← Product Code [ESD](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD) · K964419

# MIRACLE - EAR (ITE/ITC/CIC) (K964419)

_Miracle-Ear, Inc. · ESD · Feb 4, 1997 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K964419

## Device Facts

- **Applicant:** Miracle-Ear, Inc.
- **Product Code:** [ESD](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD.md)
- **Decision Date:** Feb 4, 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

Dahlberg Sharp Plus and BILL hearing aids; CIC, ITC, and ITE form factors. Device amplifies and transmits sound to ear; battery-powered. Used by patients with mild to severe hearing loss; fit based on individual audiogram. Shells manufactured from industry-standard materials.

## Clinical Evidence

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

## Technological Characteristics

Air conduction hearing aid; CIC, ITC, ITE form factors. Materials: industry-standard shell materials. Testing standard: ANSI S3.22-1987. Power: battery-operated.

## 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

- Miracle-Ear Sharp Plus canal hearing aids ([K935265](/device/K935265.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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APPENDIX B
FEB - 4 1997
K964419

# Summary of Safety and Effectiveness

Device Name: Dahlberg Sharp Plus and BILL Hearing Aids

Device Type: CIC, ITC and ITE Hearing Aids

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

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

Substantially Equivalent to: Miracle-Ear Sharp Plus canal hearing aids which were cleared for distribution under 510(k) #K935265.

Registration Number: 2110592

Materials: The hearing aid shells 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: 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/K964419](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K964419)

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