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This study is designed to collect data about the SoundBiteâ„¢ Hearing System to answer specific questions. The hearing system has been cleared for commercial distribution by the Food and Drug Administration (FDA). Sonitus hopes to learn from a larger group of users what features and settings of this device provide the best hearing ability for people diagnosed with Single Sided Deafness (SSD) or Conductive Hearing Loss (CHL).
The Sonitus SoundBite Hearing System prosthetic device is a bone conduction device that has been FDA cleared for treatment of single-sided deafness (SSD) and conductive hearing loss (CHL). The Sonitus SoundBite Hearing System consists of an In the Mouth (ITM) component an external microphone component, worn behind the ear (BTE), a calibration interface cable and PC-controlled calibration software for subject calibration. A charger is also provided to charge the ITM and the BTE. The objective of this multi-sites observational study is to assess the long-term patient use of the Sonitus SoundBite Hearing System.
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| Measure | Description | Time Frame |
|---|---|---|
| Aided Threshold Testing | Aided threshold testing of the impaired ear at 12 months as compared with baseline using the SoundBite Hearing System | 12 months |
| Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire | Change in Abbreviated Profile of Hearing Aid Benefit (APHAB, Form A - New Format, Hearing Aid Research Lab, University of Memphis, 1994) score at 12 months compared to baseline | 12 months |
| Single Sided Deafness Questionnaire | This questionnaire assesses qualitative outcomes. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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All trial subjects are individuals that have decided to purchase SoundBite Hearing System for treatment of their Single Sided Deafness or Conductive Hearing Loss and are willing to participate in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Gerald Popelka, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Ear Center | Phoenix | Arizona | 85004 | United States | ||
| California Hearing and Balance Center |
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| Label | URL |
|---|---|
| Related Info | View source |
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| La Jolla |
| California |
| 92037 |
| United States |
| Shohet Ear Associates Medical Group | Newport Beach | California | 92663 | United States |
| Camino Ear, Nose and Throat Clinic | San Jose | California | 95138 | United States |
| Hearing Resource Center | San Mateo | California | 94401 | United States |
| The George Washington University- Department of Otolaryngology | Washington D.C. | District of Columbia | 20006 | United States |
| University of Miami, Miller School of Medicine | Miami | Florida | 33136 | United States |
| Physicians Choice Hearing and Dizziness Center | Tampa | Florida | 33613 | United States |
| Henry Ford Health System- Department of Otolayrngology and Audiology | Detroit | Michigan | 48202 | United States |
| New York Otology | New York | New York | 10021 | United States |
| Carolina Ear and Hearing Clinic, PC | Raleigh | North Carolina | 27612 | United States |
| Ear Medical Group | San Antonio | Texas | 78240 | United States |
| University Health Science Center (University of Utah Hospital) | Salt Lake City | Utah | 84132 | United States |
| ID | Term |
|---|---|
| D006314 | Hearing Loss, Conductive |
| 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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