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Hearing Tech, Inc.

United StatesFDA applicant, unverified

Devices
11

What Hearing Tech, Inc. makes

Hearing Tech, Inc. manufactures a range of hearing aids, including custom in-the-ear models (such as the ESCORT EC and ESCORT ITC), behind-the-ear (BTE) devices (e.g., the 543 Series), and intermediate canal (ITC) types (including the Heritage III and HEARTECH Model Illusion). The company also produces the HEARTECH HFX hearing aid and legacy models like the HEARTECH Model CH. Additionally, it supplies the ROTABLATOR rotational angioplasty system, a device used in vascular procedures.

The company’s products are regulated under the FDA’s 510(k) pathway, with devices classified as Class I and Class II. Hearing aids fall under Class II, while the ROTABLATOR system is classified as Class I. These devices are listed in the FDA’s 510(k) registry. Hearing Tech, Inc. is headquartered in the United States.

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

Catalogue11

Newest first, rows 1-11 of 11

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  • Escort Ec Custom In-The-Ear Hearing Aid Ref K870350

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

  • Escort Itc Ref K903295

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

  • Heartech Model(Htc) (Heritage) Ref K853218

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

  • 543 Series Bte Ref K905680

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

  • Rotablator Rotational Angioplasty System Ref K924712

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

  • Heartech Model Ch Ref K853219

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

  • Heritage Iii (Htc) Itc Type Hearing Aid Ref K903023

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

  • Heartech Model Illusion Ref K853220

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

  • Hearing Tech Ref K941587

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

  • Heartech Model In Tech Ref K854315

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

  • Heartech Hfx, Hearing Aid Ref K870723

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

Rows 1-11 of 11

Frequently asked questions

How many devices does Hearing Tech, Inc. have in the registry?

The registry currently lists 11 devices for Hearing Tech, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Hearing Tech, Inc.'s devices?

Among its 11 most recently registered devices, Hearing Tech, Inc. has devices listed in FDA 510(k) (11 devices).

What risk classes do Hearing Tech, Inc.'s devices fall under?

Among its 11 most recently registered devices, the classes recorded for Hearing Tech, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Hearing Tech, Inc. in the registry?

The most recently registered devices listed for Hearing Tech, Inc. include ESCORT EC CUSTOM IN-THE-EAR HEARING AID, ESCORT ITC, HEARTECH MODEL(HTC) (HERITAGE) and 543 SERIES BTE.

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