= FDA Import/Export Information =

  * Establishment (Manufacturer) Name: ''Audina Hearing Instrument''
  * Establishment (Manufacturer) Registration Number: ''1052698''
  * Establishment Operations: ''Contract Manufacturer; Manufacturer''
  * Owner/Operator Name: ''Audina Hearing Instrument''
  * Owner/Operator Number: ''9000174''
  * Regulation Number: ''874.3300''
  * Classification Name: ''Hearing Aid, Air Conduction''
  * Product Code: ''ESD''
  * Device Class: ''1''
  * Medical Specialty: ''Ear Nose & Throat''
  * Medical Device Listing (LST): ''E449176''
  * FDA Record: [[https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=47626&lpcd=ESD|Main]] and [[https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?rid=11708|Audina/Auditiva FDA Establishment Registration & Device Listing]]
  * Product (Proprietary Names): ''478 BTE; 478P BTE; 478P+ BTE; AGC-o; AUDINA; Audina 675DP+; Audina Analog +; Audina Arro 2; Audina Arro 6; Audina Arro 6AD; Audina BTE D6HP; Audina BTE D6P; Audina BTE6AD; Audina BTED275; Audina Flx 4; Audina Flx 6; Audina Intuition 6; Audina Intuition 6AD; Audina IRIC 6; Audina OCTANE T; BTE 13D2; BTE D2; BTE D2HP; BTE DP; Class A; Class D; Cue; ezHEAR; FLX; FLX 2; Foundation; InstaFit; Intellio; Intuition 12; Intuition 12AD; Intuition 2; Intuition 2+; Intuition 2ER; Intuition 2FC; Intuition 2FC+; Intuition 4+; Intuition 4AD; IRIC 12; IRIC 2; IRIC 4; nVe; nVe AD; Octane; Octane 12; Octane 4; Opti Trim; Push Pull; Simplex; Simplex 2; Simplex 2P; Simplex 2P+; Simplex FC; Sparo; Sparo 12; Sparo 2; Sparo 2+; Sparo 2ER; Sparo AD; Super 60D''.

== Importing Audina Products (for Returns) ==

^ Description ^ Value ^
| Commodity Harmonized Code | [9021.40.0000] Hearing Aids |
|  | [9021.90.0002] Hearing Aid Parts |

==== Audina (Non-wireless) ====
^ Description ^ Value ^
| FDA Establishment Number | 1052698 |
| FDA Medical Device Listing (LST) | E449176 |
| FDA Product Code | ESD: Air Conduction Hearing Aids |

==== Bernafon (Wireless) ====
^ Description ^ Value ^
| FDA Establishment Number | 3002857991 |
| FDA Medical Device Listing (LST) | D161232 |
| FDA Product Code | OSM: Air Conduction Hearing Aids with wireless technology|