex: Female, Male Male | 16 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 1 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental SoundArc Study Group | Patient Satisfaction Survey | 65 percentage of satisfied subjects |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental SoundArc Study Group | Percentage Correct on Word Identification Task | 85.1 % corrrect words | Standard Deviation 13.6 |