# K955713: Nobelpharma Bone Anchored Hearing Aid

- Pathway: 510(k) (Traditional)
- Applicant: Nobelpharma USA, Inc.
- Decided: Aug 9, 1996 after 235 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: 1 generation back to K861971 (1986). 3 ancestors in all.
45 later devices descend from it; 4 cite it directly.
0 of 49 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.
- 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.
- (no number) other bone conduction hearing aids: named in the summary without a submission number

## 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
- K984162: Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric Use (1999), 43 descendants of its own
- K021837: Branenmark Bone-Anchored-Hearing Aid (Baha) (2002), 40 descendants of its own
- 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

## Indications for use
The BRANEMARK Bone-Anchored Hearing Aid (BAHA™) System is intended to be used as a bone-anchored, bone-conduction hearing aid. The device is indicated for use in patients requiring hearing amplification and with the following conditions: 1) Otological congenital malformations of the external ear or microtia chronically draining ear which does not allow use of an air conduction hearing aid (e.g. external otitis, draining mastoid cavity) 2) other acquired malformations of the middle or external ear which preclude the wearing of a conventional hearing aid patients presently wearing, but dissatisfied with, traditional bone conduction hearing aids or patients who are satisfied with their bone conduction aids but could benefit from the features of the BAHA-type device. patients with conductivgfi hearing loss due to ossicular disease and not appropriate for surgical correction or unable to be aided by conventional air conduction hearing devices. Audiological Pure tone average bone conduction threshold of the indicated ear better than or equal to 45 dB HL for model, Classic 300 and 60 dB HL for model HC-220 (average 500, 1k, 2k and 3k Hz); and a speech discrimination score better than 60% or reasonably good speech discrimination as evaluated by a qualified audiologist, based on the patient's particular needs. 3) Psychosocial patients (either by themselves or with the aid of others) must be able to maintain the abutment/skin interface of the BAHA. Therefore, careful cofisidcmfion must be given as to the patient's psychological, physical, emotional and developmental capabilities to maintain hygiene. Patients should be at least 3 years of age. 4) Anatomical and Biologig*gl Biologically, titanium implants can be installed in most patients. Sufficient bone volume and bone quality should be present for a successful fixture implantation. Alternative treatments should be considered for patients having a disease state that might jeopardize osseointegration.

Source page: https://510kreport.com/device/K955713
Methodology: https://510kreport.com/methodology