| Device |
tympanic membrane direct contact hearing aid |
| Regulation Description |
Tympanic membrane contact hearing aid. |
| 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. |
| 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 Medical Specialty |
Ear Nose & Throat |
| Review Panel |
Ear Nose & Throat |
|---|
| Product Code | PLK |
|---|
| Premarket Review |
Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
(OHT1)
Division of Dental and ENT Devices
(DHT1B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
874.3315
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
Yes
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
