Company
Audio Technologies
Founded by an ENT surgeon in 1976, Audio Technologies continuously develops new ideas, providing significant scientific improvements in ENT surgery.
Audio Technologies has been the first company to manufacture:
- Middle ear implant in dense hydroxylapatite
- Middle ear implant with platinum joint for flange angulation
- Non-adhesive PVA tampons with anatomic shape
- Titanium adjustable-length middle ear implants with porous hydroxylapatite head which don't need cartilage interposition
- Biomechanic middle ear implant
- External nasal splints with adjustable profile and selective side-pressure
- Internal nasal splints in polypropylene
- Universal / adjustable length suction tubes
Other than these unique products, Audio Technologies offers a catalogue of ENT medical devices such as drain tubes, reusable instruments, tampons and more.
The device manufactured by Audio Technologies belong to different regulatory classifications. The brand “Biosynth” is dedicated to the biological-derived grafts with destination of use different from ENT surgery.
|
Device |
CE class |
FDA class* |
|
Surgical instruments |
class I |
class I |
|
Nasal medications |
class I |
class I |
|
Disposable suction tubes |
class IIa |
class II |
|
PVA tampons |
class IIa |
class II |
|
Middle ear implants |
class IIb |
class III |
|
Equine cartilage grafts |
class III |
class IV |
|
Membranes in equine pericardium |
class III |
class IV |
It also boasts several international patents.
Currently the company gained the following certifications
-
“CE certification” complying to Annex IX of European Regulation 745/2017
-
“Quality Management System” complying to Annex IX of European Regulation 745/2017
-
Conformity certification to rules UNI EN ISO 13485
*Some devices might not be American-FDA registered. Contact us for updated details.