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Bernafon-Maico, Inc.

United StatesFDA applicant, unverified

Devices
9

What Bernafon-Maico, Inc. makes

Bernafon-Maico, Inc. manufactures a range of hearing aids, including completely-in-canal (CIC), in-the-canal (ITC), in-the-ear (ITE), and behind-the-ear (BTE) models. Their product line includes devices like the OPUS 2 series (CIC, ITC, and ITE), the MAICO MA25 Series II with speech processing, and the DUALINE 100 and 400 CIC variants. These devices are designed for customised hearing solutions tailored to individual patient needs.

The company’s devices are regulated under FDA Class I and Class II classifications, with authorisation via the 510(k) pathway. Products are listed in the FDA’s 510(k) registry. Bernafon-Maico, Inc. is based in the United States.

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

Catalogue9

Newest first, rows 1-9 of 9

  • Opus 2 - Completely-In-Canal Series (Cic) Ref K974152

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

  • Opus 2 - Full Concha Series - Ite Ref K974211

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

  • Maico MA42 Ref K982723

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

  • Dualine 100 Bte Ref K973948

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

  • Maico MA52 Ref K971080

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

  • Maico MA53 Ref K981142

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

  • Opus 2 - Canal Series (Itc) Ref K974069

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

  • Maico MA25 Series Ii With Speech Ref K962275

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

  • Dualine 400 Cic Ref K971158

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

Frequently asked questions

How many devices does Bernafon-Maico, Inc. have in the registry?

The registry currently lists 9 devices for Bernafon-Maico, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Bernafon-Maico, Inc.'s devices?

Among its 9 most recently registered devices, Bernafon-Maico, Inc. has devices listed in FDA 510(k) (9 devices).

What risk classes do Bernafon-Maico, Inc.'s devices fall under?

Among its 9 most recently registered devices, the classes recorded for Bernafon-Maico, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Bernafon-Maico, Inc. in the registry?

The most recently registered devices listed for Bernafon-Maico, Inc. include OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC), OPUS 2 - FULL CONCHA SERIES - ITE, MAICO MA42 and DUALINE 100 BTE.

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