# K081606: Baha Intenso

- Pathway: 510(k) (Traditional)
- Applicant: Cochlear Americas
- Decided: Aug 28, 2008 after 83 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: 4 generations back to K861971 (1986). 8 ancestors in all.
35 later devices descend from it; 3 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042017: Baha Divino, Entific Medical Systems, Inc. (2004) Summary page 2.

## Most influential descendants
- K090720: Cochlear Baha BP100 (2009), 33 descendants of its own
- K132278: Cochlear Baha  4 Sound Processor (2013), 11 descendants of its own
- K103594: Ponto Pro Power (2011), 11 descendants of its own
- K142907: Baha 5 Sound Processor (2015), 10 descendants of its own
- K132775: Ponto Plus and Ponto Plus Power (2013), 10 descendants of its own

## Indications for use
The Baha IntensoTM sound processor is intended for use with the Baha auditory osseointegrated implant or Baha Headband 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 hearing threshold (measured at 0.5, 1,2, and 3 kHz) should be better than or equal to 55 dB HL. * Bilateral fitting of the Intenso is intended for patients who meet the above criterion in both ears, with bilaterally symmetric moderate to severe conductive or mixed hearing loss. Symmetrical bone-conduction thresholds are defined as less than a 10 dB average difference between ears (measured at 0.5, 1, 2, and 3 kHz), or less than a 15 dB difference at individual frequencies. * Patients who suffer from unilateral sensorineural deafness in one ear with normal hearing in the other ear (i.e. single-sided deafness or "SSD"). Normal hearing is defined as a pure tone average air-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) of better than or equal to 20 dB HL. * Baha for SSD is also indicated for any patient who is indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.

Source page: https://510kreport.com/device/K081606
Methodology: https://510kreport.com/methodology