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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental SoundArc study group | Experimental | all subjects will receive the SoundArc intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SoundArc | Device | non-surgical attachment method for wearing a bone conduction hearing system |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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. | 4 weeks post fitting |
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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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| Name | Affiliation | Role |
|---|---|---|
| George Cire | Study Director | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Hearing and Balance | Chandler | Arizona | 85224 | United States | ||
| Rady Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38552429 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental SoundArc Study Group | all subjects will receive the SoundArc intervention SoundArc: non-surgical attachment method for wearing a bone conduction hearing system |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental SoundArc Study Group | all subjects will receive the SoundArc intervention SoundArc: non-surgical attachment method for wearing a bone conduction hearing system |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 25 subjects completed visit 1 and 2 and were analyzed |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Number | percentage of satisfied subjects | one month post fitting |
|
|
Study duration use one month interval. Adverse events were recorded from time of consent/enrollment until completion of study
Adverse events were recorded from time of consent/enrollment until completion of study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental SoundArc Study Group | all subjects will receive the SoundArc intervention SoundArc: non-surgical attachment method for wearing a bone conduction hearing system |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| irritation from use of Device | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| George Cire | Cochlear | 303 885 5440 | gcire@msn.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 18, 2017 | Jan 16, 2019 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D006314 | Hearing Loss, Conductive |
| D046089 | Hearing Loss, Mixed Conductive-Sensorineural |
| D046088 | Hearing Loss, Unilateral |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| San Diego |
| California |
| 92123 |
| United States |
| Cook Children's Hospital | Fort Worth | Texas | 76104 | United States |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | 25 subjects completed visit 1 and 2 and were analyzed | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| 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. | Posted | Mean | Standard Deviation | % corrrect words | 4 weeks post fitting |
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| 0 |
| 25 |
| 0 |
| 25 |
| 1 |
| 25 |
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| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |