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OpenTrials
Completed

NCT Number: NCT03303183

Benchmark Ear Impression Techniques

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.

Completed

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Key information

Conditions

Ear Anatomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sonova AG

Stäfa, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard Impression technique

Device

Silicone impression technique

Direct Ear Scanner

Device

Direct Ear Scanner to scan the ear anatomy

Primary outcomes

  1. Deviation of Direct ear scanner compared to silicone impressions

    Time frame: 1 year

    Deviation of the scan of Direct ear scanner compared to silicone impressions with two viscosities [mm]

Sponsors and collaborators

Lead sponsor

Sonova AG

Industry

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 5, 2017
Registry last updated
Nov 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.