← Product Code [ESD](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD) · K970537

# REXTON MODEL 48 AND 49PP (K970537)

_Rexton, Inc. · ESD · Mar 28, 1997 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K970537

## Device Facts

- **Applicant:** Rexton, Inc.
- **Product Code:** [ESD](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD.md)
- **Decision Date:** Mar 28, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.3300
- **Device Class:** Class 1
- **Review Panel:** Ear, Nose, Throat
- **Attributes:** Therapeutic

## Indications for Use

To amplify and transmit sound to the ear.

## Device Story

Body-worn hearing aids (Model 48 and 49PP); small, slim-lined design for pocket or clothing concealment. Inputs: acoustic sound via microphone or external audio source via audio input jack. Operation: standard hearing aid amplification circuitry; 3-position switch (off/telecoil/microphone). Output: amplified sound delivered to ear. Used by hearing-impaired patients; frequency response customized based on individual audiogram. Powered by standard AA battery.

## Clinical Evidence

No clinical data; bench testing only. Technical specifications comply with S3.22-1987 ANSI standards.

## Technological Characteristics

Body-worn hearing aid; standard components; AA battery power; 3-position switch (off/telecoil/microphone); audio input jack. Technical specifications comply with ANSI S3.22-1987.

## 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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k972537

# MAR 28 1997

# A SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

Name of Device: Rexton's Model 48 and 49PP

Type of Device: Body Aid – Substantially equivalent to other body aids.

Intended Use: To amplify and transmit sound to the ear.
MAR 28 1997

Features: Both the 48 and the 49PP are small slim-lined body aids. Their unique shape fits snugly and inconspicuously into any pocket or other places, e.g. brasiere etc. The 48 and the 49PP both have audio input that allows the connection to external sources. Also both have 3 position switch for off-telecoil-microphone.

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 48 and 49PP are enclosed.

Fit: The frequency response of this product is dictated by the individual audiogram from each client.

Power: Standard battery size AA.

A user's manual and other information is supplied with each hearing aid (enclosed).

Rexton, inc. 510(k) submission; page 2

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K970537](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K970537)

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