(235 days)
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No
The provided text describes a bone-anchored hearing aid system and its components, intended use, and predicate devices. There is no mention of AI, ML, or any related technologies in the description or other sections.
Yes
The device is intended to be used as a bone-anchored, bone-conduction hearing aid for patients requiring hearing amplification due to various otological and audiological conditions, which directly addresses a health condition.
No
The device is described as a hearing aid intended for amplification, not for diagnosing conditions. Its primary function is to provide sound rather than to identify or assess a medical condition.
No
The device description explicitly states that the system includes a titanium fixture, an abutment, accessories, and a sound processor, all of which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The BRANEMARK Bone-Anchored Hearing Aid (BAHA™) System is a medical device that is surgically implanted and uses bone conduction to transmit sound and improve hearing. It does not analyze biological samples.
- Intended Use: The intended use describes the device's purpose as a hearing aid for specific hearing conditions. This is a therapeutic and assistive function, not a diagnostic one.
- Device Description: The description details the physical components of the device (fixture, abutment, sound processor) and how they function to aid hearing. There is no mention of analyzing biological samples.
Therefore, the BRANEMARK Bone-Anchored Hearing Aid (BAHA™) System falls under the category of a surgically implanted medical device for hearing assistance, not an in vitro diagnostic.
N/A
Intended Use / 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:
- 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.
-
- 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.
-
- 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.
- 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.
Product codes
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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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
temporal bone just behind the ear
Indicated Patient Age Range
Patients should be at least 3 years of age.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K945154, K861971, K872168, K841432
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
Center for Devices and Radiological Health December 15, 1995 Page -10-
AUG - 9 1996
II. SUMMARY OF SAFETY AND EFFECTIVENESS
Name and Address A.
The Summary of Safety and Effectiveness is being submitted by Nobelpharma USA, Inc., 777 Oakmont Lane, Suite 100, Westmont, IL 60559. Our telephone number is: (708) 654-9100 and the contact person will be the This summary was prepared Director, Regulatory Affairs. On December 15, 1995. g t
B. Name of the Device
This device is generally known as a bone-anchored, bone conduction hearing aid with the trade name "BRANEMARK Bone-Anchored Hearing Aid (BAHA™) System."
The Predicate Product ﺰ
The predicate product used in this Premarket Notification is the BRANEMARK SYSTEM® - Bone-Anchored Craniofacial Prosthetic Attachment System (K945154), the Audiant Bone Conduction Hearing Aid (K861971, K872168 and K841432), and other bone conduction hearing aids.
1
Center for Devices and Radiological Health December 15, 1995 Page -11-
Description of the Device D.
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. ్లో గ్రామం
Intended Use of the Device E.
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)
2
Center for Devices and Radiological Health December 15, 1995 Page -12-
- 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.
-
- 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
Center for Devices and Radiological Health December 15, 1995 Page -13-
-
- 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.
Comparison of Technological Characteristics F.
The technological characteristics between the attachment system, the sound processor and the respective predicate products are substantially identical and no additional questions regarding safety and effectiveness exist.