# K042017: Baha Divino

- Pathway: 510(k) (Traditional)
- Applicant: Entific Medical Systems, Inc.
- Decided: Aug 26, 2004 after 30 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: 3 generations back to K861971 (1986). 7 ancestors in all.
39 later devices descend from it; 5 cite it directly.
0 of 47 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 1.
- K984162: Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric Use, Nobelpharma USA, Inc. (1999) Summary page 1.
- K011438: Bilateral Fitting of the Branemark Bone-Anchored Hearing Aid (Baha) System., Entific Medical Systems, Inc. (2001)
- K021837: Branenmark Bone-Anchored-Hearing Aid (Baha), Entific Medical Systems, Inc. (2002) Summary page 1.
- (no number) Air conduction hearing aids with digital sound processing: named in the summary without a submission number

## Most influential descendants
- 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
- K132278: Cochlear Baha  4 Sound Processor (2013), 11 descendants of its own

## Indications for use
The BAHA Divino is intended for the following patients and indications: - Patients who have a conductive or mixed hearing loss and can still benefit from sound amplification. The pure tone average bone conduction threshold should be better than or equal to 45 dB HL (measured at 0.5, 1, 2 and 3 kHz) - Bilateral fitting of the Divino is intended for patients who suffer from moderate to severe bilateral symmetric conductive and/or mixed hearing losses. Symmetric bone conductive thresholds are defined as less than 10 dB in average (measured at 0.5, 1, 2 and 4 kHz) or less than 15 dB at individual frequencies - The single sided deafness (SSD) indication for the Divino 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/K042017
Methodology: https://510kreport.com/methodology