(72 days)
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Not Found
No
The description focuses on standard hearing aid technology (amplification, compression, programmable parameters) and explicitly states "Mentions AI, DNN, or ML: Not Found".
No.
The intended use is to amplify and transmit sound to the ear, which is characteristic of a hearing aid, a non-therapeutic device for managing hearing loss rather than treating a disease or condition.
No
The text explicitly states the device is a "Programmable Hearing Aid" used to "amplify and transmit sound via air conduction to the ear", which are functions of a therapeutic device, not a diagnostic one.
No
The device description clearly outlines hardware components such as circuitry, battery, and physical controls, indicating it is a physical hearing aid, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "To amplify and transmit sound via air conduction to the ear." This describes a device that interacts with the body to improve hearing, not a device used to examine specimens (like blood, urine, or tissue) outside the body to diagnose diseases or conditions.
- Device Description: The description details a hearing aid, which is a medical device designed to assist with hearing loss. It describes components and functionalities related to sound amplification and processing for the ear.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens.
- Detecting or measuring substances in specimens.
- Providing information for diagnosis, monitoring, or screening of diseases.
Therefore, this device falls under the category of a medical device, specifically a hearing aid, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
To amplify and transmit sound via air conduction to the ear .
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
Unitron Industries, Sound F/X Programmable Name of Device: In-The-Ear Programmable Hearing Aid. Substantially equivalent to other In-The-Ear Programmable hearing aids.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ear
Indicated Patient Age Range
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 874.3300 Air-conduction hearing aid.
(a)
Identification. An air-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. An air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. The air-conduction hearing aid generic type excludes the group hearing aid or group auditory trainer, master hearing aid, and the tinnitus masker, regulated under §§ 874.3320, 874.3330, and 874.3400, respectively.(b)
Classification. Class I (general controls). This device is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 874.9.
0
Image /page/0/Picture/0 description: The image shows the logo for Unitron Industries Inc. The text is in a bold, sans-serif font. The word "UNITRON" is on the top line, and the words "INDUSTRIES INC." are on the bottom line. The logo is black and white.
APR 2 4 1997
A Summary of Safety and Effectiveness Information
- Unitron Industries, Sound F/X Programmable Name of Device:
- In-The-Ear Programmable Hearing Aid. Substantially Type of Device: equivalent to other In-The-Ear Programmable hearing aids.
- To amplify and transmit sound via air conduction to the Intended Use: ear .
- Five programmable parameters: Low-channel Gain, High-channel Features: Gain, Cross-over Frequency, Threshold Kneepoint, Power.
Two channels with wide dynamic range compression circuitry independently adjustable for each channel.
Twin average compression detectors.
Class D circuitry for excellent battery life.
- Assembled from standard components that are used by Unitron Assembly: and other hearing aid manufacturers.
- Technical Specifications comply with ANSI Technical Characteristics: Standard S 3.22-1987.
Volume Control, similar to other devices. Controls:
- Standard hearing aid battery size 13, 312 or 10A. Power:
A user's manual and other information is supplied with each hearing aid.