NOBELPHARMA BONE ANCHORED HEARING AID

• K Number: K955713
• Device Name: NOBELPHARMA BONE ANCHORED HEARING AID
• Manufacturer: NOBELPHARMA USA, INC.
• Date Cleared: 1996-08-09 ( 235 days)
• Product Code: LXB
• Regulation Number: 874.3302
• Type: Traditional
• Panel: EN
• Reference & Predicate Devices: K945154 , K861971 , K872168 , K841432

Intended 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:

• Otological 1)
• . 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.
• Anatomical and Biological 4)
• 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 Description

The BRANEMARK Bone-Anchored Hearing Aid (BAHA™) System includes a titanium fixture which is placed in the temporal bone just behind the ear, an abutment, various accessories necessary for the placement and use of the fixture/abutment pillar, and a sound processor which is attached to the abutment. The fixture/abutment pillar is used as an anchor for the sound processor.

AI/ML Overview

The provided text describes a medical device, the BRANEMARK Bone-Anchored Hearing Aid (BAHA™) System, and its intended use. However, it does not contain information about acceptance criteria, specific studies proving the device meets acceptance criteria, sample sizes for test or training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The document primarily focuses on:

• Device Name and Manufacturer: Nobelpharma USA, Inc., BRANEMARK Bone-Anchored Hearing Aid (BAHA™) System.
• Predicate Products: BRANEMARK SYSTEM® - Bone-Anchored Craniofacial Prosthetic Attachment System (K945154), Audiant Bone Conduction Hearing Aid (K861971, K872168 and K841432), and other bone conduction hearing aids.
• Device Description: A titanium fixture placed in the temporal bone, an abutment, accessories, and a sound processor.
• Intended Use: Bone-anchored, bone-conduction hearing aid for patients with specific otological, audiological, psychosocial, and anatomical/biological conditions.
• Comparison to Predicate: Stated that technological characteristics are "substantially identical and no additional questions regarding safety and effectiveness exist."

Therefore, I cannot fulfill your request for the specific details outlined in your prompt based on the provided text. The document is a "Summary of Safety and Effectiveness" from a 1995 FDA submission (K955713), which typically provides a high-level overview rather than detailed study results or performance data.

Regulation Number and Section

§ 874.3302 Bone-conduction hearing aid.

(a)
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.(b)
Classification. Class II.