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visual reinforce audio cassette unit basic adv
Colorado Hearing Systems
Summary: The Visual Reinforce Audio Cassette Unit Basic Adv is a device used in audiology to assist with hearing assessments, particularly in pediatric populations. Audiologists and hearing specialists commonly use it to evaluate auditory responses.
FDA Clearance Information
Pathway
510K
Number
K880259 ↗
Decision Date
April 3, 1989
Product Code
LYN
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on April 3, 1989. It is manufactured by Colorado Hearing Systems and classified as a Class II device under product code LYN.
What It Is
The Visual Reinforce Audio Cassette Unit Basic Adv is an audiological device designed to reinforce auditory stimuli with visual cues. It is primarily used in hearing assessments to evaluate auditory responses by providing visual reinforcement, which can be particularly effective in pediatric patients who may not respond consistently to auditory stimuli alone.
Clinical Applications
This device is commonly used in audiology clinics and pediatric hearing centers. It is particularly useful in assessing hearing in young children who may have difficulty understanding or responding to traditional audiological tests. By pairing auditory stimuli with visual reinforcement, clinicians can obtain more reliable responses from children, aiding in the diagnosis of hearing impairments.
Indications for Use
The device is indicated for use in auditory assessments where visual reinforcement can enhance the reliability of responses. It is particularly beneficial for pediatric patients or individuals with developmental delays who may not respond consistently to auditory stimuli alone.
Practical Considerations
The device is typically used in a controlled clinical setting where visual and auditory stimuli can be synchronized. It is important to ensure compatibility with existing audiological equipment and to be familiar with the setup and operation to maximize its effectiveness in hearing assessments.
Frequently Asked Questions
What is the Visual Reinforce Audio Cassette Unit Basic Adv used for?
It is used to assist in hearing assessments by providing visual reinforcement to auditory stimuli, particularly in pediatric patients.
What specialties typically use this device?
Audiologists and hearing specialists, especially those working in pediatric audiology, commonly use this device.
What are the FDA-cleared indications?
The device is cleared for use in auditory assessments where visual reinforcement can improve response reliability, especially in children.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.