# K090720: Cochlear Baha BP100

- Pathway: 510(k) (Traditional)
- Applicant: Cochlear Bone Anchored Systems AB
- Decided: Jun 17, 2009 after 91 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: 5 generations back to K861971 (1986). 16 ancestors in all.
33 later devices descend from it; 7 cite it directly.
0 of 50 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.
- K081606: Baha Intenso, Cochlear Americas (2008) Summary page 2.
- K080363: Baha Cordelle II, Cochlear Bone Anchored Systems AB (2008) Summary page 2.
- K973880: Sonix Hearing Aid Fitting and Programming System, Sonix Technologies, Inc. (1998) Summary page 2.
- K931372: Resound Portable Prescriptive Programming System, Resound Corp. (1993) Summary page 2.
- K942749: HI-Pro/Noah Universal Hearing Instrument, Madsen Electronics (Canada), Ltd. (1994) Summary page 2.
- K984547: Digital Lgob Procedure Using Resound, Digital 5000 Series Hearing Aids, Resound Corp. (1999) Summary page 2.

## Most influential descendants
- 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
- K161123: Baha 5 Power Sound Processor (2016), 6 descendants of its own

## Indications for use
The Cochlear Baha BP100 sound processor is intended for use with the Baha auditory osseointegrated implant (for children aged 5 and older, or adults), or with the Baha Headband or Baha Softband (no age limitations), 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 45 dB HL. * Bilateral fitting of the BP100 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/K090720
Methodology: https://510kreport.com/methodology