← Product Code [ESD](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD) · K955930

# BELTONE COMPOSER 2000 BTE HP (K955930)

_Beltone Electronics Corp. · ESD · Mar 1, 1996 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K955930

## Device Facts

- **Applicant:** Beltone Electronics Corp.
- **Product Code:** [ESD](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD.md)
- **Decision Date:** Mar 1, 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

Air conduction hearing aid; amplifies and transmits sound to ear. Features dispenser programmability and user remote control. Assembled from standard industry components. Powered by standard hearing aid battery. Operated by patient; audiological characteristics dictated by individual audiogram. Controls include volume, switches, and dispenser-operated trimmers.

## Clinical Evidence

No clinical data; bench testing only.

## Technological Characteristics

Air conduction BTE hearing aid; standard battery power; dispenser programmable; user remote control; volume/switch/trimmer controls. Technical specifications comply with ANSI S3.22-1987 standards.

## 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.

## Predicate Devices

- Maico Gamma RD BTE HP ([K933291](/device/K933291.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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K955930

# A SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

NAME OF DEVICE: Beltone Composer 2000 BTE HP

TYPE OF DEVICE: The Beltone Composer 2000 BTE HP Air Conduction Hearing Aid is identical to the Maico Gamma RD BTE HP programmable hearing aid (K933291) with the exception of changes to the labeling.

INTENDED USE: To amplify and transmit sound to the ear

FEATURES: Dispenser programmable User remote control

ASSEMBLY: Assembled from standard components that are widely used by other hearing aid manufacturers

TECHNICAL CHARACTERISTICS: Technical specifications comply with S3.22-1987 ANSI Standards

FIT: Audiological characteristics dictated by individual audiogram

CONTROLS: Volume control, switches, and optional dispenser operated trimmer controls similar to those of other devices

POWER: Standard hearing aid battery

A USER'S MANUAL AND OTHER INFORMATION IS SUPPLIED WITH EACH HEARING AID.

![img-0.jpeg](img-0.jpeg)

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K955930](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K955930)

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