Who is the manufacturer of MIRACLE EAR & AUDIOTONE MODEL ITE/ITC/CIC?

Miracle-Ear, Inc. filed the 510(k) submission for MIRACLE EAR & AUDIOTONE MODEL ITE/ITC/CIC (K960804).

What is the FDA product code for MIRACLE EAR & AUDIOTONE MODEL ITE/ITC/CIC?

ESD. It is classified under 21 CFR 874.3300 as a Class 1 device in the Ear, Nose, Throat panel.

What is the regulatory pathway for MIRACLE EAR & AUDIOTONE MODEL ITE/ITC/CIC?

510(k) clearance (submission type: Traditional).

What are the predicate devices for MIRACLE EAR & AUDIOTONE MODEL ITE/ITC/CIC?

Dahlberg K-AMP hearing aids (K954941).

Who can help prepare an FDA 510(k) submission like MIRACLE EAR & AUDIOTONE MODEL ITE/ITC/CIC?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MIRACLE EAR & AUDIOTONE MODEL ITE/ITC/CIC

K960804 · Miracle-Ear, Inc. · ESD · Apr 5, 1996 · Ear, Nose, Throat

Device Facts

Record ID	K960804
Device Name	MIRACLE EAR & AUDIOTONE MODEL ITE/ITC/CIC
Applicant	Miracle-Ear, Inc.
Product Code	ESD · Ear, Nose, Throat
Decision Date	Apr 5, 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

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.

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 K-AMP hearing aids (K954941)

Related Devices

K965063 — AUDIOTONE (A-552) · Miracle-Ear, Inc. · Jan 27, 1997
K964669 — MIRACLE-EAR OR AUDIOTONE · Miracle-Ear, Inc. · Dec 26, 1996
K965057 — AUDIOTONE (A554H) · Miracle-Ear, Inc. · Jan 27, 1997
K971845 — HEARTLAND TECHNOLOGIES, ITE, ITC, CIC · Sound Hearing Instruments, Inc. · Aug 15, 1997
K971605 — RESOUND ED4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION · Resound Corp. · Jul 3, 1997

Submission Summary (Full Text)

{0} 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.