(19 days)
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Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description is of a standard hearing aid.
No
The device is a hearing aid, which amplifies sound. While it aids hearing, it does not treat or cure a disease or condition, making it not a therapeutic device in the medical sense.
No
The device is described as a hearing aid, which amplifies sound to assist hearing, not to diagnose a condition. Its intended use is to "amplify and transmit sound via air conduction to the ear," which is a treatment or assistive function, not a diagnostic one.
No
The device description explicitly states it is a "Behind-The-Ear Hearing Aid" assembled from "standard components," indicating it is a physical hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The provided description clearly states the device's intended use is "To amplify and transmit sound via air conduction to the ear." This is a function related to hearing, not to analyzing biological specimens.
- Device Description: The description of a "Behind-The-Ear Hearing Aid" further confirms its purpose is to assist with hearing, not perform diagnostic tests on samples.
The information provided about the device's function, description, and lack of any mention of analyzing biological samples strongly indicates it is a hearing aid, which is a medical device but not an IVD.
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
Behind-The-Ear Hearing Aid. Substantially equivalent to other behind-the-ear hearing aids.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
ear
Indicated Patient Age Range
Not Found
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.
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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.
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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 word "UNITRON" is in large, bold, sans-serif font on the top line. Below that, "INDUSTRIES INC." is in a smaller, sans-serif font. The logo is black on a white background.
NOV 27 1996
A Summary of Safety and Effectiveness Information
- Unitron Industries, Sound F/X +4 Name of Device:
- Behind-The-Ear Hearing Aid. Substantially equivalent Type of Device: to other behind-the-ear hearing aids.
- To amplify and transmit sound via air conduction to the Intended Use: ear.
- Three fitter controls Cross over frequency, low channel gain, Features: and threshold knee point.
Two channel compression circuitry.
Class D circuitry for excellent battery life.
Telecoil with pre-amplifier.
- 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.
Hearing aid adjustment dictated by individual audiogram. Fit:
- Volume control, similar to other devices. Switch for Controls: selecting microphone, telecoil and off.
Standard hearing aid battery - size 13. Power:
A user's guide and other information is supplied with each hearing aid.