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Clinical Performance Evaluation of 3D Ear Canal Scanning Technology

NCT05000047 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2023-06-01

Study results available
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Summary

Study participants will undergo ear canal impressions in a standard of care protocol utilizing two methodologies: 3D ear scanning using a commercially-available ear scanning device, and conventional silicone impression material. The elapsed time of each procedure will be captured for each participant, and the average duration of the two methodologies will be compared.

Conditions

  • Ear Mold Impression Procedure

Interventions

DEVICE

3D ear scanner

A commercially-available ear scanning device used according to standard of care. A hand-held device is used and is considered less invasive than conventional earmold impressions.

OTHER

Conventional silicon ear impressions

A two part silicon impression material that is used to fill the ear and produce a physical cast of the ear canal. The procedure is standard of care.

Sponsors & Collaborators

  • Sonova AG

    lead INDUSTRY

Principal Investigators

  • Kevin Seitz-Paquette · Sonova USCS

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-17
Primary Completion
2021-06-30
Completion
2021-07-15
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05000047 on ClinicalTrials.gov