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Radioear Corp.

United StatesFDA applicant, unverified

Devices
14

What Radioear Corp. makes

Radioear Corp. manufactures a range of hearing aids, including rechargeable and non-rechargeable models designed for various hearing loss profiles. Their portfolio includes devices such as the M410D, M430 PP, and RE Series, which cater to different user needs, from mild to moderate hearing impairment. Additional models like the 2010, M420H, and RM-L/C offer customizable features for personal hearing assistance.

These devices are classified under Class I in the U.S. regulatory framework and are listed via FDA 510(k) clearance. The company operates from the United States, adhering to U.S. medical device regulations.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

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  • Model M410D Hearing Aid Ref K834523

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Radioear M430 Pp Ref K841934

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Radioear Re Series Hearing Aids Ref K781458

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Hearing Aid-Model 2010 Ref K780667

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Radioear M420H Ref K841933

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Re-Hp Series Hearing Aids Ref K811522

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Radioear Model 2080 (Hearing Aid) Ref K800332

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Radioear Model Rm-L & Rm-C Hearing Aid Ref K800567

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Hearing Aid Model 440PPC Ref K841473

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Hearing Aid Model P500 Ref K841474

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Hearing Aid Model M400 Ref K841475

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Radioear, Personal Ref K760244

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Radioear Model 1072 Ref K770402

    Active Regimes: 510(k) Registry: 510(k) Class:—

  • Radioear Model Rei Hearing Aid Ref K800945

    Active Regimes: 510(k) Registry: 510(k) Class:I

Rows 1-14 of 14

Frequently asked questions

How many devices does Radioear Corp. have in the registry?

The registry currently lists 14 devices for Radioear Corp.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Radioear Corp.'s devices?

Among its 14 most recently registered devices, Radioear Corp. has devices listed in FDA 510(k) (14 devices).

What risk classes do Radioear Corp.'s devices fall under?

Among its 14 most recently registered devices, the classes recorded for Radioear Corp.'s devices are Class I. Each device page shows its own class and authorisation.

What are the newest devices from Radioear Corp. in the registry?

The most recently registered devices listed for Radioear Corp. include MODEL M410D HEARING AID, RADIOEAR M430 PP, RADIOEAR RE SERIES HEARING AIDS and HEARING AID-MODEL 2010.

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