# K021837: Branenmark Bone-Anchored-Hearing Aid (Baha)

- Pathway: 510(k) (Traditional)
- Applicant: Entific Medical Systems, Inc.
- Decided: Aug 30, 2002 after 87 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
Longest line of descent: 2 generations back to K861971 (1986). 4 ancestors in all.
40 later devices descend from it; 3 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955713: Nobelpharma Bone Anchored Hearing Aid, Nobelpharma USA, Inc. (1996) Summary page 2.
- (no number) Air conduction hearing aids with a CROS unit: named in the summary without a submission number

## 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

## Indications for use
The use of BAHA hearing aid for SSD is intended to improve speech recognition. The single sided deafness (SSD) indication for BAHA hearing aid is intended for patients who suffer from unilateral sensorineural deafness on one ear while the other ear has normal hearing. Normal hearing is defined as PTA AC threshold equal to or better than 20dB measured at 0.5, 1,2 and 3 kHz. BAHA for SSD is also indicated for patients who are indicated for an AC CROS but who for some reason cannot or will not use an AC CROS.

Source page: https://510kreport.com/device/K021837
Methodology: https://510kreport.com/methodology