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Etymonic Design Incorporated

US

Last updated May 31, 2026

What Etymonic Design Incorporated makes

Etymonic Design Incorporated manufactures audiometric testing devices, including mechanical bone vibrators and couplers for hearing aid evaluation, as well as skull simulators for calibration and diagnostic accuracy. Their products support hearing aid fitting and audiometric assessments by providing standardized test conditions and measurement tools.

The company’s portfolio consists of Class II medical devices, regulated under FDA requirements and listed in the FDA’s Unique Device Identification (UDI) system. These devices are intended for use in clinical and diagnostic settings to ensure precise hearing evaluations.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Etymonic Design Incorporated manufacture?

Etymonic Design Incorporated specializes in audiometric and hearing aid testing devices. Their products include mechanical bone vibrators, couplers for hearing aid evaluation, and skull simulators. These tools are designed to provide standardized conditions for accurate hearing assessments and calibration in clinical settings.

Where is Etymonic Design Incorporated based?

Etymonic Design Incorporated is headquartered in the United States. The company’s focus on audiometric and hearing aid testing devices aligns with regulatory frameworks in the US, including FDA requirements.

Which regulatory registries list Etymonic Design Incorporated’s devices?

Etymonic Design Incorporated’s devices are listed in the FDA’s Unique Device Identification (UDI) system. This registry ensures traceability and compliance tracking for Class II medical devices, which are subject to specific regulatory oversight.

How are Etymonic Design Incorporated’s devices classified under medical device regulations?

Etymonic Design Incorporated’s devices fall under Class II classification, which means they pose moderate risk and require compliance with FDA regulations, including performance standards and labeling requirements. This classification ensures their safety and effectiveness in audiometric testing and hearing aid evaluation.

What is the primary purpose of Etymonic Design Incorporated’s products in clinical settings?

The primary purpose of Etymonic Design Incorporated’s products is to support precise hearing aid fitting and audiometric assessments. Devices like the Verifit Skull Simulator and Audioscan Probe Tube provide controlled test environments, ensuring accurate measurements and calibration for diagnostic reliability.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Address
—
Website
audioscan.com
LinkedIn
—
Facebook
—
Phone
15192683313
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
244780581

Catalogue (5)

DeviceModel / ReferenceRegistriesClassStatus
Verifit Skull Simulator VA-300
FDA UDI
Class IIActive
Audioscan Probe Tube RE367
FDA UDI
Class IIActive
Audioscan Verifit VF-2
FDA UDI
Class IIActive
Audioscan RM500SL
FDA UDI
Class IIActive
Audioscan Axiom
FDA UDI
Class IIActive

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