# K984162: Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric Use

- Pathway: 510(k) (Traditional)
- Applicant: Nobelpharma USA, Inc.
- Decided: Jun 28, 1999 after 221 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: 2 generations back to K861971 (1986). 4 ancestors in all.
43 later devices descend from it; 2 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945154: BA-Cpas, Nobelpharma USA, Inc. (1995) Summary page 1.
- K955713: Nobelpharma Bone Anchored Hearing Aid, Nobelpharma USA, Inc. (1996) Summary page 1.
- K861971: Xomed Audiant Bone Conductor W/Improved AA Coil, Xomed, Inc. (1986) Summary page 1.
- K872168: Xomed Audiant Bone Conductor at the Ear Sound Pro., Xomed, Inc. (1987) Summary page 1.

## Cited in the summary but kept off the family tree
- K841432: Audiant™ Bone-Conduction Hearing Aid. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K042017: Baha Divino (2004), 39 descendants of its own
- K992872: Branemark Bone-Anchored Hearing Aid (Baha) Cordelle II (1999), 36 descendants of its own
- K081606: Baha Intenso (2008), 35 descendants of its own
- K080363: Baha Cordelle II (2008), 35 descendants of its own
- K090720: Cochlear Baha BP100 (2009), 33 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 from sound amplification- Also indicated are patients with mixed hearing loss with average bone conduction thresholds in the indicated ear better than 45 dB HL. (Patients with bone conduction thresholds between 25 and 45 dB HL will be expected to improve, but may not achieve levels in the normal range. Patients with a bone conduction threshold where each standard measured frequency threshold is less than 25 dB HL can be expected 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. Other acquired malfunctions of the middle or external ear canals which preclude the wearing of a conventional air conduction hearing aid. Additional indications to be met by perspective BAHA 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 congenital malformations, sufficient bone volume and bone quality must be present for a successful fixture implantation. Alternative treatment such as conventional bone conduction hearing aids, should be considered for patients having a disease state that might jeopardize osseointegration. Contraindications: 1. Speech discrimination scores of the indicated ear less the 60% at elevated sound pressure levels (SPL) during standardized tests. 2. Patients who are developmentally delayed or who suffer from drug abuse. (This includes children who have behavior problems or who have parents who are not able to keep the implanted area clean.) 3. Age less than 5 years. 4. Patients who already have a BAHA (i.e. no bilateral implants.) The BI-CROS attachment to the BAHA should be used for this purpose.

Source page: https://510kreport.com/device/K984162
Methodology: https://510kreport.com/methodology