Ototech, Ltd.
Country not established
- Devices
- 5
What Ototech, Ltd. makes
Ototech, Ltd. manufactures custom in-the-ear (ITE) and canal hearing aids, including linear and low-drive models with adjustable drainage and input compression features. These devices are designed for personalized hearing solutions tailored to specific ear canal shapes and user needs.
The company’s products fall under FDA Class I medical devices and are listed via the 510(k) pathway. Ototech, Ltd. is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Oto-Cem Ref K011338
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ototech, Ltd. have in the registry?
The registry currently lists 5 devices for Ototech, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ototech, Ltd.'s devices?
Among its 5 most recently registered devices, Ototech, Ltd. has devices listed in FDA 510(k) (5 devices).
What risk classes do Ototech, Ltd.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Ototech, Ltd.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ototech, Ltd. in the registry?
The most recently registered devices listed for Ototech, Ltd. include C ABRA MODEL LINEAR, LOW DR. CUSTOM CANAL HEAR AID, OTO-CEM, ABRA MODEL LINE LOW DRAIN CUST IN-THE-EAR HEAR AID and ABRA IPC MODEL INPUT COMPRES AGCCUST ITE HEAR AID.