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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
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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
| Description | Value |
| FDA Establishment Number | 1052698 |
| FDA Medical Device Listing (LST) | E449176 (Non-wireless) |
| FDA Product Code | ESD: Air Conduction Hearing Aids (Non-wireless) |
Bernafon
| Description | Value |
| FDA Establishment Number | 3002857991 |
| FDA Medical Device Listing (LST) | Bernafon: D161232 (Wireless) |
| FDA Product Code | OSM: Air Conduction Hearing Aids with wireless technology (Wireless) |