(25 days)
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No
The description focuses on standard hearing aid components and features like K-Amp circuits, telecoil, and basic controls, with no mention of AI or ML.
Yes
The device is a hearing aid, which is used to treat hearing impairment by amplifying sound, thus making it a therapeutic device.
No
Explanation: The device is described as a hearing aid, which amplifies and transmits sound. Its features and function (volume control, tone controls, telecoil) are consistent with a therapeutic or assistive device for hearing, not a diagnostic one. There is no mention of it being used to detect, identify, or monitor a medical condition.
No
The device description clearly outlines a physical, behind-the-ear hearing aid with hardware components like a microphone, telecoil, circuits, controls, and a battery. It is not solely software.
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 from the body to provide diagnostic information.
- Device Description: The description clearly identifies it as a "Behind-the-ear hearing aid." Hearing aids are classified as medical devices, but not as IVDs.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or assays
In summary, this device is a hearing aid, which is a medical device used for treatment/management of hearing loss, not an in vitro diagnostic device used for diagnosis.
N/A
Intended Use / Indications for Use
To amplify and transmit sound via air conduction to the ear.
Product codes
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Device Description
Behind-the-ear hearing aid.
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
ear
Indicated Patient Age Range
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Intended User / Care Setting
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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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 logo is in black and features the word "UNITRON" in large, bold letters. Below the word "UNITRON" is the phrase "INDUSTRIES INC." in smaller letters. Above the logo is the text "K9 63122".
SEP - 6 1996
A Summary of Safety and Effectiveness Information
Unitron Industries, ICON KR Name of Device:
Type of Device: Behind-the-ear hearing aid. Substantially equivalent to other behind-the-ear hearing aids
Intended Use: To amplify and transmit sound via air conduction to the ear.
- Three fitter controls Low Cut Tone, High Cut Tone, Threshold Features: Knee-point. K-Amp circuit with Wide Dynamic Range compression.
Class D circuits for excellent battery life.
Telecoil with pre-amplifier.
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Assembly: Assembled from standard components that are used by Unitron and other hearing aid manufacturers
Technical Characteristics: Technical specifications comply with ANSI Standard S 3.22-1987 -
Fit: Hearing aid adjustment dictates by individual audiogram
Controls: Volume control, similar to other devices. Switch for selecting microphone, telecoil and off.
Power : Standard hearing aid battery - size 13.
A user's guide and other information is supplied with each hearing aid.