Benchmark Ear Impression Techniques
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About
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.
Full description
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.
Enrollment
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Inclusion criteria
- Only adult participants ≥ 18 years
- Informed consent form as documented by signature
- Ability to fill in a questionnaire conscientious
- Healthy outer ear (Pinna and ear canal, w/o previous surgical procedures)
Exclusion criteria
- Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
Trial design
Primary purpose
Allocation
Interventional model
Masking
25 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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