Marcon Hearing Instruments, Inc.
United StatesFDA applicant, unverified
- Devices
- 10
What Marcon Hearing Instruments, Inc. makes
Marcon Hearing Instruments, Inc. manufactures behind-the-ear hearing instruments, including models such as the H37E, H37D, and H44-80. These devices are designed for amplifying sound for individuals with hearing loss, with variations like the CE-DM-II and H63 tailored for specific hearing needs. Additional models include the H54, H56, H58, and IM9, all categorized as behind-the-ear hearing aids.
The company’s portfolio consists of Class I hearing instruments, which are regulated under the FDA’s 510(k) clearance pathway. These devices are listed in the FDA’s 510(k) database as authorised medical devices. The manufacturer is based in the United States.
Catalogue
Model H 37E Ref K823468
Regimes: 510(k) Registry: 510(k)Behind-The-Ear, Model H37D Ref K790727
Regimes: 510(k) Registry: 510(k)Model Ce-Dm-Ii Hearing Instrument Ref K791126
Regimes: 510(k) Registry: 510(k)Model H44-80 Behind The Ear Hearing Ref K791745
Regimes: 510(k) Registry: 510(k)Model H63, Behind-The-Ear Ref K790870
Regimes: 510(k) Registry: 510(k)Behind-The-Ear Hearing Instrument, H54 Ref K790726
Regimes: 510(k) Registry: 510(k)Model H39C-Behing-The-Ear Hearing Instru Ref K790779
Regimes: 510(k) Registry: 510(k)Behind-The-Ear Hearing Instrument, H56 Ref K790700
Regimes: 510(k) Registry: 510(k)Model IM9 Ref K821042
Regimes: 510(k) Registry: 510(k)Model H58-Behind-The-Ear Hearing Instr. Ref K790697
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Marcon Hearing Instruments, Inc. have in the registry?
The registry currently lists 10 devices for Marcon Hearing Instruments, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Marcon Hearing Instruments, Inc.'s devices?
Among its 10 most recently registered devices, Marcon Hearing Instruments, Inc. has devices listed in FDA 510(k) (10 devices).
What risk classes do Marcon Hearing Instruments, Inc.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Marcon Hearing Instruments, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Marcon Hearing Instruments, Inc. in the registry?
The most recently registered devices listed for Marcon Hearing Instruments, Inc. include MODEL H 37E, BEHIND-THE-EAR, MODEL H37D, MODEL CE-DM-II HEARING INSTRUMENT and MODEL H44-80 BEHIND THE EAR HEARING.