← Product Code [ESD](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD) · K965057

# AUDIOTONE (A554H) (K965057)

_Miracle-Ear, Inc. · ESD · Jan 27, 1997 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K965057

## Device Facts

- **Applicant:** Miracle-Ear, Inc.
- **Product Code:** [ESD](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD.md)
- **Decision Date:** Jan 27, 1997
- **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

BTE hearing aid; amplifies and transmits sound to ear; powered by Zinc-Air size 13 battery; intended for patients with mild to severe hearing loss; performance data obtained via ANSI S3.22-1987 methodology.

## Clinical Evidence

Bench testing only; performance data obtained using ANSI S3.22-1987 methodology.

## Technological Characteristics

BTE hearing aid; Zinc-Air size 13 battery power; case materials standard to industry; performance testing per 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.

## Predicate Devices

- Audiotone model A-54SR ([K941122](/device/K941122.md))

## Submission Summary (Full Text)

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>
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JAN 27 1997
Appendix B
K965057

# Summary of Safety and Effectiveness

Device Name: Audiotone A-554H BTE

Device Type: BTE Hearing Aid

Classification: Air Conduction Hearing Aid (77ESD), Class I. ☑

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

Substantially Equivalent to: Audiotone model A-54SR which was cleared for distribution under document control number K941122.

Registration Number: 2110592

Materials: The hearing aid cases will be manufactured from materials that are commonly used in the industry.

Technical Characteristics: Dahlberg utilizes the ANSI S3.22-1987 methodology to test and obtain performance data for hearing aids.

Fit: Mild to severe as dictated by the individual users audiogram.

Power: Zinc-Air size 13 battery.

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K965057](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K965057)

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