NOBELPHARMA BONE ANCHORED HEARING AID
Device Facts
| Record ID | K955713 |
|---|---|
| Device Name | NOBELPHARMA BONE ANCHORED HEARING AID |
| Applicant | Nobelpharma USA, Inc. |
| Product Code | LXB · Ear, Nose, Throat |
| Decision Date | Aug 9, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.3302 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
Intended Use
The BRÅNEMARK 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) - 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 conductive hearing loss due to ossicular disease and not appropriate for surgical correction or unable to be aided by conventional air conduction hearing devices. 2) 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 consideration 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 Biological - 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.
Device Story
System consists of titanium fixture implanted in temporal bone, abutment, and external sound processor. Fixture osseointegrates with bone; abutment provides percutaneous connection for sound processor. Processor converts sound to mechanical vibrations transmitted through abutment to skull bone, bypassing outer/middle ear to stimulate cochlea directly. Used in clinical settings by surgeons for implantation; patients or caregivers maintain abutment hygiene. Improves hearing for patients with conductive loss or anatomical malformations where conventional air-conduction aids are ineffective or contraindicated.
Clinical Evidence
No clinical data provided; substantial equivalence based on technological characteristics and comparison to predicate devices.
Technological Characteristics
Titanium fixture for osseointegration; percutaneous abutment; external sound processor. Mechanical bone conduction principle. Dimensions/form factor specific to temporal bone implantation. No software or electronic connectivity described.
Indications for Use
Indicated for patients >= 3 years old requiring hearing amplification with conductive hearing loss, congenital/acquired ear malformations (e.g., microtia), or chronic ear drainage preventing air-conduction aid use. Requires pure tone average bone conduction threshold <= 45 dB HL (Classic 300) or <= 60 dB HL (HC-220) and speech discrimination > 60%. Contraindicated if insufficient bone volume/quality or disease states jeopardizing osseointegration.
Regulatory Classification
Identification
A bone-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing and that conducts sound to the inner ear through the skull. The non-implantable components of a bone-conduction hearing aid, such as the external sound processor, are subject to the requirements in § 801.422 of this chapter.
Predicate Devices
- BRÄNEMARK SYSTEM® - Bone-Anchored Craniofacial Prosthetic Attachment System (K945154)
- Audiant Bone Conduction Hearing Aid (K861971)
- Audiant Bone Conduction Hearing Aid (K872168)
- Audiant Bone Conduction Hearing Aid (K841432)
Related Devices
- K121317 — COCHLEAR BAHA IMPLANT SYSTEM · Cochlear Americas · Oct 12, 2012
- K984162 — BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE · Nobelpharma USA, Inc. · Jun 28, 1999
- K100360 — BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENT · Cochlear Americas · Jul 13, 2010
- K082108 — OBC BONE ANCHORED HEARING AID SYSTEM · Oticon Medical AB · Nov 14, 2008
- K182116 — BA310 Abutment, BIA310 Implant/Abutment · Cochlear Americas · Dec 19, 2018
