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The primary objective of this study is to compare the SoundBiteâ„¢ Hearing System to surgically implanted BCD systems.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SoundBite | Other | SoundBite will be used for the first 30 days |
|
| Surgically Implanted BCD | Other | The subject's own surgically implanted bone conduction device will be used for the first 30 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SoundBite | Device | Non-surgical removable bone conduction device via the teeth. |
|
| Measure | Description | Time Frame |
|---|---|---|
| APHAB Questionnaire | Comparison of the SoundBiteâ„¢ System and surgically implanted bone conduction devices | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Single Sided Deafness Questionnaire | Comparison of the SoundBiteâ„¢ System and surgically implanted BCD systems. | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Linda Galow, M.S. | Contact | 1-650-581-5094 | linda@sonitusmedical.com |
| Name | Affiliation | Role |
|---|---|---|
| Charles Syms, MD | Ear Medical Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Ear Center | Phoenix | Arizona | 85004 | United States |
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| Label | URL |
|---|---|
| SoundBite Hearing System | View source |
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| Michigan Ear Institute | Novi | Michigan | 48374 | United States |
|
| Ear Medical Group | San Antonio | Texas | 78240 | United States |
|
| ID | Term |
|---|---|
| D046088 | Hearing Loss, Unilateral |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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