MIRACLE - EAR (ITE/ITC/CIC)

K964419 · Miracle-Ear, Inc. · ESD · Feb 4, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K964419
• Device Name: MIRACLE - EAR (ITE/ITC/CIC)
• Applicant: Miracle-Ear, Inc.
• Product Code: ESD · Ear, Nose, Throat
• Decision Date: Feb 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3300
• Device Class: Class 1
• 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.

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

• Miracle-Ear Sharp Plus canal hearing aids (K935265)

Submission Summary (Full Text)

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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.