| Device |
active implantable bone conduction hearing system |
| Regulation Description |
Active implantable bone conduction hearing system. |
| Definition |
An active implantable bone conduction hearing system is a prescription device consisting of an implanted transducer, implanted electronics components, and an audio processor. The active implantable bone conduction hearing system is intended to compensate for conductive or mixed hearing losses by conveying amplified acoustic signals to the cochlea via mechanical vibrations on the skull bone. |
| Physical State |
The device has an implantable component and an external audio processor component. Both components are made of different metals, alloys and/or plastic materials. |
| Technical Method |
Bone conduction implant that is surgically attached to the mastoid bone and an external audio processor that is held in place on the patient's scalp by magnetic attraction between the implant and the audio processor. The audio processor contains microphones that pick up sound and speech from the environment and convert them into a signal that can be transmitted across the skin to the implant. The signal transmitted by the Audio Processor is converted into controlled vibrations of the mastoid bone by the implant, which are perceived as sound. |
| Target Area |
The patient's hearing will be affected by this device. Since it is an implant on the patient's skull behind the ear, the areas of the skull and skin over the implant will be affected, including the ear. |
| Regulation Medical Specialty |
Ear Nose & Throat |
| Review Panel |
Ear Nose & Throat |
|---|
| Product Code | PFO |
|---|
| 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 |
874.3340
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
Yes
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
