Panels › Ear, Nose, Throat › Product code LXB · Class 2
Hearing Aid, Bone Conduction
Regulation 874.3302
4510(k)s in 12 months (53 all time)
0recalls in 12 months (7 all time)
7recalls that name a 510(k)
Top companies in LXB
| Company | 510(k)s | Recalls |
|---|---|---|
| Cochlear Americas | 12 | 2 |
| Oticon Medical AB | 8 | 0 |
| Sonitus Medical, Inc. | 2 | 5 |
| Xomed, Inc. | 6 | 0 |
| Entific Medical Systems, Inc. | 5 | 0 |
| Sophono, Inc. | 5 | 0 |
| Audifon-USA, Inc. | 1 | 0 |
| Bhm-Tech Produktionsgesellschaft Mbh | 1 | 0 |
| Cochlear | 1 | 0 |
| Cochlear Bone Anchored Systems AB | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 18, 2018 | Cochlear Americas Inc. Cochlear Baha 5 Sound Processor Tamper Proof Battery Door (3 pcs.) Terminated |
LXB | K142907 |
| Jun 2, 2014 | Cochlear Americas Inc. Cochlear Baha Soft tissue gauge 6mm.
Reusable instrument used to ensure the soft tissue thickness is equal to or less than 6 mm. For use with Baha Attract hearing system. Terminated |
LXB | K131240 |
| Mar 7, 2012 | Sonitus Medical Inc. SoundBite Hearing System; Microphone Tube Size 4. For use in patients with moderately severe, severe or profound sensorineural hearing loss in one ear and normal hearing in the other or patients with Terminated |
LXB | K110831 |
| Mar 7, 2012 | Sonitus Medical Inc. SoundBite Hearing System; Microphone Tube Size 3. For use in patients with moderately severe, severe or profound sensorineural hearing loss in one ear and normal hearing in the other or patients with Terminated |
LXB | K110831 |
| Mar 7, 2012 | Sonitus Medical Inc. SoundBite Hearing System; Microphone Tube Size 2. For use in patients with moderately severe, severe or profound sensorineural hearing loss in one ear and normal hearing in the other or patients with Terminated |
LXB | K110831 |
| Mar 7, 2012 | Sonitus Medical Inc. SoundBite Hearing System; Microphone Tube Size 1. For use in patients with moderately severe, severe or profound sensorineural hearing loss in one ear and normal hearing in the other or patients with Terminated |
LXB | K110831 |
| Mar 7, 2012 | Sonitus Medical Inc. SoundBite Hearing System; Microphone Tube Size 0. For use in patients with moderately severe, severe or profound sensorineural hearing loss in one ear and normal hearing in the other or patients with Terminated |
LXB | K110831 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.