← Product Code [ESD](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD) · K960741

# COMFORTONE PHS (K960741)

_Comfortone America'S Value Hearing Aid Line · ESD · May 7, 1996 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K960741

## Device Facts

- **Applicant:** Comfortone America'S Value Hearing Aid Line
- **Product Code:** [ESD](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD.md)
- **Decision Date:** May 7, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.3300
- **Device Class:** Class 1
- **Review Panel:** Ear, Nose, Throat
- **Attributes:** Therapeutic

## Intended Use

To amplify and transmit sound to the ear.

## Device Story

ComfortOne PHS Hearing Aid; in-the-ear (ITE) device; amplifies and transmits sound to ear. Operates via standard hearing aid components; features include volume control, gain, peak clipper, AGC, and frequency output adjustments. Frequency response customized based on individual client audiogram. Powered by standard hearing aid battery. Used by patients with hearing impairment; fitted by hearing healthcare professionals based on audiometric data to improve auditory perception.

## Clinical Evidence

No clinical data; bench testing only.

## Technological Characteristics

In-the-ear (ITE) form factor; standard hearing aid components; battery-powered; frequency response adjustable per audiogram; controls include volume, gain, peak clipper, AGC, and frequency output. Complies with ANSI S3.22-1987 specifications.

## Regulatory 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.

## Submission Summary (Full Text)

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>
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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 amplify 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).

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K960741](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K960741)

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