Who is the manufacturer of AUDIOTONE (A554H)?

Miracle-Ear, Inc. filed the 510(k) submission for AUDIOTONE (A554H) (K965057).

What is the FDA product code for AUDIOTONE (A554H)?

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 AUDIOTONE (A554H)?

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

What are the predicate devices for AUDIOTONE (A554H)?

Audiotone model A-54SR (K941122).

Who can help prepare an FDA 510(k) submission like AUDIOTONE (A554H)?

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.

AUDIOTONE (A554H)

K965057 · Miracle-Ear, Inc. · ESD · Jan 27, 1997 · Ear, Nose, Throat

Device Facts

Record ID	K965057
Device Name	AUDIOTONE (A554H)
Applicant	Miracle-Ear, Inc.
Product Code	ESD · Ear, Nose, Throat
Decision Date	Jan 27, 1997
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 13 battery; intended for patients with mild to severe 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 13 battery power; case materials standard 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

Audiotone model A-54SR (K941122)

Related Devices

K965063 — AUDIOTONE (A-552) · Miracle-Ear, Inc. · Jan 27, 1997
K964669 — MIRACLE-EAR OR AUDIOTONE · Miracle-Ear, Inc. · Dec 26, 1996
K964794 — DAHLBERG K-AMP BTE · Miracle-Ear, Inc. · Dec 23, 1996
K965049 — DAHLBERG (A-554) · Miracle-Ear, Inc. · Jan 27, 1997
K970262 — MULTI-CHANNEL COMPRESSION BTE (SD) · Miracle-Ear, Inc. · Mar 31, 1997

Submission Summary (Full Text)

{0} JAN 27 1997 Appendix B K965057 # Summary of Safety and Effectiveness Device Name: Audiotone A-554H 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: Audiotone model A-54SR which was cleared for distribution under document control number K941122. Registration Number: 2110592 Materials: The hearing aid cases 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: Zinc-Air size 13 battery.