(72 days)
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No
The description focuses on standard hearing aid technology like compression, gain control, and circuitry, with no mention of AI or ML terms or functionalities.
Yes
The device is described as a hearing aid, which is a therapeutic device designed to improve hearing for individuals with hearing loss.
No
Explanation: The device is described as a "Completely-In-The-Canal Hearing Aid" that amplifies and transmits sound. Its features and intended use are focused on sound amplification for hearing, not on diagnosing medical conditions.
No
The device description explicitly details hardware components like circuitry, battery, and physical controls, indicating it is a physical medical device, not software-only.
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 derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details a hearing aid, which is a medical device used to treat hearing loss. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological specimens (blood, urine, tissue, etc.)
- Diagnostic testing
- Laboratory use
- Reagents or assays
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
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Device Description
Type of Device: - Completely-In-The-Canal Hearing Aid. Substantially equivalent to other Completely-In-The-Canal hearing aids. Features: Two channel wide dynamic range compression. Six adjustable parameters: Low-channel Gain, High-channel Gain, See-Saw, Cross Over Frequency, Threshold Knee-point and power. Twin average compression detectors. Class D Circuitry for excellent battery life. 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. Controls: Screw set Volume Control, similar to other CIC devices. Power: Standard hearing aid battery - size 10A or 5A.
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 word "UNITRON" is in large, bold, sans-serif font on the top line. Below that, "INDUSTRIES INC." is in a smaller, sans-serif font.
MAY - 8 1997
A Summary of Safety and Effectiveness Information
Unitron Industries, Sound F/X CIC Name of Device:
- Completely-In-The-Canal Hearing Aid. Substantially Type of Device: equivalent to other Completely-In-The-Canal hearing aids.
- Intended Use: To amplify and transmit sound via air conduction to the ear. ﺮ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ
Features: Two channel wide dynamic range compression.
Six adjustable parameters: Low-channel Gain, High-channel Gain, See-Saw, Cross Over Frequency, Threshold Knee-point and power.
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.
- Controls: Screw set Volume Control, similar to other CIC devices.
Power: Standard hearing aid battery - size 10A or 5A.
A user's manual and other information is supplied with each hearing aid.