← Product Code [ESD](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD) · K960804

# MIRACLE EAR & AUDIOTONE MODEL ITE/ITC/CIC (K960804)

_Miracle-Ear, Inc. · ESD · Apr 5, 1996 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K960804

## Device Facts

- **Applicant:** Miracle-Ear, Inc.
- **Product Code:** [ESD](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD.md)
- **Decision Date:** Apr 5, 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 (CIC, ITC, or ITE styles); amplifies and transmits sound to ear; powered by zinc-air batteries; intended for use by individuals with hearing loss; performance data obtained via ANSI S3.22-1987 methodology.

## Clinical Evidence

No clinical data; bench testing only per ANSI S3.22-1987.

## Technological Characteristics

Air conduction hearing aid; CIC, ITC, or ITE form factors; zinc-air battery power; materials common 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

- Dahlberg K-AMP hearing aids ([K954941](/device/K954941.md))

## Submission Summary (Full Text)

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K96 0804
Appendix B
APR - 5
K960804

# Summary of Safety and Effectiveness

Device Name: Dahlberg Hearing Aid with multi-channel compression circuit

Device Type: CIC, ITC or ITE Hearing Aid

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

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

Substantially Equivalent to: Dahlberg K-AMP hearing aids which were cleared for distribution under document control number K954941.

Registration Number: 2110592

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

Assembly: The hearing aid will be assembled utilizing similar assembly practices as Dahlberg's current products.

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 battery size dependent on hearing aid model.

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K960804](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K960804)

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