Cochlear Laboratories, Ltd.
Country not established
- Devices
- 1
What Cochlear Laboratories, Ltd. makes
Cochlear Laboratories, Ltd. manufactures custom-fitted in-the-ear and canal hearing aids designed for individual patient needs, tailored to fit within the ear canal or behind it.
These devices are classified as Class I under regulatory frameworks and are listed via the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Custom In-The-Ear And Canal Hearing Aid Ref K862754
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Cochlear Laboratories, Ltd. have in the registry?
The registry currently lists 1 device for Cochlear Laboratories, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cochlear Laboratories, Ltd.'s devices?
Among its 1 most recently registered device, Cochlear Laboratories, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Cochlear Laboratories, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Cochlear Laboratories, Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Cochlear Laboratories, Ltd. in the registry?
The most recently registered devices listed for Cochlear Laboratories, Ltd. include CUSTOM IN-THE-EAR AND CANAL HEARING AID.