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.

Study Overview

• Status: Completed
• Conditions: Ear Anatomy
• Intervention / Treatment: Device: Direct Ear Scanner; Device: Standard Impression technique

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Stäfa, Switzerland
    • Sonova AG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sonova AG

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2017
• Primary Completion (Actual): December 15, 2018
• Study Completion (Actual): December 15, 2018

Study Registration Dates

• First Submitted: October 2, 2017
• First Submitted That Met QC Criteria: October 2, 2017
• First Posted (Actual): October 5, 2017

Study Record Updates

• Last Update Posted (Actual): November 26, 2019
• Last Update Submitted That Met QC Criteria: November 25, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: KEK-ZH Nr.2014-0326

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No