(19 days)
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No
The summary describes a standard hearing aid with traditional audio processing features and makes no mention of AI or ML.
Yes
The device is a hearing aid, which is used to treat hearing impairment by amplifying sound to the ear.
No
Explanation: The device is described as a "Hearing Aid" which is an amplification device for sound, not a device used to diagnose a medical condition. Its function is to amplify and transmit sound.
No
The device description explicitly states it is a "Behind-The-Ear Hearing Aid" and lists hardware components like "Class D circuitry," "telecoil," and "Directional microphone." This indicates it is a physical hardware 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 clearly identifies it as a "Behind-The-Ear Hearing Aid." Hearing aids are medical devices, but they are not IVDs.
- 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 biological samples
- Providing diagnostic information based on laboratory tests
Therefore, this device falls under the category of a medical device used for hearing assistance, 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 (comma separated list FDA assigned to the subject device)
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Device Description
- Behind-The-Ear Hearing Aids. Substantially equivalent Type of Device: to other behind-the-ear hearing aids.
- Features: Four fitter controls - Power, Compression Limiting, active low cut tone, high cut tone. Class D circuitry for excellent battery life. Powerful telecoil with preamplifier. Directional microphone.
- Assembled from standard components that are used by Unitron Assembly: and other hearing aid manufacturers.
Technical Characteristics: Technical specifications comply with ANSI Standard S 3.22-1987. - Controls: Volume control, similar to other devices. Switch for selecting microphone, telecoil and off.
Power : Standard hearing aid battery - size 13.
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
NOV 27 1996
A Summary of Safety and Effectiveness Information
Unitron Industries, ICON AoHPD +4 Name of Device:
- Behind-The-Ear Hearing Aids. 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: Four fitter controls - Power, Compression Limiting, active low cut tone, high cut tone. Class D circuitry for excellent battery life. Powerful telecoil with preamplifier. Directional microphone.
- Assembled from standard components that are used by Unitron Assembly: and other hearing aid manufacturers.
Technical Characteristics: Technical specifications comply with ANSI Standard S 3.22-1987.
- Controls: Volume control, similar to other devices. Switch for selecting microphone, telecoil and off.
Power : Standard hearing aid battery - size 13.
A user's manual and other information is supplied with each hearing aid.