Vibrant Soundbridge System
by MED-EL Elektromedizinische Geräte GmbH
PMA P990052
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP990052 | Date31 Aug 2000 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade Name
- Vibrant P/ Vibrant D Soundbridge System
- Generic Name
- Implant, hearing, active, middle ear, partially implanted
- FDA applicant
- Med-El Elektromedizinische Gerate GmbH
- PMA Number
- FDA Product Code
- MPV
- Device Class
- Class III
- Advisory Committee
- Ear, Nose, Throat
- FDA Decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The Vibrant Soundbridge System is a partially implanted active middle ear hearing implant designed to provide mechanical stimulation of the ossicles for sound perception. It is classified as an Implant, Hearing, Active, Middle Ear, Partially Implanted and is intended for adults aged 18 years or older with moderate to severe sensorineural hearing loss who seek an alternative to acoustic hearing aids.
The device is supplied as a partially implanted system and requires prior experience with appropriately fitted hearing aids. It is approved under FDA PMA (P990052) and is categorized under product code MPV. The system is not described as single-use or reusable in the specifications, and no details regarding sterility, MRI safety, or storage conditions are provided.
Other devices from MED-EL Elektromedizinische Geräte GmbH
See all devices from MED-EL Elektromedizinische Geräte GmbH →
Questions
AI-generated answers, 18 Sep 2026
Who is the Vibrant Soundbridge System intended for, and what makes it different from traditional hearing aids?
The Vibrant Soundbridge System is intended for adults aged 18 or older with moderate to severe sensorineural hearing loss who prefer an alternative to acoustic hearing aids. Unlike traditional hearing aids, which amplify sound acoustically, this device provides mechanical stimulation of the ossicles via a partially implanted system, offering a different approach to sound perception for eligible patients.
What prior experience or preparation is required before using the Vibrant Soundbridge System?
The system requires that the patient have prior experience with appropriately fitted hearing aids. This ensures they understand how to manage hearing solutions before transitioning to the Vibrant Soundbridge, which is a more complex, partially implanted alternative.
How is the Vibrant Soundbridge System supplied, and what models are available?
The device is supplied as a partially implanted system under the trade names **Vibrant P** and **Vibrant D Soundbridge System**. These models are designed to be implanted in the middle ear, with external components for sound processing and transmission.
Is there any information provided about the regulatory approval process for this device?
The Vibrant Soundbridge System holds FDA approval under **PMA (P990052)**, indicating it underwent a Premarket Approval process. This classification is for Class III devices, reflecting its higher-risk nature due to implantation. The approval specifies its intended use for adults with moderate to severe sensorineural hearing loss.