Identity
- Trade Name
- SOUNDTEC DIRECT SYSTEM FDA PMA
- Generic Name
- Implant, hearing, active, middle ear, partially implanted FDA PMA
Identifiers
- PMA Number
- P010023 FDA PMA
- FDA Product Code
- MPV FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Ear, Nose, Throat FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Soundtec Direct System is an active, partially implanted middle ear hearing implant designed to assist with auditory function. It serves as an alternative to traditional acoustic hearing aids for individuals seeking different amplification solutions.
This device is indicated for use in adults 18 years of age or older who have moderate to severe sensorineural hearing loss. It is recommended that patients have prior experience with appropriately fitted hearing aids before receiving the implant. The system is authorized under FDA PMA P010023.
Frequently asked questions
Who is the intended candidate for the Soundtec Direct System?
The device is intended for adults 18 years of age or older who have been diagnosed with moderate to severe sensorineural hearing loss and are looking for an alternative to acoustic hearing aids.
Is prior hearing aid experience required before using this device?
Yes, it is recommended that individuals have experience with appropriately fitted hearing aids before receiving the Soundtec Direct System to ensure they are suitable candidates for this specific technology.
What type of device is the Soundtec Direct System?
It is classified as an active, partially implanted middle ear hearing implant, which functions by directly stimulating the middle ear structures to improve hearing.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P010023 | Class III | Active |
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Manufacturer
- Manufacturer
- Ototronix, LLC
Sources (1)
- FDA PMA P010023 24 fields · synced Sep 18, 2026