K Number
K964504
Device Name
UNITRON MODEL ICON AOHPL +4
Date Cleared
1996-11-27

(19 days)

Product Code
Regulation Number
874.3300
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
To amplify and transmit sound via air conduction to the ear.
Device Description
Behind-The-Ear Hearing Aids. Four fitter controls Power, Compression Limiting, active 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 and other hearing aid manufacturers. Technical specifications comply with ANSI Standard S 3.22-1987. Volume control, similar to other devices. Switch for selecting microphone, telecoil and off. Standard hearing aid battery size 13.
More Information

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No
The device description focuses on standard hearing aid components and functionalities, with no mention of AI or ML.

No
The device is a hearing aid, which amplifies sound to compensate for hearing loss. Hearing aids are considered assistive listening devices rather than therapeutic devices that treat or cure a disease.

No
Explanation: This device is described as a hearing aid, which amplifies and transmits sound to the ear. Its features are focused on sound reproduction and customization, not on identifying diseases or conditions. The "Intended Use" explicitly states amplification and transmission of sound, not diagnosis.

No

The device description explicitly details hardware components such as "Behind-The-Ear Hearing Aids," "Class D circuitry," "telecoil," "battery," and "fitter controls," indicating 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 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 screening.
  • Device Description: The description details a hearing aid, which is a medical device used to treat hearing loss. It does not mention any components or functions related to analyzing biological samples.
  • Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing biological specimens (blood, urine, tissue, etc.)
    • Providing diagnostic information
    • Using reagents or assays

Therefore, this device falls under the category of a medical device, specifically a hearing aid, and 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 Aids. Substantially equivalent Type of Device: to other behind-the-ear hearing aids.
  • Four fitter controls Power, Compression Limiting, active low cut tone, high cut tone. Class D circuitry for excellent battery life. Powerful telecoil with preamplifier.
  • Assembly: Assembled from standard components that are used by Unitron and other hearing aid manufacturers.
  • Technical specifications comply with ANSI Technical Characteristics: Standard S 3.22-1987.
  • Controls: Volume control, similar to other devices. Switch for selecting microphone, telecoil and off.
  • Standard hearing aid battery size 13. Power:

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).

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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

K9644504

NOV 27 1996

A Summary of Safety and Effectiveness Information

Unitron Industries, ICON AoHPL +4 Name of Device:

  • Behind-The-Ear Hearing Aids. 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.
  • 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.
  • Assembly: Assembled from standard components that are used by Unitron and other hearing aid manufacturers.
  • Technical specifications comply with ANSI Technical Characteristics: Standard S 3.22-1987.
  • Controls: Volume control, similar to other devices. 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.