Beltone Electronics Corp.
United StatesFDA applicant, unverified
- Devices
- 42
What Beltone Electronics Corp. makes
Beltone Electronics Corp. manufactures a range of hearing aids, including behind-the-ear (BTE) models like the BELTONE COMPOSER 2000 and OPRA CLEAR VOICE-K, as well as custom in-the-ear (ITE) and in-the-canal (ITC) devices such as the BELTONE OPTIMA 2000 CLEARVOICE SERIES and OPERA LOR. Their portfolio also includes rechargeable and power assist products, such as the BELTONE ULTIMA 80 and OTOSONIC POWER PAS, alongside diagnostic tools like the BELTONE AUDIO SCOUT and cleaning systems like the OTOSONIC CF-2 series. Additional offerings include the BELTONE INVISA and BELTONE PRIMA 2000, designed for various hearing loss profiles.
The company’s devices are classified under FDA categories Class I and Class II, with many products listed via the 510(k) pathway. These devices are intended for use in the United States, where regulatory compliance is required for market distribution. Beltone Electronics Corp. is headquartered in the US.
Catalogue
Search and filter all 42 devicesFrequently asked questions
How many devices does Beltone Electronics Corp. have in the registry?
The registry currently lists 42 devices for Beltone Electronics Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Beltone Electronics Corp.'s devices?
Among its 42 most recently registered devices, Beltone Electronics Corp. has devices listed in FDA 510(k) (42 devices).
What risk classes do Beltone Electronics Corp.'s devices fall under?
Among its 42 most recently registered devices, the classes recorded for Beltone Electronics Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Beltone Electronics Corp. in the registry?
The most recently registered devices listed for Beltone Electronics Corp. include BELTONE COMPARAFIT, OTOSONIC CF-2, CF-2 IC, CF-2 ANF, CF-2 WITH IMPROVED CLASS D (DELTA AMP), BELTONE OPTIMA 2000 CLEARVOICE SERIES, IN-THE-EAR and THE BELTONE AUDIO SCOUT.