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.
| Device Type ID | 1639 |
| Device Name | Tympanic Membrane Direct Contact Hearing Aid |
| Physical State | A Tympanic Membrane Contact Hearing Aid Consists Of An Externally Worn Audio Processor, And A Custom Fitted Tympanic Membrane Receiver/transducer. |
| Technical Method | A Tympanic Membrane Contact Hearing Aid Is A Device Worn By The Patient That Uses An External Audio Processor To Transmit Amplified Sound By Vibrating The Tympanic Membrane Through A Transducer That Is In Direct Contact With The Tympanic Membrane |
| Target Area | A Tympanic Membrane Contact Hearing Aid Provides Direct, Mechanical Vibration Of The Lateral Side Of The Tympanic Membrane. |
| Regulation Description | Tympanic Membrane Contact Hearing Aid. |
| Regulation Medical Specialty | Ear Nose & Throat |
| Review Panel | Ear Nose & Throat |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Ear, Nose, And Throat Devices Branch (ENTB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 874.3315 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PLK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1639 |
| Device | Tympanic Membrane Direct Contact Hearing Aid |
| Product Code | PLK |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Tympanic Membrane Contact Hearing Aid. |
| CFR Regulation Number | 874.3315 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
EARLENS CORPORATION | ||
GRANTED | 1 | |
SUBSTANTIALLY EQUIVALENT | 2 | |