510(k) DEN100025
DEN100025 is an FDA 510(k) premarket notification submitted by Office Research IN Clinical Amplifiction for the device "WIDEXLINK IN CLEAR SERIES HEARING AIDS". The FDA issued a decision of De Novo Granted on March 31, 2011. The device falls under product code OSM (Hearing Aid, Air-Conduction With Wireless Technology, Prescription), a Class II device regulated under 21 CFR 874.3305.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- March 31, 2011
- Date Received
- October 13, 2010
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hearing Aid, Air-Conduction With Wireless Technology, Prescription
- Device Class
- Class II
- Regulation Number
- 874.3305
- Review Panel
- EN
- Submission Type
A wireless air-conduction hearing aid is a wearable sound-amplifying device, intended to compensate for impaired hearing that incorporates wireless technology in its programming or use. This is a prescprition hearing aid.