Tympanic Membrane Direct Contact Hearing Aid
The Tympanic Membrane Direct Contact Hearing Aid (product code PLK) is a Class 2 ear, nose, and throat device intended to compensate for impaired hearing by transmitting amplified sound through a transducer placed in direct contact with the tympanic membrane, regulated under 874.3315. It requires 510(k) clearance and is flagged as an implant due to its direct tympanic membrane contact. The device is not life-sustaining.
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Basic Information
- Product Code
- PLK
- Device Class
- FDA class 2
- Regulation Number
- 874.3315
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K182480 | Earlens Contact Hearing Aid | Jan 25, 2019 | Substantially Equivalent | Earlens Corporation |
| K153634 | Wireless Earlens Light Driven Hearing Aid | Apr 06, 2016 | Substantially Equivalent | Earlens Corporation |
| DEN150002 | EarLens Contact Hearing Device | Sep 29, 2015 | Unknown | Earlens Corporation |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.