510(k) K223911
K223911 is an FDA 510(k) premarket notification submitted by Intricon Corporation for the device "Lumen 155-SF". The FDA issued a decision of Substantially Equivalent on October 17, 2023. The device falls under product code QDD (Self-Fitting Air-Conduction Hearing Aid, Prescription), a Class II device regulated under 21 CFR 874.3325.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 17, 2023
- Date Received
- December 29, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Self-Fitting Air-Conduction Hearing Aid, Prescription
- Device Class
- Class II
- Regulation Number
- 874.3325
- Review Panel
- EN
- Submission Type
A self-fitting air-conduction hearing aid is a wearable sound amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fitting and settings. This is a prescription hearing aid.