← Product Code [ESD](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD) · K964530

# DAHLBERG HEARING AID WITH MULTI-CHANNEL COMPRESSION CIRCUIT (K964530)

_Miracle-Ear, Inc. · ESD · Nov 27, 1996 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K964530

## Device Facts

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

BTE hearing aid; amplifies and transmits sound to ear. Input: acoustic signals via microphone. Processing: multi-channel compression circuit. Output: amplified sound to ear canal. Used by patients with hearing loss; fitted by hearing healthcare professionals based on audiogram. Power: zinc-air battery. Benefit: improved auditory perception for patients with mild to severe hearing impairment.

## Clinical Evidence

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

## Technological Characteristics

BTE form factor; multi-channel compression circuit; zinc-air battery power; industry-standard shell materials; ANSI S3.22-1987 testing standard.

## 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 multi-channel compression hearing aids ([K960804](/device/K960804.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
NOV 27 1996
K964530

# Summary of Safety and Effectiveness

- **Device Name:** Dahlberg Hearing Aid with multi-channel compression circuit
- **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:** Dahlberg multi-channel compression hearing aids which were cleared for distribution under document control number K960804.
- **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/K964530](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K964530)

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