Benchmark Ear Impression Techniques

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Benchmark Ear Impression Techniques

Conditions
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Ear Anatomy

Intervention / Treatment
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* Device: Standard Impression technique
* Device: Direct Ear Scanner


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Direct Ear Scanner<br>Digitale impression via direct ear scanner | Device: Direct Ear Scanner<br>* Direct Ear Scanner to scan the ear anatomy<br>|
| Active Comparator: Silicone Ear impression<br>Impression via silicone | Device: Standard Impression technique<br>* Silicone impression technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |