Who is the manufacturer of MIRACLE-EAR OR AUDIOTONE?

Miracle-Ear, Inc. filed the 510(k) submission for MIRACLE-EAR OR AUDIOTONE (K964669).

What is the FDA product code for MIRACLE-EAR OR AUDIOTONE?

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 OR AUDIOTONE?

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

Who can help prepare an FDA 510(k) submission like MIRACLE-EAR OR AUDIOTONE?

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 OR AUDIOTONE

K964669 · Miracle-Ear, Inc. · ESD · Dec 26, 1996 · Ear, Nose, Throat

Device Facts

Record ID	K964669
Device Name	MIRACLE-EAR OR AUDIOTONE
Applicant	Miracle-Ear, Inc.
Product Code	ESD · Ear, Nose, Throat
Decision Date	Dec 26, 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; powered by Zinc-Air size 675 battery; used by patients with moderate to profound hearing loss; performance data obtained via ANSI S3.22-1987 methodology.

Clinical Evidence

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

Technological Characteristics

BTE hearing aid; Zinc-Air size 675 battery power; industry-standard case materials; performance testing per ANSI S3.22-1987.

Indications for Use

Indicated for individuals with moderate to profound 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 HL BTE (K926092)

Related Devices

K965063 — AUDIOTONE (A-552) · Miracle-Ear, Inc. · Jan 27, 1997
K965057 — AUDIOTONE (A554H) · Miracle-Ear, Inc. · Jan 27, 1997
K965049 — DAHLBERG (A-554) · Miracle-Ear, Inc. · Jan 27, 1997
K964794 — DAHLBERG K-AMP BTE · Miracle-Ear, Inc. · Dec 23, 1996
K960804 — MIRACLE EAR & AUDIOTONE MODEL ITE/ITC/CIC · Miracle-Ear, Inc. · Apr 5, 1996

Submission Summary (Full Text)

{0} K964669 Appendix B # Summary of Safety and Effectiveness DEC 26 1996 Device Name: Dahlberg Power BTE 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: Miracle-Ear HL BTE which was cleared for distribution under document control number K926092. Registration Number: 2110592 Materials: The hearing aid cases 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: Moderate to profound as dictated by the individual users audiogram. Power: Zinc-Air size 675 battery.