K Number
K960741
Device Name
COMFORTONE PHS
Date Cleared
1996-05-07

(74 days)

Product Code
Regulation Number
874.3300
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
To amplifiy and transmit sound to the ear.
Device Description
In The Ear Hearing Aid - Substantially equivalent to other In The Ear (ITE) hearing aids. Controls volume, gain, peak clipper, AGC, kneepoint low frequency out and high frequency out as appropriate. Assembled from standard components which are widely utilized by other hearing aid manufacturers. Technical specifications comply with S3.22-1987 ANSI Specifications, Preliminary data sheets for the PHS models are enclosed. The frequency response of this product is dictated by the individual audiogram from each client. Standard hearing aid battery.
More Information

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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 used to amplify sound for individuals with hearing impairment, making it a therapeutic device designed to treat a medical condition.

No
The provided text describes a hearing aid, which is a device that amplifies and transmits sound to the ear to improve hearing. This is a therapeutic device aimed at alleviating hearing loss, not diagnosing a medical condition.

No

The device description explicitly states it is an "In The Ear Hearing Aid" assembled from "standard components" and uses a "Standard hearing aid battery," indicating it is a physical hardware device.

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 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 for the purpose of providing information for diagnosis, monitoring, or treatment.
  • Device Description: The description clearly outlines a hearing aid, which is a medical device used to treat hearing loss by amplifying sound. It doesn't 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 amplifiy and transmit sound to the ear.

Product codes

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Device Description

In The Ear Hearing Aid - Substantially equivalent to other In The Ear (ITE) hearing aids.
Features: Controls volume, gain, peak clipper, AGC, kneepoint low frequency out and high frequency out as appropriate.
Assembly: Assembled from standard components which are widely utilized by other hearing aid manufacturers.
Technical Characteristics: Technical specifications comply with S3.22-1987 ANSI Specifications, Preliminary data sheets for the PHS models are enclosed.
Fit: The frequency response of this product is dictated by the individual audiogram from each client.
Power: Standard hearing aid battery.

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

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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

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Key Metrics

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Predicate Device(s)

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Reference Device(s)

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Predetermined Change Control Plan (PCCP) - All Relevant Information

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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

K960741

MAY - 7 1996

A SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

NAME OF DEVICE:COMFORTONE PHS HEARING AID
TYPE OF DEVICE:In The Ear Hearing Aid - Substantially equivalent to other In
The Ear (ITE) hearing aids.
INTENDED USE:To amplifiy and transmit sound to the ear.
FEATURES:Controls volume, gain, peak clipper, AGC, kneepoint low
frequency out and high frequency out as appropriate.
ASSEMBLY:Assembled from standard components which are widely utilized
by other hearing aid manufacturers.
TECHNICAL
CHARACTERISTICS:Technical specifications comply with S3.22-1987 ANSI
Specifications, Preliminary data sheets for the PHS models are
enclosed.
FIT:The frequency response of this product is dictated by the
individual audiogram from each client.
POWER:Standard hearing aid battery.

A users manual and other information is supplied with each hearing aid (enclosed).

Image /page/0/Picture/5 description: The image shows a circular object with a rough, textured surface. The texture appears to be composed of small, irregular shapes or particles, creating a mottled effect across the surface. The object is uniformly colored, with no distinct features or patterns other than the texture itself. The overall impression is that of a grainy or speckled sphere.

Image /page/0/Picture/6 description: The image shows a black and white close-up of a tree. The tree has a round shape and is covered in leaves. The tree is in the center of the image and is surrounded by a white background.

Image /page/0/Picture/7 description: The image shows a circular object with a rough, textured surface. The object appears to be dark in color, possibly black or a very dark shade of gray. The texture is uneven, with variations in light and shadow across the surface, suggesting a three-dimensional form. The background is plain and white, which helps to highlight the object.