DAHLBERG HEARING AID WITH MULTI-CHANNEL COMPRESSION CIRCUIT

K964530 · Miracle-Ear, Inc. · ESD · Nov 27, 1996 · Ear, Nose, Throat

Device Facts

• Record ID: K964530
• Device Name: DAHLBERG HEARING AID WITH MULTI-CHANNEL COMPRESSION CIRCUIT
• Applicant: Miracle-Ear, Inc.
• Product Code: ESD · Ear, Nose, Throat
• Decision Date: Nov 27, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3300
• Device Class: Class 1
• 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.

Indications for Use

Indicated for individuals with mild to severe hearing loss as determined by an audiogram.

Regulatory Classification

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)

Submission Summary (Full Text)

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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.