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Qualitone

Also registered as Qualitone, Inc.

Country not established

Devices
40

What Qualitone makes

Qualitone manufactures hearing aids and audiometric devices, including behind-the-ear hearing aids such as the Qualitone Model 48 C-WR-Behind the Ear and Qualitone 48PP-AGC-I, as well as personal ear modules like the Module Personal Ear (Deluxe) and audiometers such as the Acoustic Appraiser CD-2 Audiometer/Master Hear.Aid. Other products include compression multisonic devices, adjustrettes, and various models of hearing assistance equipment under names like Elegance, AS-90, and Ultra & Ultra Miniature.

These devices are classified as Class I and Class II medical devices and are listed in the FDA 510(k) registry. Qualitone is based in the United States.

AI-generated from registry data, 30 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue40

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  • At-2 Ref K923007

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

  • Elegance Ref K812578

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

  • Acoustic Appraiser Cd-2 Audiometer/Master Hear.aid Ref K904544

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

  • As-90 Ref K923006

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

  • Compression Multisonic Ref K780241

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

  • Qualitone Model 48 C-Wr-Behind The Ear Ref K912154

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

  • Super X Adjustrette Ref K770251

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

  • Multisonic (Super) Code Tsm Ref K771069

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

  • Ultra & Ultra Minature Ref K843789

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

  • Module Personal Ear (Deluxe) Ref K790095

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

  • Qualitone 46PP-Agc-I Ref K913592

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

  • Qualitone 48PP-Agc-I, Behind The Ear Hearing Aid Ref K913781

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

  • Elegance - Deo, Modification Ref K911499

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

  • Compression Adjustrette Ref K760887

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

  • Module Personal Ear (Super) Ref K790093

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

  • Custom Personal Ear - Cpe Ref K911497

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

  • Canal Aid Ref K840165

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

  • In-The-Ear Ref K961827

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

  • Ultra & Ultra Lite Ii, Modification Ref K911504

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

  • Qualitone Ite Genesis Ref K904731

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

  • Behind-The-Ear Hearing Aid Model 46 Pp Pc Ref K892337

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

  • Acoustic Appraise Cd-3 Ref K923013

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

  • Quiltone Model 48 Pp-Agc-I-D-Behind The Ear Ref K912153

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

  • Cyber Iii Option Um, UC312, UC10, Ucic Ref K955359

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

  • Pro Fit-Cyber Ii Option Ref K935289

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

  • Cybernetic Option (Cyber I) Ref K923986

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

  • UC312, Ultra Miniature Itc Hearing Aid Ref K914017

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

  • Module Personal Ear (Compression) Ref K790094

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

  • Prophet Ref K953884

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

  • Qualitone Ultra Canal Genesis Ref K904730

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

  • Qualitone Stock Canal Aid Ref K851970

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

  • Adjustrette - Dao, Modification Ref K911498

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

  • Power Sonic Ref K810577

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

  • Behind-The-Ear Hearing Aid Model 48 Pp Pc Ref K892336

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

  • Behind-The-Ear Hearing Aid Model 48 Agci Ref K892338

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

  • Dynameq-Ii Option Ref K955466

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

  • Odyssey Clinical Audiometer Ref K935348

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

  • Multisonic (Deluxe) Code Tdm Ref K771029

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

  • The Canal (C.I.C.) Aka/Hidden Ear Ref K941107

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

  • Elegance - Ked, Behind The Ear Hearing Aid Ref K913771

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

Rows 1-40 of 40

Frequently asked questions

How many devices does Qualitone have in the registry?

The registry currently lists 40 devices for Qualitone. Devices recorded under merged duplicate company entries are counted once.

Which registries list Qualitone's devices?

Among its 40 most recently registered devices, Qualitone has devices listed in FDA 510(k) (40 devices).

What risk classes do Qualitone's devices fall under?

Among its 40 most recently registered devices, the classes recorded for Qualitone's devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Qualitone in the registry?

The most recently registered devices listed for Qualitone include AT-2, ELEGANCE, ACOUSTIC APPRAISER CD-2 AUDIOMETER/MASTER HEAR.AID and AS-90.

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