(56 days)
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Not Found
No
The summary describes a standard hearing aid and explicitly states "Not Found" for mentions of AI, DNN, or ML, as well as information typically associated with AI/ML development like training/test sets and performance metrics.
No
The device is described as an "amplifies and transmits sound via air conduction to the ear" and "Behind-The-Ear Hearing Aid," which aids in hearing but does not treat a medical condition.
No
Explanation: The device is described as a hearing aid, which amplifies and transmits sound. Its stated purpose is to assist with hearing, not to diagnose a condition or disease.
No
The device description explicitly states it is a "Behind-The-Ear Hearing Aid," which is a hardware device. The summary does not mention any software-only components or functions.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of this device is to "amplify and transmit sound via air conduction to the ear." This involves interacting with the ear directly, not analyzing biological samples.
- The device description is a hearing aid. Hearing aids are medical devices, but they are not IVDs. They are designed to assist with hearing, not to diagnose or monitor a condition by testing samples.
The information provided clearly indicates a device for improving hearing, which falls outside the scope of in vitro diagnostics.
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.
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)
Not Found
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, in a smaller font, is the word "INDUSTRIES" followed by "INC."
K GL-0155
MAR - 7 199
A Summary of Safety and Effectiveness Information
Unitron Industries, Sound F/XP 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 circuirry.
Class D circuitry for excellent battery life.
Telecoil with pre-amplifier.
Direction Microphone.
- 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.