# K080363: Baha Cordelle II

- Pathway: 510(k) (Traditional)
- Applicant: Cochlear Bone Anchored Systems AB
- Decided: Apr 10, 2008 after 59 days
- Product code: MAH (Hearing Aid, Bone Conduction, Implanted)
- 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). 6 ancestors in all.
35 later devices descend from it; 4 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992872: Branemark Bone-Anchored Hearing Aid (Baha) Cordelle II, Entific Medical Systems, Inc. (1999) 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 Cordelle II sound processor is intended for use with the Baha auditory osseointegrated implant 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 65 dB HL. Bilateral fitting of the Cordelle II 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/K080363
Methodology: https://510kreport.com/methodology