# LXB: Hearing Aid, Bone Conduction

- Device class: 2; regulation: 21 CFR 874.3302; FDA's rule: 510(k) required
- FDA decisions: 53
- 510(k) review time 2021–2025: median 104 days (middle half 77–189)
- Recalls: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2012: 1
- 2013: 5
- 2015: 2
- 2016: 4
- 2017: 1
- 2018: 1
- 2019: 1
- 2021: 4
- 2025: 2
- 2026: 4

## Most-cited predicates
- K090720: Cochlear Baha BP100 (2009), cited by 7
- K042017: Baha Divino (2004), cited by 5
- K955713: Nobelpharma Bone Anchored Hearing Aid (1996), cited by 4
- K142907: Baha 5 Sound Processor (2015), cited by 4
- K090996: Ponto Pro (2009), cited by 3
- K081606: Baha Intenso (2008), cited by 3
- K100360: BIA300 Series Implant and Abutment, BI300 Implant, BA300 Abutment (2010), cited by 3
- K861971: Xomed Audiant Bone Conductor W/Improved AA Coil (1986), cited by 3
- K161671: Ponto 3, Ponto 3 Power and Ponto 3 SuperPower (2016), cited by 3
- K121793: AN Evo 1, CS Evo 1, Contact Mini, Apollon (2012), cited by 3

Source page: https://510kreport.com/product-code/LXB
Data by year (CSV): https://510kreport.com/product-code/LXB.csv