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Widex Hearing Aid Co., Inc.

United StatesFDA applicant, unverified

Devices
52

What Widex Hearing Aid Co., Inc. makes

The company manufactures a range of hearing aids, including in-the-canal (ITC) and in-the-ear (ITE) models such as the Adobe 100 series, as well as digital hearing aids like the WIDEX Model LOGO 8 (L8) and SENSO Digital (C9 and C16). It also produces custom-fit hearing aids and devices with integrated programs, such as the Zen Program for the MIND 440 hearing aid. Additional offerings include rechargeable and behind-the-ear (BTE) hearing aids, including the WIDEX Model D8 and G2H/G2T series.

These devices are regulated under the FDA’s 510(k) pathway, with most classified as Class I or Class II medical devices. The company’s products are listed in the FDA’s 510(k) clearance registry, and the manufacturer is based in the United States.

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

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  • Itc Model Adobe 100 Canal Ref K931591

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

  • Widex Model Dx Hearing Aid Ref K930715

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

  • Zen Program (Mind 440 Hearing Aid) Ref K080955

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

  • Widex Model Logo 8 (L8) Ref K933644

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

  • Widex Model Senso Digital (C9) Ref K965254

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

  • Widex Model Logo 6 (L6) Ref K933643

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

  • Widex Model D8 (Hearing Aid) Ref K926244

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

  • Ite Model Adobe 100 Full Custom Ref K931590

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

  • Widex Hearing Aid #G2H & G2T Ref K830465

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

  • Widex Model Senso Digital (C16) Ref K955879

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

  • Lx-Itc Ref K946071

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

  • Widex Hearing Aid Model Es 10 Asp T Ref K895982

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

  • Compass Software Module Ref K944097

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

  • Adobe C.I.C Ref K943016

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

  • Hearing Aid Model A8H And A8T Ref K770689

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

  • Widex Model Lx-Ite Ref K944838

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

  • Widex Model D16 Ref K926085

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

  • Widex Hearing Aid Model L1 Ref K832376

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

  • Widex Hearing Aid Model 820 Ref K792567

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

  • Models G6H, G6T, G1H & G1T Ref K823460

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

  • Widex Hearing Aid Model The Discovery Ref K901642

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

  • Widex Hearing Aid Model F7H & F7T Ref K761103

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

  • Widex Model D32 Ref K922708

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

  • Widex Bte Hearing Aid Model Q16 With Remote Ref K897033

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

  • Widex R.C. 2 (Remote Control) Ref K935424

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

  • Widex Model Senso Digital (C8) Ref K955878

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

  • Widex Hearing Aid Model S10 Ref K792389

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

  • Widex Model Logo 12 (L12) Ref K933640

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

  • Widex Senso Digital (Cic) Ref K970904

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

  • Hearing Aid #G6H & G6T Ref K823431

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

  • Hearing Aid Model F8H Anl F8T Ref K770688

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

  • Widex S-21 Ref K941508

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

  • Widex Model Logo 32 (L32) Ref K952229

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

  • Widex Hearing Aid Model C1 Ref K880273

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

  • Widex Hearing Aid Model ES1 Ref K872374

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

  • Audilens Llk Ref K943706

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

  • Widex Model Q9, Bte W/Quatro Remote Control Ref K901316

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

  • Widex Senso Digital (Px) Ref K954526

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

  • Widex Model Q12 Bte With Quatro Remote Control Ref K901317

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

  • Hearing Aid Widex Bte Ref K884113

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

  • Widex Model M1 Ref K853793

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

  • Widex Senso Digital (Mini Canal) Ref K971535

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

  • Hearing Aid G3H & G3T Ref K832129

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

  • Widex Hearing Aid Model ES2 Ref K864097

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

  • Widex Hearing Aid Model F8 Ref K761223

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

  • Widex Hearing Aid Models ES9T And ES9H Ref K895981

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

  • Widex Model Qx In-The-Ear Hearing Aid Ref K912169

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

  • Widex Bte Hearing Aid Model Q8 Ref K885128

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

  • Senso Digital (C18) Ref K965218

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

  • Widex Model Logo 8S Ref K944518

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

Rows 1-50 of 52

Showing 1-50 of 52

Frequently asked questions

How many devices does Widex Hearing Aid Co., Inc. have in the registry?

The registry currently lists 52 devices for Widex Hearing Aid Co., Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Widex Hearing Aid Co., Inc.'s devices?

Among its 50 most recently registered devices, Widex Hearing Aid Co., Inc. has devices listed in FDA 510(k) (50 devices).

What risk classes do Widex Hearing Aid Co., Inc.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Widex Hearing Aid Co., Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Widex Hearing Aid Co., Inc. in the registry?

The most recently registered devices listed for Widex Hearing Aid Co., Inc. include ITC MODEL ADOBE 100 CANAL, WIDEX MODEL DX HEARING AID, ZEN PROGRAM (MIND 440 HEARING AID) and WIDEX MODEL LOGO 8 (L8).

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