Benchmark Ear Impression Techniques

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03303183

Enrollment

Registered

2017-10-05

Start date

2017-10-23

Completion date

2018-12-15

Last updated

2019-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ear Anatomy

Brief summary

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

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.

Interventions

DEVICEStandard Impression technique

Silicone impression technique

DEVICEDirect Ear Scanner

Direct Ear Scanner to scan the ear anatomy

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Deviation of Direct ear scanner compared to silicone impressions	1 year	Deviation of the scan of Direct ear scanner compared to silicone impressions with two viscosities \[mm\]

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026