Trutone
Country not established
- Devices
- 5
What Trutone makes
Trutone manufactures hearing aid accessories and programming devices, including telecoil (T-coil) programming units like the TWIST PPAGC-1 and SIBELMED AC50D, as well as audiometer-compatible programming tools such as the AUDIFON H20 PC and JAZZ PP AGC-O. Their portfolio also includes programmable power supplies (PP) and audiometer-compatible devices like the AUDIFON H24 AGC and H30 AGC for audiological testing and hearing aid adjustments.
The company’s devices are classified under FDA categories Class I and Class II, with several authorised via the 510(k) pathway. These products are primarily intended for use in audiological assessments and hearing aid programming, adhering to US regulatory standards. Trutone operates from the United States, where its devices are listed for commercial distribution.
Catalogue
Twist Ppagc-1, Twist Pp Ref K972543
510(k) 510(k)Sibelmed AC50D Ref K973377
510(k) 510(k)Audifon H20 Pc/Audifon H32 Pp Ref K972552
510(k) 510(k)Jazz Pp Agc-O, Jazz Pp Ref K972542
510(k) 510(k)Audifon H24 Agc/Audifon H25 Agc/Audifon H30 Agc Ref K972550
510(k) 510(k)
Frequently asked questions
How many devices does Trutone have in the registry?
The registry currently lists 5 devices for Trutone. Devices recorded under merged duplicate company entries are counted once.
Which registries list Trutone's devices?
Among its 5 most recently registered devices, Trutone has devices listed in FDA 510(k) (5 devices).
What risk classes do Trutone's devices fall under?
Among its 5 most recently registered devices, the classes recorded for Trutone's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Trutone in the registry?
The most recently registered devices listed for Trutone include TWIST PPAGC-1, TWIST PP, SIBELMED AC50D, AUDIFON H20 PC/AUDIFON H32 PP and JAZZ PP AGC-O, JAZZ PP.