Phonic Ear, Inc.
United StatesFDA applicant, unverified
- Devices
- 31
What Phonic Ear, Inc. makes
Phonic Ear, Inc. manufactures post-auricular hearing aids, including models such as the PE 805 SCD2, PE 475R, and PE 600CHD, as well as auditory trainers and FM receiver systems like the PE 485R and PE 150R. Their product line also includes standalone FM receivers and specialized hearing aid models like the PE 845-PPC and PE 400 series (IR, T, E variants).
The company’s devices are regulated under FDA’s Class I and Class II classifications, with many authorised via the 510(k) pathway. Products are listed in the FDA’s 510(k) registry, and the manufacturer operates from the United States.
Catalogue
Search and filter all 31 devicesFrequently asked questions
How many devices does Phonic Ear, Inc. have in the registry?
The registry currently lists 31 devices for Phonic Ear, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Phonic Ear, Inc.'s devices?
Among its 31 most recently registered devices, Phonic Ear, Inc. has devices listed in FDA 510(k) (31 devices).
What risk classes do Phonic Ear, Inc.'s devices fall under?
Among its 31 most recently registered devices, the classes recorded for Phonic Ear, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Phonic Ear, Inc. in the registry?
The most recently registered devices listed for Phonic Ear, Inc. include PHONIC EAR, POST-AURICULAR HEARING AID MODEL PE 805 SCD2, PHONIC EAR, MODEL PE475R and PHONIC EAR-PE 845-PPC.