PLK — Tympanic Membrane Direct Contact Hearing Aid Class II
FDA product code PLK covers "Tympanic Membrane Direct Contact Hearing Aid", a Class II medical device regulated under 21 CFR 874.3315. Submissions are reviewed by the Ear, Nose, Throat panel. Devices under this code are implants. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PLK
- Device Class
- Class II
- Regulation Number
- 874.3315
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- Yes
Definition
A tympanic membrane contact hearing aid is intended to compensate for impaired hearing by transmitting amplified sound by vibrating the tympanic membrane through a transducer that is in direct contact with the tympanic membrane.