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The purpose of this study is to determine the scan quality of the direct ear scanner concerning consistency, accuracy and reliability and to compare the data to common silicone ear impressions by benchmarking the outcome of each impression technique on custom product dummies on participants.
Today's standard for ear impression techniques is the impression taking process with silicone impression material. To use the silicone impression for a hearing aid manufacturing process the geometry of the impression is needed. Modern processes scan the silicone ear impression with specific scanners. Afterwards the digitalized ear impression is uploaded in the modeling software for further proceed. A new ear impression technique is now provided with the direct ear scanner technology. The direct ear scanner can create a digital scan of the outer ear and ear canal. The scan than can directly transferred to the modeling software. The research question of this study is to determine the scan quality of the direct ear scanner concerning consistency, accuracy and reliability and to compare the data to common silicone ear impressions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Direct Ear Scanner | Active Comparator | Digitale impression via direct ear scanner |
|
| Silicone Ear impression | Active Comparator | Impression via silicone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Impression technique | Device | Silicone impression technique |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Deviation of Direct ear scanner compared to silicone impressions | Deviation of the scan of Direct ear scanner compared to silicone impressions with two viscosities [mm] | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sonova AG | Stäfa | Switzerland |
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| Direct Ear Scanner |
| Device |
Direct Ear Scanner to scan the ear anatomy |
|