(19 days)
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No
The description focuses on standard hearing aid components and functionalities, with no mention of AI or ML terms or capabilities.
Yes
The device is a hearing aid, which is designed to improve hearing by amplifying and transmitting sound, thus addressing a physiological impairment and fitting the definition of a therapeutic device.
No
Explanation: The device description states its purpose is to "amplify and transmit sound via air conduction to the ear," which clearly defines it as a hearing aid, not a diagnostic tool. Hearing aids assist with hearing, they don't diagnose conditions.
No
The device description clearly outlines hardware components such as "Behind-The-Ear Hearing Aids," "Class D circuitry," "telecoil," "Volume Control," "Switch," and "Standard hearing aid battery." This indicates it is a physical 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 transmitt sound via air conduction to the ear." This describes a device that interacts with the physical world (sound waves) and the human body (the ear) to improve hearing.
- 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 key characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a disease or condition based on the analysis of biological samples.
- Using reagents or other materials to perform tests on biological samples.
IVDs are devices used to perform tests on samples taken from the human body to provide information about a person's health. This hearing aid does not perform such tests.
N/A
Intended Use / Indications for Use
To amplify and transmitt 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.
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
A Summary of Safety and Effectiveness Information
Unitron Industries, ICON AoHP +4 Name of Device:
Behind-The-Ear Hearing Aids. Substantially equivalent Type of Device: to other behind-the-ear hearing aids.
To amplify and transmitt sound via air conduction to the Intended Use: ear.
Four fitter controls - Power, Compression Limiting, active Features: low cut tone, high cut tone. Class D circuitry for excellent battery life. Powerful telecoil with preamplifier.
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.
Volume Control, similar to other devices. Controls: Switch for selecting microphone, telecoil and off.
Standard hearing aid battery - size 13. Power :
A user's manual and other information is supplied with each hearing aid.
6
Nov. 27, 1996