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Miracle-Ear, Inc.

United StatesFDA applicant, unverified

Devices
65

What Miracle-Ear, Inc. makes

Miracle-Ear, Inc. manufactures behind-the-ear (BTE) and in-the-ear (ITE) hearing instruments, including models like the Dahlberg K-Amp BTE and Audiotone ITE Model ZD (XT). Their portfolio also includes hearing aids with optional wax guards, such as the Miracle Ear Model SK ITE and Sears Model 9094 ITE. Additional offerings include legacy models like the Sears Model LF9096 ITE and Dahlberg Model JH in-the-ear hearing instruments.

These devices are classified as Class I under FDA regulations and are supported by 510(k) clearance records. The company’s products are listed in the FDA’s 510(k) database. Miracle-Ear, Inc. is based in the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

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Frequently asked questions

How many devices does Miracle-Ear, Inc. have in the registry?

The registry currently lists 65 devices for Miracle-Ear, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Miracle-Ear, Inc.'s devices?

Among its 50 most recently registered devices, Miracle-Ear, Inc. has devices listed in FDA 510(k) (50 devices).

What risk classes do Miracle-Ear, Inc.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Miracle-Ear, Inc.'s devices are Class I. Each device page shows its own class and authorisation.

What are the newest devices from Miracle-Ear, Inc. in the registry?

The most recently registered devices listed for Miracle-Ear, Inc. include SEARS MODEL LF9096 IN-THE-EAR HEARING INSTRUMENT, DAHLBERG K-AMP BTE, AUDIOTONE MODEL A-96 and AUDIOTONE ITE HEARING AID MODEL ZD (XT).

Generated automatically from registry data and not verified by a human reviewer.