(50 days)
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No
The description details a traditional analog pocket hearing aid with standard components and manual adjustments. There is no mention of digital signal processing, adaptive algorithms, or any terms associated with AI/ML.
Yes
The device is a hearing aid, which is designed to provide amplification for hearing loss, indicating a therapeutic purpose.
No
Explanation: The device is described as a "Pocket Hearing Instruments" designed to "amplify and transmit sound to the ear" and "provide amplification for a wide range of hearing losses." There is no indication that it is used to diagnose hearing loss or any other condition; its purpose is to provide amplification, which is a treatment or assistive function.
No
The device description clearly outlines physical hardware components such as a body-worn amplifier, electrical earphone cable, earpiece, controls (volume wheel, toggle switch), and a battery. This indicates it is a hardware device with potential software/firmware components, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Function: The description clearly states the device's intended use is "To amplify and transmit sound to the ear." This is a function performed on the body (in vivo) to assist with hearing.
- No Sample Analysis: The description does not mention any analysis of biological samples. The device works by processing and amplifying sound waves.
Therefore, based on the provided information, the VITA 160 Series Pocket Hearing Instruments are not IVDs. They are hearing aids, which are a different category of medical device.
N/A
Intended Use / Indications for Use
To amplify and transmit sound to the ear. The VITA 160 Series Pocket Hearing Instruments (Models 162E, 166M and 168PP) are designed to provide amplification for a wide range of hearing losses, from moderate to profound.
Product codes
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Device Description
The VITA 160 Series Pocket Hearing Instruments (Models 162E, 166M and 168PP) are designed to provide amplification for a wide range of hearing losses, from moderate to profound. Sound is transmitted from the body-worn amplifier to a non-custom earpiece through a standard electrical earphone cable. The VITA 162E and 166M medium power models both provide 132dB peak output and 65dB peak gain. They include a telecoil with O-T-M switch (Off-Telecoil-Microphone) and an Audio Input socket. The VITA 166M medium power model additionally provides two controls for the dispenser to adjust: Low Frequency Tone (NH) and Maximum Power Output (PC). The VITA 168PP high power model provides 142dB peak output and 79dB peak gain. It includes a telecoil with O-T-M switch (Off-Telecoil-Microphone) and an Audio Input socket. Three controls are provided for the dispenser to adjust: Low Frequency Tone (NH),Gain and Output Compression (AGC-O). Assembled from standard components which are widely utilized by other hearing aid manufacturers. Technical specifications comply with S3.22-1987 ANSI Specifications. The frequency response of the product is included. Some adjustments may be made by the dispenser to adjust the amplification to the audiogram of the patient. User controls include an adjustable volume control wheel and an M-T-O 3 position toggle switch. Uses one standard AA Size battery.
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
SIEMENS
UL 25 1996
A SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
VITA 160 Series Pocket Hearing Instruments Name of Device: Body (Pocket) Hearing Aid - Substantially equivalent to other Body worn Type of Device: (Pocket) hearing aids. Intended Use: To amplify and transmit sound to the ear. The VITA 160 Series Pocket Hearing Instruments (Models 162E, 166M and Features: 168PP) are designed to provide amplification for a wide range of hearing losses, from moderate to profound. Sound is transmitted from the body-worn amplifier to a non-custom earpiece through a standard electrical earphone cable. The VITA 162E and 166M medium power models both provide 132dB peak output and 65dB peak gain. They include a telecoil with O-T-M switch (Off-Telecoil-Microphone) and an Audio Input socket. The VITA 166M medium power model additionally provides two controls for the dispenser to adjust: Low Frequency Tone (NH) and Maximum Power Output (PC). The VITA 168PP high power model provides 142dB peak output and 79dB peak gain. It includes a telecoil with O-T-M switch (Off-Telecoil-Microphone) and an Audio Input socket. Three controls are provided for the dispenser to adjust: Low Frequency Tone (NH),Gain and Output Compression (AGC-O). Assembly: Assembled from standard components which are widely utilized by other hearing aid manufacturers. Technical Characteristics: Technical specifications comply with S3.22-1987 ANSI Specifications. Fit: The frequency response of the product is included. Some adjustments may be made by the dispenser to adjust the amplification to the audiogram of the patient. Controls: User controls include an adjustable volume control wheel and an M-T-O 3 position toggle switch. Uses one standard AA Size battery. Power:
A user's manual and other information is supplied with each pocket aid.