# K011438: Bilateral Fitting of the Branemark Bone-Anchored Hearing Aid (Baha) System.

- Pathway: 510(k) (Traditional)
- Applicant: Entific Medical Systems, Inc.
- Decided: Jul 23, 2001 after 74 days
- Product code: LXB (Hearing Aid, Bone Conduction)
- Device class: 2
- Regulation: 21 CFR 874.3302
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
40 later devices descend from it; 1 cites it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K042017: Baha Divino (2004), 39 descendants of its own
- K081606: Baha Intenso (2008), 35 descendants of its own
- K090720: Cochlear Baha BP100 (2009), 33 descendants of its own
- K082108: Obc Bone Anchored Hearing Aid System (2008), 19 descendants of its own
- K090996: Ponto Pro (2009), 18 descendants of its own

Source page: https://510kreport.com/device/K011438
Methodology: https://510kreport.com/methodology