Question 1

What types of medical devices does Ihear Medical, Inc. manufacture?

Accepted Answer

Ihear Medical, Inc. specializes in air-conduction hearing aids and their associated wearable cases. These include rechargeable or disposable hearing aids, as well as diagnostic tools like hearing test devices used in clinical settings. Their focus is on devices that support hearing assessment and assistance.

Question 2

Where is Ihear Medical, Inc. based?

Accepted Answer

Ihear Medical, Inc. is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework, as it operates under FDA guidelines.

Question 3

Which regulatory registries list Ihear Medical, Inc.’s devices?

Accepted Answer

Ihear Medical, Inc.’s devices are listed in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identifier (UDI) system. These registries help track and identify their Class II devices, ensuring compliance with U.S. medical device regulations.

Question 4

How are Ihear Medical, Inc.’s devices classified under FDA regulations?

Accepted Answer

Ihear Medical, Inc.’s devices fall under Class II classification by the FDA. This classification typically applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as hearing aids and diagnostic tools.

Device	Model / Reference	Registries	Class	Status
iHear EON	EON-KIT-STD	FDA UDI	Class II	Active
iHearTest	K151025	FDA 510(k)	Class II	Active

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