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| Name | Class |
|---|---|
| Göteborg University | OTHER |
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This study will look at how much sound amplification (gain) different bone-anchored hearing devices can provide. The goal is to understand if there are differences between devices and whether these differences affect how well the devices meet the hearing needs of users.
Bone-anchored hearing systems send sound vibrations directly to the inner ear through a small implant in the skull. The amount of amplification a device can provide is important for people with hearing loss. However, the actual maximum amplification available to a user depends on feedback control during fitting and can vary between devices and individuals.
In this study, the actual maximum amplification of Device A and Device B will be compared. In addition the actual maximum amplification of Device A will be compared to Device C as well as the Device B compared to Device C. It will also be investigated whether the amplification limits the prescribed settings for the users.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All study participants | Experimental | All study patients will sequentially be measured with Device A, Device B and Device C |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bone Anchored Device A | Device | Fitting Device A |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in actual maximum gain in dB, between Device A compared to Device B for the mean average of the frequencies 500, 1000, 2000, 3000 and 4000 | Baseline, at fitting |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in actual maximum gain in dB, between Device A compared to Device B for the for the mean average of the frequencies 500, 1000, 2000 and 4000 | Baseline, at fitting | |
| Difference in actual maximum gain in dB, between Device A compared to Device B across frequencies 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 and 8000 kHz |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marianne Philipsson Senior Clinical Trial Manager | Contact | +46 (0)70 098 17 15 | maph@oticonmedical.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Göteborgs Universitet | Recruiting | Gothenburg | Sweden |
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| ID | Term |
|---|---|
| D046089 | Hearing Loss, Mixed Conductive-Sensorineural |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| Bone Anchored Device B |
| Device |
Fitting Device B |
|
| Bone Anchored Device C | Device | Fitting Device C |
|
| Baseline, at fitting |
| Difference in actual maximum gain in dB, between Device C compared to Device B for the mean average of the frequencies 500, 1000, 2000, 3000 and 4000 | Baseline, at fitting |
| Difference in actual maximum gain in dB, between Device C compared to Device B for the mean average of the frequencies 500, 1000, 2000 and 4000 | Baseline, at fitting |
| Difference in actual maximum gain in dB, between Device C compared to Device B across frequencies 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 and 8000 kHz | Baseline, at fitting |
| Number of subjects with a limitation of the prescribed gain in any frequency band with Device A, Device B and Device C | Baseline, at fitting |
| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |