Benchmark Ear Impression Techniques

• Sponsor: Sonova AG (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03303183
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Arms: 2
• Actual Duration (Months): 13.7
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ear Anatomy	Device: Standard Impression technique; Device: Direct Ear Scanner	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 25 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: Benchmark Ear Impression Techniques
• Actual Study Start Date: Oct 23, 2017
• Actual Primary Completion Date: Dec 15, 2018
• Actual Study Completion Date: Dec 15, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sonova AG	Stäfa		Switzerland

Sponsors and Collaborators

• Sonova AG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sonova AG
• ClinicalTrials.gov Identifier: NCT03303183
• Other Study ID Numbers: KEK-ZH Nr.2014-0326
• First Posted: Oct 5, 2017
• Last Update Posted: Nov 26, 2019
• Last Verified: Nov 1, 2019

• 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

Study Results

No Results Posted as of Nov 26, 2019