Identifiers
- 510(k) Number
- K151025 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 iHearTest is an Audiometer, a device used for hearing screening. It is classified as a device with a regulation number of 874.1050 and is used in the medical specialty of Ear, Nose, Throat.
The iHearTest is supplied as a tool for baseline hearing screening and annual screening. It is available online or at select retail pharmacies across the U.S. and is intended for use in settings such as at home. The device has been authorized with an FDA 510K clearance.
Frequently asked questions
What is the iHearTest used for?
The iHearTest is used for baseline hearing screening and annual screening, providing a tool for assessing hearing in various settings, including at home.
Is the iHearTest available for purchase online or in stores?
Yes, the iHearTest is available online or at select retail pharmacies across the U.S., making it easily accessible for those who need it.
What type of clearance does the iHearTest have?
The iHearTest has been authorized with an FDA 510K clearance, indicating that it has been found to be substantially equivalent to other devices on the market.
In what medical specialty is the iHearTest used?
The iHearTest is used in the medical specialty of Ear, Nose, Throat, providing a valuable tool for healthcare professionals in this field.
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: iHEAR® Medical Launches Free @Home Hearing Test, iHear Medical - Crunchbase Company Profile & Funding, Ihear Medical Inc, IHEAR IHEARTEST USER MANUAL Pdf Download | ManualsLib
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K151025 | Class II | Active |
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Manufacturer
- Manufacturer
- Ihear Medical, Inc.
Sources (1)
- FDA 510(k) K151025 24 fields · synced Sep 28, 2026