(19 days)
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No
The description focuses on standard hearing aid components and features like compression circuitry, telecoil, and fitter controls, 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 treat hearing impairment by amplifying sound.
No
Explanation: This device is described as a hearing aid, which amplifies and transmits sound to the ear. Its features, such as fitter controls for gain and frequency, and a telecoil, are for sound modification and transmission, not for diagnosing a medical condition. While hearing aid adjustments are based on an audiogram (which is a diagnostic test), the device itself does not perform diagnostic functions.
No
The device description explicitly states it is a "Behind-The-Ear Hearing Aid" and details hardware components like circuitry, telecoil, and battery, indicating it is a physical device, not software-only.
No, 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 taken from the body.
- Device Description: The description clearly identifies it as a "Behind-The-Ear Hearing Aid." Hearing aids are medical devices that assist with hearing, not diagnostic tools that analyze biological samples.
- 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.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on those samples.
Based on the provided information, this device is a hearing aid, which is a type of medical device, but not an In Vitro Diagnostic.
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)
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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).
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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. The logo is in black and white.
NOV 27 1996
A Summary of Safety and Effectiveness Information
Unitron Industries, Sound F/XP *4 Name of Device:
- Behind-The-Ear Hearing Aid. Substantially equivalent Type of Device: to other behind-the-ear hearing aids.
- Intended Use: To amplify and transmit sound via air conduction to the ear.
- Features: Three fitter controls - Cross over frequency, low channel gain, and threshold knee point. Two channel compression circuitry. Class D circuitry for excellent battery life. Telecoil with pre-amplifier.
- 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 dictated by individual audiogram.
- Volume control, similar to other devices. Switch for Controls: 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.