# K992872: Branemark Bone-Anchored Hearing Aid (Baha) Cordelle II

- Pathway: 510(k) (Traditional)
- Applicant: Entific Medical Systems, Inc.
- Decided: Nov 24, 1999 after 90 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). 5 ancestors in all.
36 later devices descend from it; 1 cites 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)
- 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.
- K945154: BA-Cpas, Nobelpharma USA, Inc. (1995) Summary page 1.

## Most influential descendants
- K080363: Baha Cordelle II (2008), 35 descendants of its own
- 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

## Indications for use
This device is to be used by patients who have a conductive hearing loss and can still- benefit fiom sound amplification. Als indicated are paticuts with wixed heuing loss with average bone conduction thresholds in the indicated ear better than 45dB HL. The nominal output from the BAHA Cordelle Il is on average 13 dB stronger than the Classic 300 mode! (measured at 0,5,1,2,3 kHz). The Corddle is reconunended for patients having the same indications for the Classic 300 but where slightly stronger amplification is needed than what is delivered by the Classic 300 model. (Patients with bone conduction thresholds better than 45dB HL will be expectied 1o improve, but may not achieve levels in the normal range, Patients with a bone conduction threshaold where each standard measured frequency threshold is less than 25 dB HL can be cxpected to have restored hearing levels in the normal range.) The patients indicated for this device must also be unable to use conventional air conduction hearing aids or undergo ossicular replacement surgery because of one of the following: 1. Chronic otitis media (COM); or 2. Congenital malformation (CM) of the middle/external ear; or 3. Otber acquired malfunctions of the middle or external ear ¢anals which preclude the wearing of a conventional air conduction hearing aid. Additional indications to be met by perspective BAHA™Cordelle I candidates: 1. Patients (either by themselves or with the aid of others) must be able to maintain the abutment/skin interface of the BAHA Therefore, careful consideration must be given as to the patient’s psychological, physical, emotional and developmental capabilities to maintain hygiene. In the case of children part, but not all, of that responsibility falls on the parents or guardian. 2. For children and patients with coogenital malformations, sufficieat boae valume and bone quality must be present for a successful fixture implantation. Alternative treat- ment such as conventional bone conduction hearing aids, should be considered for patients having a discase state that might jeopardize asseointegration.

Source page: https://510kreport.com/device/K992872
Methodology: https://510kreport.com/methodology