Earscan DSP-1 Pure Tone Audiometer
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K913589 FDA 510(k)
- FDA Product Code
- EWO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 874.1050 FDA 510(k)
- Regulation Number
- 874.1050 FDA 510(k)
- Advisory Committee
- Ear, Nose, Throat FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Earscan Dsp-1 Pure Tone Audiometer is a device used for hearing assessment that measures hearing thresholds at different frequencies. It is designed to perform both manual threshold exams and automatic hearing tests.
This device is manufactured by Micro Audiometrics Corp. and is supplied as a portable handheld instrument. It is authorized under FDA 510K clearance with product code EWO and is intended for use in ear, nose, and throat settings.
Frequently asked questions
What is the Earscan Dsp-1 Pure Tone Audiometer used for?
The Earscan Dsp-1 is a device used for hearing assessment that measures hearing thresholds at different frequencies. It is designed to perform both manual threshold exams and automatic hearing tests in ear, nose, and throat settings.
How is the Earscan Dsp-1 Pure Tone Audiometer supplied?
The device is supplied as a portable handheld instrument manufactured by Micro Audiometrics Corp. It is designed for ease of use in clinical environments where hearing assessments are conducted.
What is the regulatory status of the Earscan Dsp-1 Pure Tone Audiometer?
The device is authorized under FDA 510K clearance with product code EWO. It has been determined to be substantially equivalent to other devices in its class for hearing assessment purposes.
Can the Earscan Dsp-1 Pure Tone Audiometer be used for both manual and automatic testing?
Yes, the device is specifically designed to perform both manual threshold exams and automatic hearing tests, providing flexibility in hearing assessment methods depending on clinical needs.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Micro Audiometrics - Manufacturer of the Earscan Audiometer, PDF DSP Pure Tone Audiometer (DSPPTA) - Owner's Manual - Micro Aud, Dsp Pure Tone Handheld Audiometer - Audio-Digital.net
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K913589 | Class II | Active |
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Manufacturer
- Manufacturer
- Micro Audiometrics Corp.
Sources (1)
- FDA 510(k) K913589 24 fields · synced Sep 25, 2026